Philips Reports Positive 3-Yr Research Results From TOBA II Below-the-knee Trial

Royal Philips (PHG), on Monday, announced the latest results from the Tack Optimized Balloon Angioplasty or TOBA II below-the-knee or BTK clinical trial, demonstrating that the Philips endovascular system - Tack (4F) - the first and only device of its kind approved by the U.S. FDA, provides a sustained treatment effect and positive impact on quality of life for patients with critical limb ischemia or CLI, a severe stage of peripheral arterial disease or PAD, out to three years of clinical follow-up.

The TOBA II BTK trial studied the safety and efficacy of post-angioplasty dissection repair using the Philips Tack endovascular system in patients with CLI and infrapopliteal disease.

The company noted that the Tack endovascular system is a unique specialized implantable device to optimize the treatment of dissections in patients with CLI. Endpoints included rates of major adverse events, target lesion revascularization or TLR, target limb salvage or TLS and quality of life (QoL) metrics.

CLI occurs when an obstruction in an artery severely reduces blood flow, causing painful wounds, debilitating rest pain, recurring ulcers and life-threatening infection. If left untreated, 50% of patients with CLI will undergo an amputation or die within the first year.

There were no major adverse events reported through 30 days in either study, the company said.

The TOBA II, TOBA III and TOBA II BTK trials support the safety and efficacy of the Tack endovascular system for post-PTA dissection repair in above- and below-the-knee arterial disease.

Also, the 36-month TOBA II BTK data reported at NCVH adds to the robust body of clinical evidence supporting the safety and effectiveness of the Tack Endovascular System in both vessel beds.

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