Philips Tack Endovascular System Safety and Efficacy Evaluated in TOBA II BTK at 3-Year Analysis

June 13, 2022—Royal Philips announced the latest results from the TOBA II below-the-knee (BTK) clinical trial of the company’s Tack (4F) endovascular system. The device demonstrated a sustained treatment effect and positive impact on quality of life (QoL) for patients with critical limb ischemia (CLI) out to 3 years of clinical follow-up.

According to the company, the TOBA II BTK trial studied the safety and efficacy of postangioplasty dissection repair using the Tack endovascular system in patients with CLI and infrapopliteal disease. Endpoints included rates of major adverse events, target lesion revascularization (TLR), target limb salvage (TLS), and QoL metrics.

George Adams, MD, Coprincipal Investigator of TOBA II BTK, presented the results at the 2022 New Cardiovascular Horizons (NCVH) annual conference held May 31 to June 2 in New Orleans, Louisiana.

“Based on 36-month follow-up in the TOBA II BTK trial, which is following 233 patients at 41 sites internationally, the Tack endovascular system offers a new standard in repairing BTK arterial dissections,” commented Dr. Adams in the company’s press release.

Dr. Adams continued, “The device stands to significantly benefit patients with CLI whose treatment with balloon angioplasty often leads to this particular complication, which typically goes untreated and unaddressed, to the detriment of long-term clinical outcomes.” Dr. Adams is Director of Cardiovascular and Peripheral Vascular Research at UNC Rex Hospital in Raleigh, North Carolina, and Clinical Associate Professor of Medicine at the University of North Carolina at Chapel Hill, North Carolina.

As summarized in the Philips press release, the 3-year analysis of TOBA II BTK results included:

• 93.9% TLS in CLI patients at 3 years
• 69.6% freedom from clinically driven TLR across all patients at 3 years
• Sustained improvement in established clinical classification systems, including the Rutherford clinical category and hemodynamics in ankle- and toe-brachial indices
• Sustained improvement in patient-reported QoL and mobility measures

The Philips Tack endovascular system has been approved by the FDA and is currently available for sale in the United States and some countries in the European Union.

Philips noted that it has previously reported data from the TOBA II and III studies, which evaluated the Tack endovascular system for superficial femoral and proximal popliteal artery dissection repair following uncoated balloon angioplasty and/or drug-coated balloon (DCB) angioplasty. These global and European multicenter studies demonstrated that the use of the Tack endovascular system resulted in overwhelming dissection resolution after uncoated or DCB angioplasty. There were no major adverse events reported through 30 days in either study.

The company stated that the TOBA II, TOBA III, and TOBA II BTK trials together support the safety and efficacy of the Tack endovascular system for post–percutaneous transluminal angioplasty dissection repair in above- and below-the-knee arterial disease. The 36-month TOBA II BTK data reported at NCVH add to the robust body of clinical evidence supporting the safety and effectiveness of the Tack endovascular system in both vessel beds.