Dive Brief:

• Intact Vascular received FDA premarket approval for a first-of-its-kind, minimally invasive device to repair above-the-knee dissections, or tears in the artery wall, after balloon angioplasty to treat peripheral arterial disease, or PAD, the company said Monday.
• Approval for the implant, called the Tack Endovascular System, was based on the company's TOBA II pivotal trial that met its primary goals for safety and efficacy, with 92.1% of dissections resolved after treatment.
• The Wayne, Pennyslvania-based medtech, which in January announced the launch of the Tack system in Europe, said it plans a limited initial release of the device in the United States that will progress to broader market distribution.

Dive Insight:

Vessel dissection is a frequent outcome following angioplasty to treat PAD, with severe forms occurring in 42% of cases in one study. Vessels can be vulnerable to injury from stress caused by inflation of the angioplasty balloon. 

A dissection can cause blood clots or blockages known as arterial occlusions. Stents are typically used to address dissections but face their own challenges, including fractures and restenosis, or artery re-clogging, which can necessitate a repeat procedure.

Intact Vascular said its Tack implant is intended to preserve vessel integrity and improve blood flow after balloon angioplasty to unclog an artery. The device has minimal metal to reduce inflammation, uses low radial force, and is specifically designed for dissection repair, the company said.

It is indicated for use in the superficial femoral and proximal popliteal arteries that carry oxygenated blood to the leg. The device can treat multiple dissections with a single catheter and leaves behind 70% less metal than a stent, according to Intact Vascular.

The TOBA II trial was one of the first peripheral vascular studies to enroll patients with 100% dissected vessels. It studied the combination of the Tack implant with plain angioplasty balloons and the BD Interventional Lutonix drug-coated balloon in arteries above the knee. The study of 213 patients with PAD who underwent balloon angioplasty showed 92.1% dissection resolution and 86.5% freedom from reintervention at 12 months, and zero implant fractures. The safety endpoint was met with zero major adverse events at 30 days.

The company is conducting two additional clinical trials for the Tack device. TOBA II BTK has completed enrollment and is investigating the Tack implant with plain balloon angioplasty in arteries below the knee. TOBA III, which has completed enrollment in Europe, is investigating use of the Tack implant with the Medtronic IN.PACT Admiral drug-coated balloon, with a long lesion subset.

Paclitaxel-coated balloons and stents are under FDA scrutiny after an analysis published in the Journal of the American Heart Association in December linked the devices to a higher risk of death in patients two years after treatment. Last month, FDA warned healthcare providers to avoid the devices after its own preliminary analysis of long-term data showed a 50% higher risk of mortality in people who received the devices versus a control group.

BD has said it stands behind the clinical data for its Lutonix drug-coated balloon, while Medtronic has released five-year data from its IN.PACT Admiral study that showed no statistical difference in all-cause mortality between patients who received that device and those who underwent plain balloon angioplasty.

FDA will hold an advisory committee meeting in June to discuss the mortality signal and re-examine the benefit-risk profile of the devices.