Peripheral/Endo

Rep. Hillary Scholten and the National Blood Clot Alliance Award Corewell Health Butterworth Hospital as a VTE Center of Excellence

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GRAND RAPIDS, Mich., June 26, 2024 /PRNewswire/ — On June 24, 2024, Rep. Hillary Scholten (MI-03) joined members of the National Blood Clot Alliance “NBCA” (www.stoptheclot.org) to present NBCA’s inaugural Venous Thromboembolism (VTE) Center of Excellence (COE) award to Corewell Health Grand Rapids Hospitals – Butterworth Hospital. This award recognizes the hospital’s outstanding commitment to providing the highest standard of care, patient education, and follow-up treatment for VTE patients.

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Rep. Hillary Scholten (MI-03) (center) presents the inaugural NBCA VTE Center of Excellence Award to the Corewell Health team. Pictured from left to right: Glen VanOtteren, Erin VanDyke, PA-C, MPAS, Michael Knox, MD, and Trevor Cummings, MD, FACEP.

Rep. Scholten stated, “Our friends, families, neighbors, and the wider community can trust the commitment to excellence demonstrated by Corewell’s clinicians.  These incredible providers ensure that all patients, not just some, will receive the highest standard of care when being diagnosed and treated for VTE.  I was delighted to submit a FY25 appropriations request to fund a nationwide public awareness campaign and to train healthcare providers to recognize the symptoms of blood clots. West Michigan is leading the way in addressing this public health crisis, setting a model for both the Great Lakes State and our nation.”

Dr. Michael Knox, MD, FACR, and Co-Director of the Corewell PERT Program, accepted the award on behalf of Corewell. He stated, “I am honored to accept this award on behalf of my team and thank NBCA for this distinction. We appreciate Rep. Scholten’s acknowledgement of the important work we are doing. Tackling this public health crisis will take all of us working together — hospitals, clinicians, patients, and Members of Congress.”
Justin Crockett, NBCA Board Member and Chair of the NBCA VTE COE Committee, added, “Development of this VTE COE designation has been a long journey. We are very proud to present this award and to start reducing the incidence and mortality of VTE, which claims the lives of 100,000 people each year from all age groups and walks of life. We are especially grateful for Congresswoman Scholten’s support and in recognizing the toll VTE takes on both the citizens of Michigan and the entire nation. We also thank her for supporting NBCA’s $5 million federal appropriations request directing funding to the Centers for Disease Control and Prevention’s (CDC) Division of Blood Disorders and Genomics for a national VTE education, awareness, and prevention program for both the public and clinicians.”VTE (venous blood clots) claims the lives of 100,000 Americans each year while impacting another 900,000 individuals. It is the third leading cause of cardiovascular death and the second cause of sudden unexpected death. It kills more people each year than HIV/AIDS, breast cancer and motor vehicle accidents combined. Nearly half of all VTE cases occur in a hospital or post-hospital setting, yet, according to the CDC, 70% of these cases are preventable.  It is estimated that the annual cost to the US healthcare system is $10 billion per annum.About the National Blood Clot Alliance The National Blood Clot Alliance, established in 2003, is the nation’s leading nonprofit, patient advocacy organization dedicated to advancing the prevention, early diagnosis, and successful treatment of life-threatening blood clots, such as deep vein thrombosis (DVT) and pulmonary embolism (PE), DVT +PE=VTE. Each year NBCA provides blood clot information, resources, and support to more than 3 million people. For more information about NBCA please contact [email protected] or visit www.stoptheclot.org.About Corewell Health™People are at the heart of everything we do, and the inspiration for our legacy of outstanding outcomes, innovation, strong community partnerships, philanthropy and transparency. Corewell Health is a not-for-profit health system that provides health care and coverage with an exceptional team of 65,000+ dedicated people—including more than 12,000 physicians and advanced practice providers and more than 15,500 nurses providing care and services in 21 hospitals, 300+ outpatient locations and several post-acute facilities—and Priority Health, a provider-sponsored health plan serving more than 1.3 million members. Through experience and collaboration, we are reimagining a better, more equitable model of health and wellness. For more information, visit www.corewellhealth.org.About Rep. Hillary Scholten:Congresswoman Hillary J. Scholten is honored to serve the people of Michigan’s Third Congressional District, a diverse district that is anchored by the urban centers of Grand Rapids, Muskegon, and Grand Haven, and includes suburbs, farmland, and miles of beautiful Lake Michigan shoreline.Congresswoman Scholten is a fourth-generation West Michigander.  For more information visit www.hillaryscholten.com.SOURCE National Blood Clot Alliance

