Peripheral/Endo

Terumo Medical Corporation’s New AZUR HydroPack™ Peripheral Coil System Provides a Soft-Packing, Long-Lasting Solution to Embolotherapy

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– Enhances a comprehensive platform of AZUR™ hydrogel technologies with versatile and reliable packing for embolization –
SOMERSET, N.J., Dec. 11, 2023 /PRNewswire/ — Terumo Medical Corporation is pleased to announce the launch of its new AZUR HydroPack Peripheral Coil System in the United States. The AZUR HydroPack Coil System is a soft, universal-shaped platinum and hydrogel coil designed to find and fill empty space within the vessel. It is also the only packing coil to use proprietary designed hydrogel technology to create a gel core for mechanical occlusion, a unique feature of AZUR peripheral coils.[1] Terumo received Food and Drug Administration clearance for the AZUR HydroPack Coil System earlier this year; it is fully available starting today.
“The AZUR HydroPack Peripheral Coil System provides optimized stability and precise delivery. Its versatility and efficiency provide interventional radiologists and vascular surgeons with an ideal solution to ensure the best possible outcome for patients,” said Chris Pearson, Executive Vice President, Terumo Interventional Systems (TIS) – North America. “Its state-of-the-art design and uniform microcatheter compatibility set it apart from other packing coils. This is important as the market for peripheral coil embolization expands and diversifies.”
The AZUR HydroPack Peripheral Coil System has a true .018″ primary wind and is available in long lengths – ranging from 5 to 60 cm – making it the longest gel core coil on the market.[1] It allows for flexible sizing and can be deployed through 2.4Fr or 2.8Fr microcatheters in a single-coil platform. With no requirements for vessel-diameter sizing other than placement of an anchor coil, this may reduce the amount of inventory required to support a wide variety of peripheral embolization procedures.[1] The soft coil design paired with an enhanced pusher allows for ease of delivery, optimized trackability and microcatheter stability.[1]
“Our unique hydrogel technology is a key differentiator as it creates a gel core and promotes new tissue growth versus the basic thrombogenic response of a traditional platinum coil. It also will allow physicians to fill open vessel space confidently and efficiently while minimizing reperfusion,” said Michael J. Martinelli, MD, FACC, FSCAI and Chief Medical Officer, Terumo Medical Corporation. “Additionally, the tight packing and durable occlusion associated with hydrogel technology put the AZUR HydroPack Coil System in a category of its own in the peripheral coil market.”
The AZUR HydroPack Peripheral Coil System – the latest addition to the TIS embolotherapy portfolio – is designed to fill volume behind the Terumo AZUR™ CX Peripheral Coil System for vessel occlusion and to fill volume inside of the AZUR™ Framing Coil System for aneurysm occlusion. To learn more about the AZUR HydroPack Peripheral Coil System, click here: https://bit.ly/47VVAQZ.

[1] Data on file

About Terumo Interventional Systems
Terumo Interventional Systems (TIS), a division of Terumo Corporation, is a market leader in minimally invasive entry site management, lesion access, and interventional technologies. TIS offers a complete, solution-based product portfolio used in advanced coronary, peripheral and endovascular treatments with strategic initiatives in Transradial Access, Complex Coronary Intervention, Peripheral Artery Disease and Embolotherapy.  TIS combines innovative research and development with a deep market understanding to create a pipeline of industry-leading devices that deliver clinical value, economic benefit, and enhanced patient outcomes.
About Terumo Medical Corporation
Terumo Medical Corporation (TMC) is a subsidiary of Terumo Corporation, founded in 1972 as the United States expansion of our larger Tokyo-based parent. For over 50 years, TMC has continued the Terumo mission of offering the best possible solutions to healthcare providers and the people they serve. TMC provides products and services across four divisions: Terumo Health Outcomes (THO), which provides healthcare systems with solutions designed to reduce care variation, improve quality metrics, minimize cost and maximize revenue; Terumo Interventional Systems (TIS), which offers solutions for entry site management and lesion access; Terumo Medical Products (TMP), which provides devices for injection and infusion therapy; and Terumo Pharmaceutical Solutions (TPS), which develops drug delivery devices.
About Terumo
Terumo (TSE:4543) is a global leader in medical technology and has been committed to “Contributing to Society through Healthcare” for over 100 years. Based in Tokyo and operating globally, Terumo employs more than 30,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice such as transfusion systems, diabetes care, and peritoneal dialysis treatments. Terumo will further strive to be of value to patients, medical professionals, and society at large. More information can be found at www.terumo.com.
SOURCE Terumo Medical Corporation

