New results suggest that the Tigris vascular stent (Gore) is a safe and effective device that can be incorporated into a modern “leave-nothing-behind” treatment algorithm that reserves stent usage for more challenging patients. These findings were recently presented at the Leipzig Interventional Course (LINC; 22–25 January 2019, Leipzig, Germany).
Gore has also announced the launch of its Fracture-Free Assurance Program for the device in the United States. Under the programme, the company will provide a refund for device fractures within 10 years of implantation.
The prospective, physician-sponsored registry study evaluated the safety and efficacy of the Gore Tigris vascular stent in treating SFA and PPA occlusive lesions of 100 patients at a single site in Austria. At 12 months, the device met its primary endpoint demonstrating 93% primary patency and 100% secondary patency. Patients with the device had 95% freedom from target lesion revascularisation (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).
Additionally, zero stent frame fractures were observed at 12 months. This and other studies showing a lack of stent frame fractures led Gore to create the new Fracture-Free Assurance Program confirming its confidence in the stent. All devices were successfully implanted with no device related complications at the time of implant or within the 30-day implant window.
“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,” commented Eric Zacharias, Vascular Leader at Gore.