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Milestone Phase II Clinical Study Demonstrates Niagen®, Patented Nicotinamide Riboside (NR), Improves Functional Mobility for Individuals with Peripheral Artery Disease (PAD)

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June 24, 2024 08:32 AM Eastern Daylight Time LOS ANGELES–(BUSINESS WIRE)–ChromaDex Corp. (NASDAQ:CDXC), the global authority on nicotinamide adenine dinucleotide (NAD+) research, shares results from a milestone phase II clinical study showcasing the promising effects of nicotinamide riboside (NR) supplementation for people with peripheral artery disease (PAD). This study was […]

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Microbot Medical Partners with Brigham and Women’s Hospital for Its Pivotal Human Clinical Trial

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Following FDA Approval to Commence the Clinical Trial, an Official Site Initiation Has Taken Place as Preparation for Patient Enrollment Advances Multiple Robotic Systems Already Received by the Site to Allow Inventory Readiness in Support of Trial BRAINTREE, Mass., June 20, 2024 (GLOBE NEWSWIRE) — Microbot Medical Inc. (Nasdaq: MBOT) announced its agreement with Brigham and Women’s Hospital (BWH), a leading academic medical center located in Boston, Massachusetts, to serve as one of the sites to perform the pivotal human clinical trial for its LIBERTY® Endovascular Robotic Surgical System, as part of its Investigational Device Exemption (“IDE”) application. This development, previously announced on June 17, 2024, follows the U.S. Food and Drug Administration’s approval to commence Microbot’s pivotal human clinical trial. The Company has completed the Site Initiation Visit, during which BWH clinical staff was trained on the clinical study protocols and the use of the LIBERTY® Endovascular Robotic Surgical System. In addition, the first shipment of LIBERTY investigational systems arrived at BWH this week in support of the clinical trial. Dr. Dmitry Rabkin, MD, PhD (Assistant Chief, Division of Angiography & Interventional Radiology), will lead the study for the site as principal investigator at BWH. “We are pleased to work with Dr. Rabkin and the team at Brigham and Women’s Hospital on this clinical study,” commented Harel Gadot, CEO, President and Chairman of Microbot Medical. “We believe their commitment to research and the advancement of science make them an ideal clinical study site.” The Company is in the process of engaging additional leading centers to participate in the clinical trial. About Microbot Medical Microbot Medical Inc. (NASDAQ: MBOT) is a clinical stage medical device company that specializes in transformational micro-robotic technologies, with the goals of improving clinical outcomes for patients and increasing accessibility through the natural and artificial lumens within the human body. The Investigational LIBERTY® Endovascular Robotic Surgical System aims to improve the way surgical robotics are being used in endovascular procedures today, by eliminating the need for large, cumbersome, and expensive capital equipment, while reducing radiation exposure and physician strain. The Company believes the LIBERTY® Endovascular Robotic Surgical System’s remote operation has the potential to be the first system to democratize endovascular interventional procedures. Further information about Microbot Medical is available at http://www.microbotmedical.com. Safe Harbor Statements to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for Microbot Medical Inc. and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects” and “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, market conditions, risks inherent in the development and/or commercialization of the LIBERTY® Endovascular Robotic Surgical System, the outcome of its studies to evaluate the LIBERTY® Endovascular Robotic Surgical System, uncertainty in the results of pre-clinical and clinical trials or regulatory pathways and regulatory approvals, including whether the Company’s pivotal study in humans is successful, any failure or inability to recruit physicians and clinicians to serve as primary investigators to conduct regulatory studies which could adversely affect or delay such studies, disruptions resulting from new and ongoing hostilities between Israel and the Palestinians and other neighboring countries, any lingering uncertainty resulting from the COVID-19 pandemic, need and ability to obtain future capital, and maintenance of intellectual property rights. Additional information on risks facing Microbot Medical can be found under the heading “Risk Factors” in Microbot Medical’s periodic reports filed with the Securities and Exchange Commission (SEC), which are available on the SEC’s web site at www.sec.gov. Microbot Medical disclaims any intent or obligation to update these forward-looking statements, except as required by law. Investor Contact:Michal EfratyIR@microbotmedical.com