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BioGenCell Announces the Launch of BioGenCell’s Fifth Chronic Limb-Threatening Ischemia Clinical Trial Site in the United States

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BioGenCell has announced the inauguration of the fifth Phase II cell-therapy-based clinical trial site for Chronic Limb-Threatening Ischemia (CLTI) in the United States at the University of Maryland Medical Center. This initiative is committed to dramatically reducing the incidence of amputations in patients afflicted with severe CLTI.
BALTIMORE, Md, Dec. 7, 2023 /PRNewswire/ — BioGenCell, a pioneer in personalized cell therapy solutions, is excited to announce the launch of its fifth Phase II clinical trial site in the United States at the University of Maryland Medical Center. The trial is focused on significantly reducing the need for amputation in patients with Chronic Limb-Threatening Ischemia (CLTI). The University of Maryland Medical Center has joined this ambitious, global, placebo-controlled trial designed to offer transformative results for patients.
The prognosis for CLI patients is currently disheartening: within a year of diagnosis, nearly 20% of patients succumb to the disease while 30% will undergo amputation. Tragically, nearly 70% of these amputees do not survive beyond five years post-amputation.
BioGenCell’s innovative yet low-risk technology harnesses the immune, stem, and progenitor cells from the patient’s own blood, drawn in a simple procedure. Upon reinjection into the affected limb, these “trained” cells stimulate the formation of new, healthy blood vessels, restoring blood flow, potentially averting limb amputation or even death, and significantly enhancing patient quality of life. BioGenCell’s previous clinical trial revealed an encouraging long-term amputation-free survival rate.
“We’re thrilled to embark on this journey with a significant institution like the University of Maryland,” said Dr. Yael Porat, BioGenCell co-founder and CEO. “Our aim is to bring tangible relief to individuals who have been living with CLI.”
Patients living with CLTI, their friends and relatives and interested physicians, are encouraged to visit www.biogencelltrial.com or reach out to the Study Coordinator (details) for more information on participating in this clinical trial.
About BioGenCell
BioGenCell, based at Laniado Hospital in Netanya, Israel, is dedicated to improving the lives of patients suffering from degenerative microvascular diseases. BioGenCell aims to extend its reach to address a wider range of vascular and other diseases in the future. For more information, please visit https://www.biogencell.net.
For more info:
Ifat Shomrony I [email protected] I +972-52-874-3030
SOURCE BioGenCell

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Micro Medical Solutions Announces Completion of Enrollment in the STAND Pivotal Clinical Trial

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Clinical investigators complete enrollment in the 177 patient, randomized, controlled study, STAND (A Clinical Evaluation of the MicroSTent PeripherAl Vascular SteNt in subjects with Arterial Disease Below the Knee, NCT03477604).
WILMINGTON, Mass., Dec. 6, 2023 /PRNewswire/ — Micro Medical Solutions (MMS), an innovator in the field of microvascular intervention to improve clinical outcomes and quality of life in patients with CLI/CLTI, announced today that it has completed its U.S. pivotal clinical study enrollment evaluating the safety and effectiveness of the MicroStent System compared to the current standard of care, PTA (percutaneous transluminal angioplasty). The MicroStent System has already obtained CE Mark approval for use in the EEA.
STAND (A Clinical Evaluation of the MicroSTent PeripherAl Vascular SteNt in subjects with Arterial Disease Below the Knee) enrolled its final patient earlier this month marking the completion of the study. MicroStent is a vascular stent specifically designed to achieve and maintain tibioperoneal arterial patency improving blood flow and wound healing for below-the-knee amputation reduction in patients with critical limb ischemia (CLI) resulting from progressive peripheral artery disease (PAD). 
“I would like to thank the investigators and the research teams for their dedication, participation, collaboration and tremendous effort to help this complex and difficult patient population. I’m excited to continue to provide research expertise to the company and discuss the study results when available,” said lead investigator, Dr. Robert E. Beasley of Palm Vascular Centers in Miami Beach, Florida.
“CLI/CTI is the most severe clinical manifestation of PAD. We are excited to see the data unfold to further understand the impact of angiosome directed endovascular intervention and its impact on wound healing, limb salvage and patient living independence. We are warmly appreciative to our patient population that participated in the study. The study’s goal has always been to demonstrate a lower amputation rate thereby, lowering the devastating mortality rate associated with limb loss,” commented Rita Jacob, Vice President of Clinical Affairs.
“This is an encouraging step forward for MMS, millions of patients battling CLI every day and Clinicians treating and caring for these patients,” said CEO, Gregory Sullivan. “MMS developed the MicroStent platform in response to patients’ needs, and we are excited to move closer to putting MicroStent in the hands of U.S. interventionalists treating CLI.”
For more about Micro Medical Solutions, visit www.micromedicalsolutions.net.
SOURCE Micro Medical Solutions

