Peripheral/Endo

Nectero Medical Announces Initiation of Phase II/III Clinical Trial of the Nectero EAST® System for Treatment of Small- to Medium-Sized Abdominal Aortic Aneurysms

TEMPE, Ariz.–(BUSINESS WIRE)– #AbdominalAorticAneurysm–Nectero Medical, a clinical-stage biotechnology company pioneering novel therapies to treat aneurysmal disease and improve patients’ lives, today announced initiation of a Phase II/III clinical trial (stAAAble) to investigate the safety and efficacy of the Nectero Endovascular Aneurysm Stabilization Treatment (Nectero EAST®) System in patients with infrarenal abdominal aortic aneurysms (AAAs), maximum diameter 3.5 – 5.0cm. The Nectero EAST System is a single-use,

Reflow Medical Receives CE Mark for Bare Temporary Spur Stent System for Treating de novo or Restenotic Below-the-Knee (BTK) Lesions

San Clemente, CA—Jan. 15, 2024 – Reflow Medical, Inc., a developer of innovative medical devices focused on cardiovascular disease, announces it has received CE (Conformité Européenne) Mark certification in the European Union for the Bare Temporary Spur Stent System. The device is intended to treat de novo or restenotic lesions […]

Multidisciplinary panel of experts from prominent cardiovascular societies advocate for broader adoption of IVUS in peripheral interventions to improve patient care

Amsterdam, the Netherlands – Royal Philips, a global leader in health technology, today announced that a group of multidisciplinary cardiovascular specialists from prominent medical societies have issued a joint expert opinion on the advantages of intravascular ultrasound (IVUS) use in peripheral arterial and deep venous interventions compared with using angiography alone. […]

Endovascular Engineering’s Hēlo™ Thrombectomy System Receives IDE Approval to Start ENGULF Pivotal Trial for the Treatment of Pulmonary Embolism

MENLO PARK, Calif., Jan. 11, 2024 /PRNewswire/ — Endovascular Engineering (“E2”), a medical device company focused on the development and deployment of groundbreaking clot removal technologies that target venous thromboembolism (VTE), announced today FDA Investigational Device Exemption…

Microbot Medical and Corewell Health Forge Collaboration to Establish the LIBERTY® Endovascular Robotic Surgical System for Telerobotic

BRAINTREE, Mass., Dec. 14, 2023 (GLOBE NEWSWIRE) — Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announced it has entered into a collaboration agreement with Corewell Health™. The objective of the collaboration, which will take place in multiple phases, is to enable telerobotics […]

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

– 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

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

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

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

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