VentureMed Group Receives European Medical Device Regulation (MDR) Certification for FLEX Vessel Prep™ System
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"MDR certification demonstrates our commitment to quality and will enable continued commercial expansion of the FLEX Vessel Prep System into the CE marked geographies." said Denis Harrington, VentureMed's President and CEO.
About VentureMed Group, Inc. and the FLEX Vessel Prep System
VentureMed Group, Inc. develops and markets innovative endovascular medical devices to solve unmet medical needs in the treatment of stenoses of AV fistulas and grafts and PAD. The FLEX VP™ System is a unique, non-balloon-based approach to optimizing revascularization. FLEX creates controlled-depth micro-incisions, 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 pre-treatment to optimize outcomes in complex stenoses & lesions of any length or vessel morphology. The FLEX VP System received CE Mark and 510(k) clearance from the US Food and Drug Administration.
For more information, visit www.VentureMedgroup.com.
Media contact: Kathy Leith
Kleith@venturemedgroup.com
(763-296-2026)
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