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Micro Medical Solutions Achieves Milestone with 200th Enrollment in HEAL Registry

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Clinical investigators complete record enrollment in real-world Registry, HEAL (An All-comers Registry of the MicroStent PeripHeral Vascular StEnt in subjects with PeripherAl ArteriaL Disease)
WILMINGTON, Mass., June 18, 2024 /PRNewswire/ — Micro Medical Solutions — Micro Medical Solutions, a leader in providing innovative medical device solutions, is excited to announce that it has achieved a major milestone with the enrollment of its 200th patient in the HEAL Registry. This unique registry is focused on gathering real world evidence using its MicroStent technology for treatment of patients with Chronic Limb-Threatening Ischemia (CLTI) and Critical Limb Ischemia (CLI).
CLTI and CLI are debilitating conditions that affect the blood vessels in the legs and feet. Those afflicted with this disease often suffer from severe pain, numbness, and open non-healing wounds. Without intervention, these conditions can lead to amputation, loss of mobility, and death. Micro Medical Solutions is committed to providing a potential solution for this medically complex and underserved patient population.
The HEAL Registry, enrolling patients at ten sites in EU countries, including Italy, Germany, Belgium, Austria and the Netherlands, is crucial clinical research in evaluating the use of MMS’ MicroStent to treat real world patients afflicted with CLI/CLTI. HEAL’s research endpoints provide real world evidence of the effectiveness and safety of treatment with the Micro Stent. With enrollment of 200 patients, the registry has reached a significant clinical and research milestone. The registry is also collecting specific data outcomes in below-the-ankle treatment, specific to wound healing. This data will be reported alongside MMS’ US IDE study data to the FDA in its premarket approval application (PMA).
“We are proud to have created the largest real-world cohort of patients and data collection for an implanted stent below the knee in the HEAL Registry,” said Greg Sullivan, CEO of Micro Medical Solutions. “This milestone is a testament to our commitment to providing innovative solutions for those suffering from CLI/CLTI. We are optimistic about the encouraging data that has emerged from the registry and look forward to utilizing this information to continue providing effective treatment options.”
Micro Medical Solutions completed enrollment in its STAND IDE study, a Randomized Controlled Trial, in the US in December of 2023. MMS expects to share this data in early 2025. STAND reflects controlled patient selection with required follow up visits, HEAL reflects general CLI/CLTI patient population treated in everyday practice while including required follow-up. The combination of RCT and RWE data will provide physicians with the opportunity and confidence to make treatment decisions using evidence-based medicine.
MMS is dedicated to making a positive impact on the lives of those affected by this limb threatening disease and is committed to using real world data to support its mission to support physicians in their management of these patients.
Thank you to the physicians and patients for their continued support as we strive towards providing effective and innovative solutions for those in need.
About Micro Medical Solutions
For more about Micro Medical Solutions, visit www.micromedicalsolutions.net. 
SOURCE Micro Medical Solutions

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Cordis Announces Positive 24-Month Results from Superficial Femoral Artery Study, Confirming Sustained Benefits of SELUTION SLR™ (sustained limus release) Drug-Eluting Balloon in Complex Patients

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MIAMI LAKES, Fla., June 18, 2024 /PRNewswire/ — Cordis, a global leader in the development and manufacturing of interventional cardiovascular and endovascular technology, today announces positive 24-month results from the SELUTION SFA Japan Trial. The prospective, multi-center, single arm trial is designed to assess the safety and efficacy of SELUTION SLR™ Drug-Eluting Balloon (DEB) for the endovascular therapy of de novo and non-stented restenotic lesions in the superficial femoral artery (SFA) and the popliteal artery (PA). The findings were presented at the Japan Endovascular Treatment Conference (JET) 2024.

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“The SELUTION SLR™ DEB outcomes demonstrate patient benefits that are sustained out to 24 months and can match proven paclitaxel DCB performance in a complex patient population,” said Dr. Osamu Iida, Osaka Police Hospital Cardiovascular Division, Osaka, Japan. “These are promising results that build confidence in Limus drug-eluting balloons being a safe and effective option for SFA treatment while avoiding any paclitaxel related concerns.”

