Philips’ Tack Endovascular System Shows Sustained Efficacy in 2-Year TOBA II BTK Data

June 3, 2021—Royal Philips announced results from the Tack Optimized Balloon Angioplasty (TOBA) II below-the-knee (BTK) clinical trial of the company’s Tack endovascular system (4F), a dissection repair device. In the trial, the Tack system demonstrated a sustained treatment effect and positive impact on quality of life at 2 years in the treatment of peripheral artery disease (PAD) and critical limb ischemia (CLI) patients.

The 2-year data were presented by the TOBA II BTK trial’s coprincipal investigator George Adams, MD, at NCVH 2021, the New Cardiovascular Horizons conference held June 1-4 in New Orleans, Louisiana.

According to Philips, the TOBA II BTK investigational device exemption study enrolled 100% dissected vessels. Data across all patients in the TOBA II BTK clinical trial at 2 years included 73.6% freedom from clinically driven target lesion revascularization. In the more complex CLI patient population, the data showed 94.7% target limb salvage.

Additionally, the 2-year TOBA II BTK data showed a sustained improvement in patients’ quality of life in a patient questionnaire that assessed activity, pain, and overall health. Patients reported having more control of their health and increased improvement in mobility, noted the company.

“The global endovascular community is diligently working to better understand how to restore blood flow in small limb vessels, promote healing, and ultimately preserve limbs for people with CLI, one of the most vulnerable and critical patient populations,” commented Dr. Adams in the company’s press release. “These positive 2-year data reiterate the clinical importance of BTK dissection repair and validates the sustained durability of Tack-optimized interventions.”

Philips advised that the Tack endovascular system is currently available for sale in the United States and select countries in the European Union.

In April 2020, the Tack endovascular system (4F) was launched in the United States after receiving FDA approval for the repair of postangioplasty dissections in the mid/distal popliteal, tibial, and/or peroneal BTK arteries ranging in diameter from 1.5 to 4.5 mm.

In August 2020, Philips acquired Intact Vascular, which developed the Tack device.