Peripheral/Endo

BlackSwan Vascular Wins FDA Premarket Approval of Innovative New Treatment for Peripheral Arterial Hemorrhages

Lava® LES is the first liquid embolic product approved by the FDA for use in the peripheral vasculature HAYWARD, Calif., April 18, 2023 /PRNewswire/ — Bay Area-based BlackSwan Vascular, Inc., a privately held company that is developing innovative therapies in endovascular embolization, is pleased to announce it has received FDA Premarket Approval […]

Landmark New England Journal of Medicine Publication Reports Positive Results From PROMISE II Pivotal Trial Showing that LimFlow System Saves Most Patients with End-stage Peripheral Artery Disease From Major Amputation

PROMISE II Trial Met Primary Endpoint Therapy Demonstrates 76% Limb Salvage in Patients with Chronic Limb-Threatening Ischemia Who Otherwise Faced Amputation PARIS–(BUSINESS WIRE)–LimFlow SA, a pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), announced today […]

Surmodics Provides Regulatory Update on its Strategy to Submit an Amended Premarket Approval Application for the SurVeil™ Drug-Coated Balloon

Announces Receipt of Positive Formal FDA Feedback via the Q-Submission Program Substantially reduces the anticipated time and cost needed to receive a PMA 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 it has […]

GORE ANNOUNCES FIRST U.S. ENROLLMENT FOR THE GORE® VIAFORT VASCULAR STENT IVC STUDY

CAUTION: Investigational device. Limited by United States law to investigational use. FIRST U.S. PATIENT ENROLLED IN GORE® VIAFORT Vascular Stent pivotal study FLAGSTAFF, Ariz., March 28, 2023 /PRNewswire/ — W. L. Gore & Associates (Gore) has announced that the first U.S. patient has been enrolled in a prospective, non-randomized, multicenter, single-arm study with 5-year […]

Getinge recieves FDA premarket approval for the iCast™ covered stent system in the US

GOTHENBURG, Sweden, March 24, 2023 /PRNewswire/ — Getinge’s iCast™ covered stent system has received premarket approval from the U.S. Food and Drug Administration (FDA) for the treatment of patients with iliac arterial occlusive disease. Iliac arterial occlusive disease is a type of peripheral arterial disease (PAD), a serious condition that only in the US […]

Viz.ai is First to Receive FDA 510(k) Clearance for AI Algorithm for Abdominal Aortic Aneurysm

New artificial intelligence algorithm flags and triages suspected abdominal aortic aneurysms SAN FRANCISCO – March 21, 2023-  Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced it has received U.S. Food and Drug Administration (FDA) clearance for its algorithm intended to detect suspected abdominal aortic aneurysm […]

Merit Medical Launches Expanded SwiftNINJA® Steerable Microcatheter Offering

New sizes of advanced articulating microcatheter enhance a market-leading portfolio of vascular access products SOUTH JORDAN, Utah, March 20, 2023 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global manufacturer and marketer of healthcare technology, today announced the expansion of its SwiftNINJA Steerable Microcatheter product line. New […]

Embolx Signs International Distribution Agreement

SUNNYVALE, Calif., March 16, 2023 /PRNewswire/ — Embolx, Inc. – a medical device company developing microcatheters for arterial embolization procedures, today announced the signing of a distribution agreement with Cardiva Italia SRL. The partnership is expected to add great value to Embolx’s impressive network of distribution partners across Europe. Cardiva Italia will distribute […]

Microbot Medical Launches Presence in the United Kingdom as Highly Accomplished Consultant Interventional Radiologist Professor Mark W. Little Joins its Scientific Advisory Board as Efforts to Commercialize the LIBERTY® Robotic System Continue to Accelerate

Internationally Recognized Academic Leader Awarded the National Institute for Health Research (NIHR) Research Rising Star Award, and Cardiovascular and Interventional Radiology (CVIR) Editors Medal HINGHAM, Mass., March 16, 2023 (GLOBE NEWSWIRE) — Microbot Medical Inc. (Nasdaq: MBOT), which is rapidly scaling up its internal capabilities with globally renowned members joining […]

Shockwave Medical Announces U.S. Launch of New Peripheral IVL Catheter

Shockwave L⁶ Provides Physicians with Larger-Diameter Catheters to Expand Potential Treatment of Peripheral Vessels SANTA CLARA, Calif., March 14, 2023 (GLOBE NEWSWIRE) — Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, today announced the full U.S. commercial availability […]