The long-term follow-up of SELUTION SLR™ DEB confirmed efficient sirolimus drug transfer and retention with safety and efficacy sustained through 24 months in a complex population that included 60.3% diabetics, mean lesion length of 127 mm, 17.2% total occlusions, and 47.8% involvement of the popliteal.
At 24 months, SELUTION SLR™ DEB delivered primary patency of 83.0% and CD-TLR of 95.4% achieving best in class efficacy results without compromise.
The SELUTION SFA Japan trial results demonstrate consistency of the SELUTION SLR™ DEB in being a safe and effective treatment option for femoropopliteal disease.

“The SELUTION SFA Japan trial continues to build confidence in the SELUTION SLR™ DEB technology. The SELUTION SLR™ DEB delivers some of the highest patency rates amongst SFA paclitaxel DCB studies and differentiates from other Limus-based devices. The ability to achieve durable clinical results in a challenging patient population provides clinicians a solution that will offer value to real world patients,” said George Adams, M.D. and Chief Medical Officer at Cordis. “We are excited for the evolution of patient care and to be leading that journey by expanding access to SELUTION SLR™ DEB.”Cordis is committed to generating coronary and peripheral clinical evidence that changes the standard of care. The SELUTION SFA Japan trial is one of the first of several large trials in the SELUTION SLR™ DEB clinical trial portfolio. Long term results validate previous clinical experience and builds confidence and excitement for data to come from four major randomized controlled trials and one real world registry data sets currently underway across coronary, superficial femoral artery and below the knee arteries.About SELUTION SLR ™ DEBSELUTION SLR™ DEB uses MicroReservoirs which contain a mixture of biodegradable polymer intermixed with the anti-restenotic drug sirolimus, applied as a coating on the surface of an angioplasty balloon. These MicroReservoirs are designed to provide controlled and sustained release of the drug. The proprietary CELL ADHERENT TECHNOLOGY (CAT)™ enables the MicroReservoirs to be coated onto balloons and efficiently transferred to adhere to the vessel lumen when delivered via expansion of the balloon.SELUTION SLR™ Drug-Eluting Balloon coronary, SFA, and BTK platforms are commercially available in Europe, the Middle East, and several markets across Asia and Latin America and most other countries where the CE mark is recognized.SELUTION SLR™ Drug-Eluting Balloon is investigational in the United States and not approved for sale or distribution.About CordisCordis is a global leader in the development and manufacturing of interventional cardiovascular and endovascular technologies. For over 60 years, we have remained committed to improving patients’ lives through innovation, enhanced clinical outcomes, education, and service. Our mission is to relentlessly pursue our dedication to transform cardiovascular care.For more information about Cordis, please visit www.cordis.com and follow Cordis on LinkedIn.Media Contact:Chris BinghamVice President, Global Market & Strategy[email protected]SOURCE Cordis

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ISTH 2024 Unveils Late-Breakthrough Abstracts to be Presented in Bangkok, Thailand Showcasing Groundbreaking Science and Research

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International scientific meeting convenes in Bangkok, Thailand, for the first time highlighting the important work of the Asian-Pacific scientific and clinical community
BANGKOK, June 17, 2024 /PRNewswire/ — Today, the International Society on Thrombosis and Haemostasis (ISTH) announces that all ISTH 2024 Congress (June 22-26, 2024) abstracts are available online, including late-breakthrough abstracts, to give a detailed glimpse into the posters, presentations and plenaries that will be presented at the Congress in Bangkok, Thailand.
At the ISTH 2024 Congress, thousands of the world’s leading experts on thrombosis, hemostasis and vascular biology will convene in Bangkok, Thailand, to present the most recent advances, exchange the latest science and discuss the newest clinical applications designed to improve patient care. This marks the Congress’s return to the Asia-Pacific region for the first time since it was held in Kyoto, Japan, in 2011, and its debut in Bangkok.
Through an extensive lineup of educational sessions, poster and oral communications, state-of-the-art lectures, medical industry exhibits and professional networking opportunities, the Congress promotes the latest scientific discourse and advancement in the field.
The following late-breakthrough abstracts will be highlighted during the ISTH 2024 Congress:

