Intact Vascular Announces Completion of Enrollment in the Tack Optimized Balloon Angioplasty II (TOBA II) Clinical Trial

The TOBA II clinical trial studies the combination of Intact Vascular’s Tack Endovascular System®with both standard and drug coated balloon angioplasty in the treatment of patients with peripheral artery disease (PAD)

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. and Europe.

The TOBA II trial is a prospective, multi-center, two-arm, non-randomized study designed to investigate the safety and efficacy of the Tack Endovascular System in combination with standard or drug coated balloon (DCB) angioplasty in the arteries above the knee. Target vessels include the superficial femoral artery (SFA) and the proximal segment of the popliteal artery. The Tack Endovascular System is a new technology designed to repair dissections (or tears) in artery walls that frequently occur as a complication of standard or DCB angioplasty. The system allows physicians to repair these dissections while leaving a minimal amount of foreign material in the artery, reducing mechanical stress on the artery, and preserving future treatment options.

The design of TOBA II is unique in that it permits use of the Tack® system following either standard (uncoated) balloon angioplasty or drug coated balloon angioplasty using the BARD Lutonix® DCB. Patients are enrolled in either group based upon the treating physician’s clinical judgement. The primary effectiveness endpoint for TOBA II is Duplex derived patency at 12-months following treatment.

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