Gore said that the findings were published at Leipzig Interventional Course (LINC) 2019 in Leipzig, Germany. The company is also launching its Fracture-Free Assurance Program for the device in the US, to demonstrate the efficacy of the device in reaching the challenging region behind the knee.
As part of the program, Gore claims that it will refund for device fractures within 10 years of implantation. The program is subject to terms and conditions.
The study was conducted on 100 patients with SFA and PPA occlusive lesions at a single site in Austria. At 12 months, the device is claimed to have met its primary endpoint showing 93% primary patency and 100% secondary patency.
Patients with the device are claimed to have had 95% freedom from target lesion revascularization (TLR) and an improved ankle brachial index (ABI) was observed with an average ABI improvement of 0.21 (from 0.69 at baseline to 0.90 at the 12-months follow-up).
It is also claimed that zero stent frame fractures were observed at 12 months. This and other studies showing a lack of stent frame fractures have led the company to create the new Fracture-Free Assurance Program. All devices have been successfully implanted with no device related complications at the time of implant or within the 30-day implant window.
Gore Vascular Leader Eric Zacharias said: “Peripheral arterial disease in distal anatomy was previously very difficult to treat effectively via stents because the region behind the knee led to high fracture rates. At Gore, we tackled this challenge head on by designing a stent that flexes with the knee while remaining strong to prevent stent frame fractures.
“The extensive data that we have from our previous investigational device exemption (IDE) study and this most recent prospective study show the GORE TIGRIS Vascular Stent is able to deliver precise placement and conformability in complex anatomies leading to long-term efficacy and safety. We have so much confidence in the data behind this device that we have launched our Fracture-Free Assurance Program.”