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VESTECK, invited to present at the 16th Annual Greenberg Stent Summit, Boston, MA

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WEST CHESTER, Pa., Dec. 4, 2023 /PRNewswire/ — The VESTECK, Inc. Chief Technology Officer, invited to present the “SUTURE-TIGHT”™ technology at the 16th Annual Greenberg Stent Summit, sponsored by Mass General Brigham.
Stent Summit organizers requested Ted Wulfman, VESTECK, Inc. Chief Technology Officer, join in and stimulate the discussion on “There’s more to aneurysm treatment than the use of an endograft. What are the roles of adjunctive treatments in aneurysm treatment?” Tuesday 12/5/2023 10:56-11:17AM.
The 16th Greenberg Stent Summit brings together clinicians, members of the FDA and industry notables to create two and a half days of lively discussion on advances in aortic disease repair.
Mr. Wulfman commented, “I am honored to say the least. To receive an invitation to participate at such a prestigious conference as the Greenberg Stent Summit is a true honor. Two weeks ago, Prof. Krievins presented “SUTURE-TIGHT” at the iconic Veith meeting and now we are contributing to the conversation at the Boston Stent Summit. Very exciting stuff.”
“The positive momentum continues at VESTECK. We appreciate the podium presence. 9 clinical cases successfully completed. Patients are doing well. 3 new patents have been filed. We are headed to Australia, conducting clinical cases with Professors Ramon Varcoe and Andrew Holden, helping more moms, dads, brothers and sisters,” said VESTECK CEO, Joe Rafferty.
About VESTECK, Inc. (WWW.VESTECK.com) is a clinical stage medical device company focused on bringing a platform technology to the aortic repair, structural heart, peripheral vascular markets. The “SUTURE-TIGHT”™ catheter comes preloaded with 4 pair of nitinol sutures, it secures EVAR/TEVAR grafts to the aorta on initial implant or during repair procedures. “SUTURE-TIGHT”™ brings a simple, easy to use technology to physicians, patients and payors.
VESTECK is raising a $16M Series B round to support a clinical trial for FDA 510K clearance.
The VESTECK, Inc. “SUTURE-TIGHT”™ is not commercially available in the USA or OUS. 
MEDIA CONTACTS: VESTECK CEO, Joe Rafferty, [email protected] 
Please note that this document reflects statements that may constitute forward-looking statements and projections that are subject to risks and uncertainties, including information about possible or assumed future events, results of economic conditions and VESTECK’s business, results of operations, plans and objectives. These statements are based on management’s beliefs, assumptions and expectations of VESTECK’s future performance, taking into account information currently available to it. You should not place undue reliance on such statements, as new risks and uncertainties may arise and it is not possible for management to predict those events or how they may affect VESTECK, Inc.
SOURCE VESTECK, Inc.

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Roivios® announces final patient enrollment in feasibility trial for JuxtaFlow® Renal Assist Device (RAD)

