VentureMed Group has received European Medical Device Regulation (MDR) certification for its FLEX Vessel Prep System.
The FLEX VP System, a non-balloon-based method for optimising revascularisation, has already received CE Mark and 510(k) clearance from the US Food and Drug Administration.
VentureMed president and CEO Denis Harrington said: “MDR certification demonstrates our commitment to quality and will enable continued commercial expansion of the FLEX Vessel Prep System into the CE-marked geographies.”
The device has been designed to deliver controlled and predictable pre-treatment for optimising outcomes in complex stenoses and lesions of any length or vessel morphology.
It creates micro-incisions at controlled depths, relieving circumferential tension. This is expected to enhance vessel compliance while enabling luminal gain at lower pressure and with less vessel trauma, thereby reducing the risk of restenosis.
VentureMed clinical, regulatory and quality vice-president Jill Schweiger said: The 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.
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“This significant achievement is a testament to our company’s dedication to providing the safest and highest quality products for our customers and their patients.”
VentureMed is focused on the development and marketing of advanced endovascular medical devices for the treatment of arteriovenous fistulas and grafts, as well as peripheral arterial disease.