Evaluation of recombinant human prourokinase in the treatment of acute pulmonary embolism (ERUPTE): A randomized, single-blinded, multicenter, phase 2 trial, Zhi-Cheng Jing, Guangdong Provincial People’s Hospital, China
Efficacy and safety of Mim8 prophylaxis in adults and adolescents with hemophilia A with or without inhibitors: Phase 3, open-label, randomized, controlled FRONTIER2 study, Maria Elisa Mancuso, IRCCS Humanitas Research Hospital, Italy
EMA601, a novel humanised fab inhibits platelet Glycoprotein VI with unprecedented potency and protects mice from arterial thrombosis and ischemic stroke, Stefano Navarro, University of Würzburg, Germany

To see a full list of the late-breakthrough abstracts that will be presented throughout the Congress, continue reading below.
Sunday, June 23, 2024

Safety, tolerability, and efficacy of mezagitamab (TAK-079) in chronic or persistent primary immune thrombocytopenia: Interim results from a phase 2, randomized, double-blind, placebo-controlled study by David Kuter, Massachusetts General Hospital, United States – Late Breakthrough Session 1.1, 9:30 a.m., Plenary Hall
Engineering FVIII protein for enhancing expression and secretion profile to achieve normal level of FVIII in plasma utilizing noninvasive transcutaneous ultrasound mediated gene delivery by Ivan Krivega, SonoThera, United States – Late Breakthrough Session 1.2, 9:45 a.m., Plenary Hall
Evaluation of recombinant human prourokinase in the treatment of acute pulmonary embolism (ERUPTE): A randomized, single-blinded, multicenter, phase 2 trial, by Zhi-Cheng Jing, Guangdong Provincial People’s Hospital, China – Late Breakthrough Session 1.3, 10:00 a.m., Plenary Hall
EMA601, a novel humanised fab inhibits platelet glycoprotein VI with unprecedented potency and protects mice from arterial thrombosis and ischemic stroke, by Stefano Navarro, University of Würzburg, Germany – Late Breakthrough Session 1.4, 10:15 a.m., Plenary Hall
Efficacy and safety of Mim8 prophylaxis in adults and adolescents with hemophilia A with or without inhibitors: Phase 3, open-label, randomized, controlled FRONTIER2 study, by Maria Elisa Mancuso, IRCCS Humanitas Research Hospital, Italy – Late Breakthrough Session 1.5, 10:30 a.m., Plenary Hall

Due to limited space, the ISTH 2024 Congress will not hold a press conference this year.For more information about the ISTH 2024 Congress, visit www.isth2024.org and for all other media needs, visit the virtual press room: www.isth2024.org/pressroom
About the International Society on Thrombosis and Haemostasis (ISTH)  Founded in 1969, the ISTH is the leading worldwide not-for-profit organization dedicated to advancing the understanding, prevention, diagnosis, and treatment of conditions related to thrombosis and hemostasis. ISTH is an international medical-scientific professional membership organization with more than 7,000 clinicians, researchers, and educators working together to improve the lives of patients in more than 110 countries around the world. Among its highly regarded activities and initiatives are education and standardization programs, clinical and laboratory practice guidelines and guidance, research activities, meetings and congresses, peer-reviewed publications, expert committees, and World Thrombosis Day on 13 October. Visit ISTH online at www.isth.org. 
SOURCE International Society on Thrombosis and Haemostasis

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Microbot Medical Announces Brigham and Women’s Hospital as a Site for its Pivotal Human Clinical Trial