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ROSWELL, Ga., Dec. 4, 2023 /PRNewswire/ — Roivios Ltd., a medical device company pioneering a revolutionary treatment to reduce poor surgical outcomes associated with Acute Kidney Injury (AKI), today announces that the final patient has been enrolled in the BIPASS-AKI study for the JuxtaFlow Renal Assist Device (RAD). The Institute of Cardiovascular Diseases, Sremska Kamenica in Serbia was the highest enrolling site, led by principal investigator Prof Dr Milovan Petrovic, cardiac surgeon Prof Dr Lazar Velicki and urologist Dr Dimitrije Jeremic. Additional study sites include The American Heart Hospital in Bielsko Biala, Poland and The Institute for Cardiovascular Diseases Dedinje, Serbia.
“When we began this feasibility trial, we anticipated the use of the JuxtaFlow RAD to be an exciting moment,” said Prof. Petrovic. “We frequently perform cardiac surgery on patients with renal impairment and they are among our most complicated cases, so we are proud to have enrolled several patients into this study to contribute insights into this novel therapy in advance of its pivotal trial.”
Cardiac surgery-associated AKI (CSA-AKI) occurs in up to 73% of patients who have pre-existing renal insufficiency documented as part of their standard pre-surgical workup1. This type of AKI then impacts a patient’s ability to recover from surgery, leading to a longer and more costly hospital stay, a higher risk of morbidity and mortality, and a more frequent need for chronic dialysis treatment2-5. The JuxtaFlow RAD is used in the hospital setting and is designed to enable the kidneys to function optimally and thereby improve overall patient outcomes.
“The mission of Roivios is to give clinicians the tools to protect, preserve and improve kidney function. Cardiac surgery is a major stress on the kidneys, and today these patients have few options. Our team is inspired to design a system that would assist critical renal function during times of acute stress, employing an innovative solution that enhances the kidneys’ own natural function to support recovery.”, said John Erbey, PhD, Chief Executive Officer of Roivios. “We are incredibly excited to have completed the first step in providing this novel therapy for at-risk patients and serve as the bridge to their successful recovery. We look forward to sharing this BIPASS-AKI data shortly and then continuing to partner with hospitals, surgeons, and critical care teams around the world who share our vision for reducing this all-too-frequent adverse event of surgery.”
The BIPASS-AKI feasibility trial was being conducted pursuant to the regulations of both ALIMS in Serbia and URPL in Poland. Ten patients were enrolled between September and December.
The JuxtaFlow RAD is not commercially available in any geography. The system is limited by United States law to Investigational Use Only and is not available for sale in the United States.
For more information about the JuxtaFlow RAD system, please visit www.roivios.comFor more information about BIPASS-AKI, see https://clinicaltrials.gov/study/NCT05990660
ContactJohn Erbey, PhD, Chief Executive Officer[email protected]

Shen W, Aguilar R, Montero AR, et al. Acute Kidney Injury and In-Hospital Mortality after Coronary Artery Bypass Graft versus Percutaneous Coronary Intervention: A Nationwide Study. Am J Nephrol. 2017;45(3):217-225.
Bowdish ME, D’Agostino RS, Thourani VH, et al. STS Adult Cardiac Surgery Database: 2021 Update on Outcomes, Quality, and Research. Ann Thorac Surg. 2021;111(6):1770-1780.
Robert AM, Kramer RS, Dacey LJ, et al. Cardiac surgery-associated acute kidney injury: a comparison of two consensus criteria. Ann Thorac Surg. 2010;90(6):1939-1943.
Palomba H, de Castro I, Neto AL, Lage S, Yu L. Acute kidney injury prediction following elective cardiac surgery: AKICS Score. Kidney Int. 2007;72(5):624-631.
Brown JR, Kramer RS, Coca SG, Parikh CR. Duration of acute kidney injury impacts long-term survival after cardiac surgery. Ann Thorac Surg. 2010;90(4):1142-1148.

About Roivios
Roivios® is a medical device company pioneering a novel renal assist device designed to reduce or eliminate acute kidney injury (AKI) in patients who are at elevated risk.
Initially focused on meeting an unmet need of cardiac surgery associated-acute kidney injury (CSA-AKI) in the coronary artery bypass and surgical valve population, our pioneering renal assist device has the potential to address a range of poor outcomes.
Our first product, the JuxtaFlow Renal Assist Device, is the world’s first negative pressure renal assist device, featuring a patented catheter and unique energy delivery system.
SOURCE Roivios, ltd

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Humacyte Announces Two Presentations at the VEITHsymposium® of Positive Clinical Results of the Human Acellular Vessel™ (HAV™) in the Treatment of Vascular Trauma

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DURHAM, N.C., Nov. 17, 2023 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced the presentation of positive V005 Phase 2/3 clinical trial results of the investigational Human Acellular Vessel (HAV) in the treatment of vascular trauma, […]

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Endologix Announces Results of Pooled Analysis of DETOUR1 and DETOUR2 Studies at 2023 VIVA Late-Breaking Clinical Trial Session

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IRVINE, Calif.–(BUSINESS WIRE)–Endologix LLC, a privately held, global medical device company dedicated to providing disruptive therapies for the interventional treatment of vascular disease, today announced results from a pooled analysis of DETOUR1 and DETOUR2 Studies evaluating Percutaneous Transmural Arterial Bypass (PTAB) with the DETOUR System. PTAB with the DETOUR System offers a novel approach to treating complex PAD, enabling physicians to bypass lesions in the superficial femoral art

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