Intact Vascular said a 1st-in-human study of a device designed to repair arterial dissections after angioplasty has produced encouraging results.
Details of the safety and feasibility study involving 11 patients were published in the Journal of the American College of Cardiology: Cardiovascular Interventions, along with supporting preclinical data.
Testing revolved around the Pennsylvania company’s Tack endovascular system, which is designed to use a minimal metal implant to repair post-angioplasty arterial dissections, an innovation over current treatment standards thought to reduce vessel trauma and inflammation. The 11 patients had 25 treated lesions between them, and the study took place at 2 Paraguay hospitals.
Researchers looked at the patients post-procedure and after 12 months. They found surgeons achieved a 100% repair level of dissection flaps. At 1 year, there was an 87.5% patency rate for superficial femoral artery and popliteal vessels, and an 83.3% patency rate for superficial femoral artery, popliteal and tibial artery vessels treated.
For patients who just had tibial vessels treated, there was an 80% patency rate, according to the study.
No patient lost a limb or had their implant migrate. Researchers noted 1 target legion revascularization and death occurred, but it was not related to the device or procedure.
Intact Vascular president & CEO Bruce Shook said the data, combined with recently presented 12-month European TOBA clinical trial data, give the company a good impetus to proceed.
Both, Shook said in prepared remarks, "make for a strong foundation as we move forward."
Shook took over the corner office at Intact Vascular last July. He is the co-founder and former CEO of Neuronetics and the ex-president of Abiomed (NSDQ:ABMD).
