Enrollment Begins in BELONG Study of VentureMed's Flex Vessel Preparation System
January 22, 2019—VentureMed Group, Inc. announced the enrollment of the first patients in the BELONG study, which is evaluating the benefit of the company's Flex system for arterial vessel preparation before drug-coated balloon (DCB) angioplasty of the superficial femoral artery (SFA) and popliteal artery (PA).
The Flex system is designed to create long, parallel, linear microincisions in all plaque morphologies to prepare an ideal vessel environment to facilitate DCB angioplasty for the treatment of difficult diseased vessels, improving vessel compliance and acute lumen gain.
According to the company, the study's primary objective is to evaluate lumen patency at 12 months obtained by preparation of vessels with the Flex vessel preparation system before conventional endovascular recanalization of the SFA and PA. This prospective, single-arm, nonrandomized study will enroll up to 150 patients in Switzerland. Patients will exit from the study at the completion of their 12-month follow-up.
The study is led by Primary Investigator Daniel Périard, MD, with Coinvestigator PD Rolf P. Engelberger, MD.
In the company's press release, Dr. Périard commented, "We believe preparing arterial vessels by delivering parallel longitudinal microincisions with the Flex system prior to DCB angioplasty has the potential to demonstrate long-term clinical benefits for patients. Our early results have shown that arterial vessel preparation with the Flex system resulted in improved lumen expansion and vessel compliance after DCB angioplasty, with a corresponding reduction in the rate of dissection. We look forward to completing the BELONG study and providing additional clinical evidence to demonstrate and better understand the benefits of vessel preparation with the Flex system."