Vascular has received approval from the US Food and Drug Administration (FDA) for its tissue tear repair device.
Called Tack Endovascular System, the device is implanted following a balloon angioplasty procedure, which is used to treat peripheral arterial disease (PAD).
When an angioplasty balloon is inflated, it can cause mechanical stress, vessel injury and tears in surrounding tissues. If left untreated, these tears can cause acute thrombosis and arterial occlusions.
The Tack Endovascular System is pre-loaded with six self-expanding nitinol implants designed for above-the-knee (ATK) surgery. It reduces vessel inflammation, minimises the risk of metal remaining in the body after a procedure, and improves clinical outcomes.
Intact Vascular president and CEO Bruce Shook said: “The Tack system’s unique combination of minimal metal and highly targeted dissection repair is an ideal fit with today’s focus on minimising inflammation and improving long-term outcomes.”
The FDA’s approval is based on results from the TOBA II clinical trial, which met all primary endpoints. Intact noted that 92% of tears were resolved after treatment, and the trial showed the safety and effectiveness of the device.
The Tack Endovascular System is said to have demonstrated 79.3% Kaplan-Meier (K-M) vessel patency along with 86.5% K-M freedom from clinically driven reintervention at 12 months. The implant was associated with zero fractures.
The findings from the TOBA II clinical trial were presented at the 2018 VIVA conference.
TOBA II trial principal investigator William Gray said: “Post-angioplasty dissections can significantly impact patient outcomes. Having a minimal metal solution that specifically addresses dissections and improves angioplasty results while preserving future treatment options is extremely exciting.”
The Tack device has been recently launched in Europe, and Intact is planning for an initial limited release in the US.