PQ Bypass touts subset analysis data from Detour system trial

PQ Bypass today released subset analysis results from the Detour 1 clinical trial of its Detour system designed to treat long-segment blockages in the femoropopliteal artery, touting a 2% rate of major adverse events and no deaths or amputations at 30 days. The data was presented today at the Vascular InterVentional Advances conference, the Sunnyvale, Calif.-based company said. Results came from a 6-month subset analysis of 50 patients who underwent percutaneous treatment of femoropopliteal blockages with lengths between 25 cm and 45 cm, the company said. PQ Bypass said it was sucessfully able to treat the blockages without “significant impact on venous health.” Primary patency at 6 months was reported at 88.9% with optimal placement, and a primary patency of 76.9% was reported overall. Rutherford Class improvements of at least 2 grades were reported in 92% of patients, with significant improvements in ankle brachial index and no impact on venous function reported, the company said. “Patients with long segment femoropopliteal blockages are in need of advanced therapeutic alternatives to existing treatments. While endovascular revascularization is effective in shorter lesions, its durability in longer segment blockages has not matched that of open surgery. Fully percutaneous bypass is designed to combine the durability advantages of surgical bypass with the minimally invasive advantages of a percutaneous procedure. The outcomes we are seeing in the Detour I ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Vascular PQ Bypass Source Type: news