The Latest Cardiac and Vascular News
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 in the infrapopliteal arteries with […]
WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced the Tack Optimized Balloon Angioplasty II Below the Knee (TOBA II BTK) clinical trial surpassed the 100 patient milestone, advancing enrollment well ahead of schedule. The TOBA II BTK is a prospective, multi-center, single-arm study designed to […]
FRANKLIN LAKES, N.J., Jan. 18, 2018 /PRNewswire/ — Becton, Dickinson and Company (NYSE: BDX), a leading global medical technology company, today announced the completion of enrollment in the Lutonix below-the-knee (BTK) trial and plans to submit a pre-market approval application in late 2018. The Lutonix BTK trial is a prospective, multicenter, randomized, controlled trial intended to demonstrate […]
NETANYA, Israel, October 26, 2017 /PRNewswire/ — Nitiloop, a medical device company dedicated to the development of Cardiovascular and peripheral microcatheters for complex lesions, received FDA clearance for its new Nova Cross™ Extreme and Nova Cross™ BTK. These dedicated microcatheters are joining the Nova Cross™ product family combining innovative low profile microcatheter technology with uniquely designed Nitinol scaffold providing enhanced guidewire and microcatheter support […]
FREMONT, Calif.–(BUSINESS WIRE)–Shockwave Medical, a pioneer in the treatment of calcified cardiovascular disease, today reported positive results from the DISRUPT BTK Study, which were presented at the annual Cardiovascular and Interventional Radiological Society of Europe (CIRSE) congress in Copenhagen, Denmark. DISRUPT BTK, a prospective single arm study, evaluated the use of the Shockwave Medical Lithoplasty […]
(BTK), improving blood flow in severe claudication and critical limb ischaemia. Angiolite BTK design has been specifically elaborated for drug eluting stent and benefits from iVascular proprietary coating nanotechnology that yields a multilayer thin coating with optimal kinetics. “Having the right bail-out options, when performing BTK angioplasty, is extremely important in saving limbs” claims Dr. Peter […]
WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced that its Tack Optimized Balloon Angioplasty II Below the Knee (TOBA II BTK) clinical trial has commenced enrollment in Europe, with the first patient treated by Professor Dr. Marianne Brodmann and Dr. Peter Reif at Medical University Graz, Austria. “The Tack Endovascular System represents […]
WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced the U.S. Food and Drug Administration (FDA) approved an Investigational Device Exemption (IDE) supplemental application to modify the primary endpoint in the Tack Optimized Balloon Angioplasty II Below the Knee (TOBA II BTK) clinical trial from 12 months to 6 months. The TOBA II […]
