VentureMed’s Flex Vessel Prep System Receives European MDR Certification

September 6, 2023—VentureMed Group, Inc. announced that the company has received European Medical Device Regulation (MDR) certification for the company’s Flex vessel prep (VP) system. VentureMed is a privately held medical endovascular device company focused on access management for arteriovenous (AV) fistulas and grafts and vessel preparation for interventional treatment of peripheral artery disease.

According to the company, the MDR certification for Flex is in alignment with described requirements and conformity assessment procedures that must be met before medical devices are introduced into the European Economic Area. The Flex VP system has CE Mark approval and FDA 510(k) clearance.

“CE Mark under these new requirements is more stringent than the CE Mark under the Medical Device Directive and is focused on quality as well as patient safety,” commented Jill Schweiger, VentureMed’s Vice President of Clinical, Regulatory, and Quality, in the company’s press release. “This significant achievement is a testament to our company’s dedication to provide the safest and highest quality products for our customers and their patients.”

Denis Harrington, VentureMed’s President and CEO, added, “MDR certification demonstrates our commitment to quality and will enable continued commercial expansion of the FLEX VP system into the CE-marked geographies.”

VentureMed stated the Flex VP system is a non–balloon-based approach to optimizing revascularization. The Flex device creates controlled-depth microincisions, releasing circumferential tension that may lead to improved vessel compliance, enabling luminal gain at lower pressure and with less vessel trauma, which may help limit restenosis.

Flex was designed to provide controlled and predictable pretreatment to optimize outcomes in complex stenoses and lesions of any length or vessel morphology, noted the company.