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BRAINTREE, Mass., June 17, 2024 (GLOBE NEWSWIRE) — Microbot Medical Inc. (Nasdaq: MBOT) today announces that Brigham and Women’s Hospital (BWH), a leading academic medical center located in Boston, Massachusetts, will participate as a clinical trial site for the pivotal human clinical trial as part of its Investigational Device Exemption (“IDE”) application for its LIBERTY® Endovascular Robotic Surgical System. Dr. Dmitry Rabkin, MD, PhD (Assistant Chief, Division of Angiography & Interventional Radiology) has been selected as principal investigator at BWH. “We are excited to participate in the clinical evaluation of this innovative technology,” said Dr. Rabkin. BWH has completed the Site Initiation Visit, during which BWH clinical staff was trained on the clinical study protocols. In addition, a shipment of LIBERTY investigational units arrived at BWH this week for the clinical trial. “We are pleased to work with Dr. Rabkin and the team at Brigham and Women’s Hospital on this clinical study.” commented Harel Gadot, CEO, President and Chairman of Microbot Medical. “We believe their commitment to research and the advancement of science make them an ideal clinical study site.” The Company is in the process of engaging additional leading centers to participate in the clinical trial. About Microbot Medical Microbot Medical Inc. (NASDAQ: MBOT) is a clinical- stage medical device company that specializes in transformational micro-robotic technologies, with the goals of improving clinical outcomes for patients and increasing accessibility through the natural and artificial lumens within the human body. The Investigational LIBERTY® Endovascular Robotic Surgical System aims to improve the way surgical robotics are being used in endovascular procedures today, by eliminating the need for large, cumbersome, and expensive capital equipment, while reducing radiation exposure and physician strain. The Company believes the LIBERTY® Endovascular Robotic Surgical System’s remote operation has the potential to be the first system to democratize endovascular interventional procedures. Further information about Microbot Medical is available at http://www.microbotmedical.com. Safe Harbor Statements to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for Microbot Medical Inc. and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects” and “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, market conditions, risks inherent in the development and/or commercialization of the LIBERTY® Endovascular Robotic Surgical System, the outcome of its studies to evaluate the LIBERTY® Endovascular Robotic Surgical System, uncertainty in the results of pre-clinical and clinical trials or regulatory pathways and regulatory approvals, including whether the Company’s pivotal study in humans is successful, any failure or inability to recruit physicians and clinicians to serve as primary investigators to conduct regulatory studies which could adversely affect or delay such studies, disruptions resulting from new and ongoing hostilities between Israel and the Palestinians and other neighboring countries, any lingering uncertainty resulting from the COVID-19 pandemic, need and ability to obtain future capital, and maintenance of intellectual property rights. Additional information on risks facing Microbot Medical can be found under the heading “Risk Factors” in Microbot Medical’s periodic reports filed with the Securities and Exchange Commission (SEC), which are available on the SEC’s web site at www.sec.gov. Microbot Medical disclaims any intent or obligation to update these forward-looking statements, except as required by law. Investor Contact: Michal Efraty IR@microbotmedical.com

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New FDA Cleared Balloon Catheter Used for Vessel Occlusion During Patient Resuscitation

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Temporary vessel occlusion a growing practice for trauma patients.
SALT LAKE CITY, June 13, 2024 /PRNewswire/ — Emergency Scientific, a Utah-based medical device company specializing in innovative solutions for the emergency medicine industry, has announced the first patient use of its Landmark REBOA Catheter. The Landmark Catheter was developed for resuscitative endovascular occlusion of the aorta (REBOA), a procedure developed by the military to treat hemorrhage from non-compressible fractures of the pelvis and penetrating trauma of the abdomen and has since been adopted by civilian providers.
REBOA is also used for postpartum hemorrhage (PPH), cardiac arrest (CA), abdominal aortic aneurysm (AAA) ruptures, and gastrointestinal (GI) bleeds.
“Landmark was easy to use and easy to deliver with a smooth insertion,” said Scott T. Youngquist, MD, MS, FACEP, FAEMS, FAHA, an emergency medicine physician at the University of Utah who performed the first case. “REBOA can be an important tool to aid in patient resuscitation.” It is estimated that more than 60,000 people die every year in the United States from traumatic hemorrhage, making it the number one cause of death in patients under 45 years old.1,2
“We are pleased to offer another solution for physicians to treat challenging emergency hemorrhage,” said Ryan Murri, Emergency Scientific’s Chief Executive Officer. “With high quality emergency medicine solutions, we hope to be able to save more patients suffering life threatening injuries. We believe nobody should die from the loss of blood who could be saved with the right tools, and we look forward to continuing to serve our healthcare partners with additional novel treatment options.”
The Landmark REBOA Catheter recently received FDA 510(k) clearance and is indicated for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.
Emergency Scientific is a privately held company engaged in the development, manufacturing, and distribution of novel emergency medicine solutions.

