VentureMed receives CE mark approval for FLEX catheter


VentureMed has received CE mark approval for its FLEX Plaque Modification Catheter.

The catheter is an over-the-wire, percutaneous device that delivers three dynamic linear scores in a single pass. VentureMed says that the proprietary trielement design allows the operator to safely and effectively prepare any length diseased vessel with a single catheter, in a single pass, in preparation for adjunctive therapy.

A company press release states that by incorporating Dynamic Scoring, FLEX offers an effective and safe alternative to balloon-based scoring technology. Without the need for multiple balloon inflations, the operator can effectively treat a much wider range of vessel lengths and diameters—not only saving time but also cost. FLEX is indicated for use in the superficial femoral and popliteal arteries.

“The FLEX platform offers an easy to use and cost-effective alternative for vessel preparation—especially prior to a drug-coated balloon or drug-eluting stent,” reports John Pigott, VentureMed’s founder and chief science officer. “Through extensive testing, we have demonstrated FLEX to be a safe and effective device.”