Vascular-focused device developer VentureMed said yesterday that it has launched another study of its Flex dynamic scoring catheter, this one to measure how open patients’ blood vessels remain 12 months after treatment.
The prospective, single arm, non-randomized study in Switzerland will enroll up to 150 patients whose superficial femoral and popliteal arteries were scored by the Flex system before drug-eluting balloon angioplasty. Flex creates long, parallel, linear micro-incisions in all plaque-lined arteries.
Dr. Daniel Périard and Dr. Rolf Engelberger, both of the angiology department at HFR- Hôpital Cantonal Fribourg, are the primary investigator and co-investigator of the BELONG study, which stands for BEnefit of arterial vessel preparation by LONGitudinal micro-incisions.
“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,” Periard said in a prepared statement. “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.”
“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,” said John Pigott, M.D., founder and chief science officer of VentureMed.
A poster of the BELONG study won Best Poster at the 2018 Union of Vascular Societies of Switzerland at the organization’s meeting in Lugano. Periard is scheduled to speak about the study’s recruitment status and early results at the Leipzig Interventional Course on January 22, 2019, in Leipzig, Germany, where VentureMed will have an exhibit. The company will also be present at the International Symposium on Endovascular Therapy (ISET) Jan. 27-30, 2019 in Hollywood, Fla.
In November 2018, Toledo, Ohio-based VentureMed launched its iDissection Classification study using intravascular ultrasound to identify the health of vessels after treatment with the Flex system.