For below-the-knee arterial dissection repair following balloon angioplasty, innovative medical technology shows sustained treatment effect and positive impact on quality of life for patients with critical limb ischemia (CLI) First and only FDA-approved device of its kind demonstrates consistently high rates of target limb salvage (93.9%) and freedom from clinically-driven […]
Tag: TOBA II
Intact Vascular’s Tack Endovascular System® Receives FDA Approval
WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a private medical device company committed to developing solutions for minimally invasive peripheral vascular procedures, today announced it received U.S. Food and Drug Administration (FDA) approval for the Tack Endovascular System (6F), a purpose-built dissection repair device implanted post-angioplasty in patients with peripheral arterial disease (PAD). […]
Intact Vascular Announces Positive One-Year Data from the TOBA II Clinical Trial
WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced at the 15th annual VIVA conference in Las Vegas that its Tack Optimized Balloon Angioplasty II (TOBA II) clinical trial successfully achieved both primary and secondary endpoints. One year results from the TOBA II study were presented […]
Intact Vascular Announces Presentation of TOBA II Pivotal Data
WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced that data from its Tack Optimized Balloon Angioplasty (TOBA) II pivotal clinical trial will be presented at the 15th Annual VIVA Conference in Las Vegas, NV on November 5-8. The TOBA II trial […]
Intact Vascular Announces Completion of Enrollment in the Tack Optimized Balloon Angioplasty II (TOBA II) Clinical Trial
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 (TOBA II) clinical trial has completed enrollment. A total of 210 patients have been enrolled in TOBA II at 33 sites in the U.S. […]