Tag: BTK

Reflow Medical Receives CE Mark for Bare Temporary Spur Stent System for Treating de novo or Restenotic Below-the-Knee (BTK) Lesions

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 […]

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 […]

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 […]

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 […]