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).

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

“Having a minimal metal solution that specifically addresses dissections and improves angioplasty results while preserving future treatment options is extremely exciting.”

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.