Intact Vascular Announces Conditional FDA Approval for Tack Optimized Balloon Angioplasty II (TOBA II) Study and Enrollment of First Patients

The TOBA II Study Is Designed to Demonstrate Enhanced Dissection Repair with the Tack Endovascular System™ Following Balloon Angioplasty

September 30, 2015, 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 has granted conditional approval for a U.S. and European IDE clinical trial to investigate use of the Tack Endovascular System as a dissection repair therapy in patients with peripheral arterial disease (P.A.D.) undergoing percutaneous angioplasty. The Tack Optimized Balloon Angioplasty II (TOBA II) trial has begun with the first patients being treated at Yuma Regional Medical Center (Yuma, Arizona).

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