Peripheral/Endo

FDA Grants R3 Vascular IDE Approval for ELITE-BTK Pivotal Trial of its MAGNITUDE® Drug Eluting Next Generation Bioresorbable Scaffold for Below-the-Knee Peripheral Arterial Disease

MOUNTAIN VIEW, Calif., Nov. 04, 2024 (GLOBE NEWSWIRE) — R3 Vascular Inc., a medical device company dedicated to developing and providing novel, best-in-class bioresorbable scaffolds for treating peripheral arterial disease (PAD), is pleased to announce that the U.S. Food and Drug Administration (FDA) granted investigational device exemption (IDE) approval to initiate its ELITE-BTK pivotal trial of its next generation drug eluting bioresorbable scaffold, MAGNITUDE®, for below-the-knee (BTK) PAD. 

Surmodics Announces Early Results from PROWL Registry Study of Real-World Limb Ischemia Patients Treated with Pounce™ Thrombectomy System

EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced that early results of a subset of 60 real-world acute, subacute, and chronic limb ischemia patients from its PROWL registry study were presented by Dr. […]

Jupiter Endovascular Announces First U.S. Patient Treated With Vertex Pulmonary Embolectomy System Using Endoportal Control

MENLO PARK, Calif.–(BUSINESS WIRE)–Jupiter Endovascular, Inc., a medical technology startup developing a new class of endovascular procedures using Endoportal Control™, announced today that the first U.S. patient has been treated in the SPIRARE II U.S. pivotal study of the Vertex Pulmonary Embolectomy System featuring the company’s Endoportal Control™ platform technology. […]

CorMedix Inc. Announces New Data at ASN Kidney Week 2024

Study highlights significant healthcare challenges and costs associated with bloodstream infections (BSIs) in patients receiving chronic hemodialysis through central venous catheters (HD-CVCs) Study highlights significant healthcare challenges and costs associated with bloodstream infections (BSIs) in patients receiving chronic hemodialysis through central venous catheters (HD-CVCs)

Flosonics Medical Earns Best In Class Digital Health Award for World’s First Wearable Doppler Ultrasound Patch

LAS VEGAS–(BUSINESS WIRE)–Flosonics Medical, a leader in wearable medical ultrasound, was selected as a Best in Class of the Digital Health Awards, presented by the Digital Health Hub Foundation in a ceremony Monday afternoon in Las Vegas at HLTH, the global healthcare conference. “We are thrilled to be selected as a […]

VS Enrolls First Patient in U.S. Pivotal Intravascular Lithotripsy Study POWER PAD II IDE trial will evaluate safety and efficacy of the Pulse IVL™ system in patients with severely calcified peripheral arterial disease

October 15, 2024 07:58 AM Eastern Daylight Time BOSTON–(BUSINESS WIRE)–Amplitude Vascular Systems (AVS), a medical device company focused on safely and effectively treating severely calcified arterial disease, announced today that it has enrolled the first patient(s) in its U.S. pivotal trial for Pulsatile Intravascular Lithotripsy (PIVL) therapy. The POWER PAD […]

Inari Medical Announces Partnership with AVF and NBCA on DEFIANCE Trial

IRVINE, Calif., Oct. 15, 2024 (GLOBE NEWSWIRE) — In recognition of World Thrombosis Day, Inari Medical, Inc. (NASDAQ: NARI) (“Inari”) a medical device company with a mission to treat and transform the lives of patients suffering from venous and other diseases, today announced collaborative partnerships with the American Venous Forum (“AVF”) and the National Blood Clot Alliance (“NBCA”) on the DEFIANCE trial. This prospective, multinational, randomized controlled trial (“RCT”) will evaluate and compare clinical outcomes in patients with deep vein thrombosis (“DVT”) treated with Inari’s ClotTriever System versus anticoagulation alone.

Humacyte Late-Breaking Abstract Accepted for Oral Presentation on V007 Phase 3 AV Access Clinical Trial at the American Society of Nephrology’s Kidney Week 2024

DURHAM, N.C., Oct. 08, 2024 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced that its late-breaking abstract on the V007 Phase 3 clinical trial of the acellular tissue engineered vessel (ATEV™) in arteriovenous access for patients with end-stage renal disease was accepted for an oral presentation at the American Society of Nephrology’s (ASN) Kidney Week 2024. The late-breaking abstract titled “Prospective Randomized Trial of Humacyte’s Acellular Tissue Engineered Vessel Versus Autologous Arteriovenous Fistula for Hemodialysis Access” will be presented at the ASN meeting in San Diego on October 26, 2024.