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 […]
Tag: BTK
TOBA II BTK Trial Enrollment Ahead of Schedule for the Tack Endovascular System® in Below the Knee Disease
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 […]
BD Announces Completion of Enrollment in the Lutonix 014 Drug Coated Balloon Below-the-Knee Trial
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 […]
Nitiloop Announces FDA 510(k) Clearance for its Nova Cross Extreme and Nova Cross BTK Micro catheter for Support of Guidewire Access to Discrete Regions of the Coronary and Peripheral Vasculature
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 […]
Shockwave Medical Shows Off Disrupt BTK Lithoplasty System Study Results
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. […]
Angiolite BTK, below the knee sirolimus-eluting stent, changed CE Mark Approval
(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 […]
Intact Vascular Announces Enrollment Of First European Patient In Tack Optimized Balloon Angioplasty II Below The Knee (TOBA II BTK) Clinical Trial With The Tack Endovascular System
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 […]
Intact Vascular Release: FDA Approves 6-Month Primary Endpoint For The Tack Endovascular System In Below The Knee Disease
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 […]