Interventional vascular solutions provider VentureMed Group has started enrollment in Switzerland in the study named BEnefit of arterial vessel preparation by LONGitudinal micro-incisions (BELONG) before drug eluting balloon angioplasty of the superficial femoral and popliteal arteries.
Image: The FLEX System will create long parallel linear micro-incisions. Photo: courtesy of jk1991 at FreeDigitalPhotos.net.
VentureMed said the clinical study intends to evaluate lumen patency at twelve months obtained by preparation of vessels with the FLEX Vessel Preparation System prior to conventional endovascular recanalization of the SFA and PA.
The FLEX System is expected to create long parallel linear micro-incisions in all plaque morphologies to prepare an ideal vessel environment to allow drug-coated balloon angioplasty.
Up to 150 patients have been enrolled for this prospective, single arm, non-randomized study in Switzerland. Patients are allowed to exit from the study at the completion of their twelve-month follow-up.
For the study, Dr. Daniel Périard, Angiology and PD is serving as the primary investigator and and Dr. Rolf P Engelberger, Angiology, is serving as co-investigator. Both are from HFR- Hôpital Cantonal Fribourg.
Dr. Periard said: “We believe preparing arterial vessels by delivering parallel longitudinal micro-incisions with the FLEX System prior to drug-coated balloon 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 drug-coated balloon 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.”
In a presentation entitled Arterial Preparation Improves Outcomes of Drug Coated Balloon Angioplasty, at the VEITH 45th Annual Symposium, Daniel Hayoz, Head of the Medical Clinic at HFR- Hôpital Cantonal Fribourg has introduced the BELONG Study.
VentureMed Group, Jobst Vascular Institute, Promedica Healthcare Systems founder and chief science officer, Dr. John Pigott, MD said: “VentureMed Group is honored that such an accomplished group of interventionalists at an outstanding medical center in Switzerland will be evaluating the FLEX System in a rigorous clinical trial to evaluate long term outcomes.”
VentureMed Group said it will be exhibiting at the Leipzig Interventional Course (LINC) and the International Symposium on Endovascular Therapy (ISET) in January 2019 and Dr. Periard is expected to be presenting The BELONG Study recruitment status and early results at the LINC.