Peripheral/Endo

Early Evaluation of Transcarotid Artery Revascularization (TCAR) Versus Carotid Endarterectomy (CEA) Cost-Effectiveness

Rosemont, Ill., Dec. 27, 2021 (GLOBE NEWSWIRE) — A cost-effectiveness model based on peer-reviewed sources suggests that although five-year costs for transcarotid artery revascularization (TCAR) were higher than those for carotid endarterectomy (CEA), TCAR afforded greater quality-adjusted life years (QALY). The study is published in the December 2021 issue of […]

Philips receives FDA De Novo Clearance for IVC Filter Removal Laser Sheath – CavaClear – with Breakthrough Device Designation

December 22, 2021 Philips IVC Filter Removal Laser Sheath – CavaClear – is intended to safely ablate tissue to remove embedded IVC filters CavaClear is a first-in-class FDA-cleared solution for advanced IVC filter removal It is estimated that in the United States more than one million patients with IVC filters […]

FDA Grants Marketing Authorization for Inferior Vena Cava Filter Removal Device

SILVER SPRING, Md., Dec. 21, 2021 /PRNewswire/ — Today, the U.S. Food and Drug Administration authorized marketing of the first laser-based device for the removal of Inferior Vena Cava (IVC) filters. The device is designed for patients who have an IVC filter, a small cage-like device inserted into the largest vein in […]

FDA Approves Two New Indications for XARELTO® (rivaroxaban) to Help Prevent and Treat Blood Clots in Pediatric Patients

XARELTO® is available as both an oral tablet and oral suspension formulation for use in appropriate children less than 18 years of age Convenient oral suspension formulation advances standard of care for children; alleviates administration challenges found with injectable alternatives XARELTO® now has 11 indications, the most of any direct […]

Vesper Medical Announces Completion of Enrollment in the VIVID Clinical Trial

Company Achieves Key Milestone in the Development of Its Next Generation Deep Venous Stent System WAYNE, Pa.–(BUSINESS WIRE)–Vesper Medical, Inc., a developer of medical devices for deep venous disease, today announced the completion of enrollment in its pivotal study – Venous stent for the Iliofemoral Vein Investigational clinical trial using the Vesper DUO Venous Stent […]

Fist Assist Devices Receives FDA “Breakthrough Device” Designation for the World’s First Wearable Vein Dilation Device for ESRD Patients

Indication for Pre-Surgical Vein Dilation Use to Promote AV Fistula Creation LAS VEGAS–(BUSINESS WIRE)–Fist Assist Devices, LLC, an innovative medical device company focused on vein dilation to facilitate the Chronic Kidney Disease (CKD) patient’s journey through End-Stage Renal Disease (ESRD), announced today that it received “Breakthrough Device” designation from the […]

Sky wins FDA clearance to market the geko™ device for venous insufficiency and ischemia – a therapy area sorely in need of innovation.

The geko™ device increases blood flow in lower limb soft tissue of patients with venous insufficiency and/or ischemia. DARESBURY, England, Dec. 16, 2021 /PRNewswire/ — Medical devices company, Sky Medical Technology Ltd, has today announced U.S. Food and Drug Administration (FDA) 510(k) clearance to market the geko™ device for increasing microcirculatory blood flow in […]

Philips to further expand its image-guided therapy devices portfolio through acquisition of Vesper Medical

Amsterdam, the Netherlands – Royal Philips (NYSE: PHG; AEX: PHIA), a global leader in health technology, today announced that it has signed an agreement to acquire Vesper Medical Inc., a US-based medical technology company that develops minimally-invasive peripheral vascular devices. Vesper Medical will further expand Philips’ portfolio of diagnostic and therapeutic devices […]

InterVene’s BlueLeaf Endovenous Valve Formation (EVF) System Granted Breakthrough Device Designation by the FDA

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–InterVene Inc. announced today that it has received Breakthrough Device Designation by the FDA for the company’s BlueLeaf® Endovenous Valve Formation System. BlueLeaf is the first catheter-based solution developed for deep vein reflux — the failure of venous valves in the legs — which does not require […]

Bluegrass Vascular Announces New Paper Reporting Ability to Eliminate Use of a Femoral Catheter with the Surfacer® System

December 8, 2021, San Antonio, TX – Bluegrass Vascular Technologies, a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, announced today the publication of a case report demonstrating the ability to utilize the Surfacer® System to perform the Inside-Out® procedure and obtain right-sided central venous access […]