Peripheral/Endo

Bolt Medical Announces Completion of Enrollment of RESTORE ATK Pivotal Trial for the Unique Bolt Intravascular Lithotripsy System

Bolt Medical completes the enrollment of RESTORE ATK pivotal trial for the treatment of peripheral arterial disease with its unique intravascular lithotripsy system. CARLSBAD, Calif., April 22, 2024 /PRNewswire-PRWeb/ — Bolt Medical, Inc., a clinical stage medical device company is…

Innovative Aspiration Thrombectomy System by Expanse ICE Receives FDA Clearance for vessels of the peripheral arterial and venous systems

PLEASANTON, Calif., April 22, 2024 /PRNewswire/ — Expanse ICE announced today the ICE Aspiration System has received 510(k) clearance from the U.S. Food and Drug Administration. This announcement introduces a new and exciting player in the peripheral thrombectomy market. The ICE…

Vivasure Medical Announces First Large Hole Venous Patient Treated with PerQseal Elite Vascular Closure System

GALWAY, Ireland–(BUSINESS WIRE)–Vivasure Medical®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced it has treated the first large bore venous patient with the PerQseal® Elite vascular closure system, a sutureless and fully bioresorbable large-bore vessel closure […]

AdrenoMed Receives FDA Fast Track Designation for Enibarcimab for Treatment of Septic Shock

HENNIGSDORF, Germany and BERLIN, April 10, 2024 (GLOBE NEWSWIRE) — AdrenoMed AG, the vascular integrity company, today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to its lead product candidate enibarcimab, a first-in-class non-neutralizing monoclonal antibody, for the treatment of septic shock. AdrenoMed is now preparing a confirmatory Phase IIb/III clinical trial to confirm the reduced septic shock mortality under enibarcimab treatment employing a precision medicine approach.

InspireMD to Present at the 23rd Annual Needham Virtual Healthcare Conference

TEL AVIV, Israel and MIAMI, April 03, 2024 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that Marvin Slosman, Chief Executive Officer, will deliver a company update presentation at the 23rd Annual Needham Virtual Healthcare Conference, which is being held April 8-11, 2024.

Elixir Medical Receives FDA Breakthrough Device Designation for the DynamX BTK System for Use in the Treatment of Chronic Limb-Threatening Ischemia Resulting From Below-The-Knee Arterial Disease

MILPITAS, Calif.–(BUSINESS WIRE)–Elixir Medical, a developer of disruptive technologies to treat cardiovascular and peripheral disease, today announced it has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its DynamX® BTK System, a novel, adaptive implant for use in the treatment of narrowed or blocked vessels below-the-knee (BTK) in patients with chronic limb-threatening ischemia (CLTI). The DynamX Bioadaptor platform is a medical technology d