Latif, R.K., Clifford, S.P., Baker, J.A. et al. Traumatic hemorrhage and chain of survival. Scand J Trauma Resusc Emerg Med 31, 25 (2023). 
Kauvar, David S. MD; Lefering, Rolf PhD; Wade, Charles E. PhD. Impact of Hemorrhage on Trauma Outcome: An Overview of Epidemiology, Clinical Presentations, and Therapeutic Considerations. The Journal of Trauma: Injury, Infection, and Critical Care 60(6):p S3-S11, June 2006.

SOURCE Emergency Scientific

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Xeltis receives IDE approval from FDA for initiation of US pivotal trial for aXess™, its restorative vascular access conduit

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aXess is a restorative arteriovenous dialysis conduit which allows vascular access for hemodialysis through the creation of a new, permanent, living vessel

EINDHOVEN, The Netherlands, June 13, 2024 /PRNewswire/ — Xeltis, a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels, announces that it has gained approval from the US Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) submission to begin enrolling patients into a pivotal study for aXess.
aXess is a restorative conduit that enables the creation of a new, permanent, living vessel for hemodialysis vascular access, combining the safety and patency of an arteriovenous fistula (AVF), with the speed to treatment of an arteriovenous graft (AVG). The aXess vascular access conduit offers an improved dialysis patient experience and avoids the frequent reinterventions and complications, such as infections, faced by many renal disease patients.
Xeltis’ groundbreaking implants platform is an important development in vascular replacement technology as, over time, its implants are gradually replaced by the patients’ own living healthy tissue. Xeltis’ novel technology has already treated over 100 patients across different clinical trials.   
Eliane Schutte, Chief Executive Officer, Xeltis commented: “We have already shown outstanding 12-month data from our first-in-human study in Europe and are looking forward to starting this pivotal trial in the US. We are very proud of the potential for aXess to transform the field of vascular access by stopping the cycle of interventions and infections and bringing our unique restorative solution to hemodialysis patients worldwide.”
Paulo Neves, Chief Medical Officer, Xeltis said: “Our focus is on improving the outcomes for patients on dialysis. aXess offers this potential through its avoidance of the reinterventions and complications associated with other vascular access solutions. This pivotal study is important in assessing and demonstrating this and marks a significant milestone in our clinical strategy in the US.”
The US-based pivotal trial follows strong 12-month data from the first-in-human trial in Europe in comparison to hemodialysis vascular access solutions. aXess is also undergoing an EU pivotal trial, recruiting up to 110 patients in nine EU countries.
About XeltisXeltis is a medtech company developing transformative implants that enable the natural creation of living and long-lasting vessels. Xeltis seeks to address the limitations of currently available options for the millions of people requiring hemodialysis access grafts or cardiovascular replacements every year. The Company’s proprietary endogenous tissue restoration (ETR) platform utilizes an advanced polymer implant which regenerates the patient’s own tissue before gradually being absorbed and leaving new, living, and long-lasting vessels in place. Xeltis’ most advanced product currently under clinical development is aXess™, an implantable blood vessel for hemodialysis vascular access. Xeltis’ groundbreaking technology has high potential to be applied to other major vascular and cardiovascular diseases. 
Xeltis is based in The Netherlands and the USA. Its investors include DaVita Venture Group, EQT Life Sciences, Kurma Partners, VI Partners, Ysios Capital, Grand Pharma Group, the European Innovation Council and Invest-NL, in addition to other public and private investors.
About aXessaXess is a restorative conduit which enables the creation of a new, permanent, living vessel for hemodialysis vascular access. It combines the safety and patency of a fistula with the speed to treatment of an AV graft. The aXess vascular access conduit offers an improved dialysis patient experience and avoids the frequent reinterventions and complications, such as infections, faced by renal disease patients.
A first-in-human trial of aXess demonstrated a significant improvement in performance compared to hemodialysis vascular access solutions. A pivotal trial of aXess is currently enrolling up to 110 patients in nine EU countries.
Go to axesspivotal.com for more details.
SOURCE Xeltis

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Surmodics Awarded Thrombectomy Products Agreement with Premier, Inc.

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EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies, today announced it has been awarded a group purchasing agreement for thrombectomy products with Premier, Inc. Effective June 1, 2024, the new agreement allows Premier members, at their discretion, to take advantage […]

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