– VentureMed Group Receives European Medical Device Regulation (MDR) Certification for FLEX Vessel Prep™ System
MINNEAPOLIS, Sept. 6, 2023 /PRNewswire/ — VentureMed Group, Inc., a privately held medical device innovator in access management for arteriovenous (AV) fistulas and grafts and vessel preparation for the interventional treatment of disease Peripheral Arterial System (PAD) today announced that the company is one of the first to receive MDR certification. Obtaining MDR certification ensures that the FLEX device is aligned with the outlined requirements and conformity assessment procedures that must be followed before medical devices are introduced into the European Economic Area.
“The CE marking under these new requirements is more stringent than the CE marking under the Medical Device Directive and focuses on both quality and patient safety. This significant achievement is a testament to our company’s dedication to providing the safer, higher-quality products for our customers and their patients,” said Jill Schweiger, VentureMed’s vice president of clinical and regulatory quality.
“MDR certification demonstrates our commitment to quality and will enable the continued commercial expansion of the FLEX Vessel Prep System into CE Mark geographies,” said Denis Harrington, President and CEO of VentureMed.
About VentureMed Group, Inc. and the FLEX Vessel Prep System
VentureMed Group, Inc. develops and markets innovative endovascular medical devices to address unmet medical needs in the treatment of AV fistula and graft stenosis and PAD. The FLEX VP™ System is a unique, balloon-free approach to optimizing revascularization. FLEX creates microincisions of controlled depth, releasing circumferential tension that can lead to better vessel compliance, allowing luminal gain at lower pressure and with less vascular trauma, which can help limit restenosis. FLEX was designed to provide controlled and predictable pretreatment to optimize outcomes in strictures and complex lesions of any vessel length or morphology. The FLEX VP System has received CE Mark and 510(k) clearance from the US Food and Drug Administration.
For more information, visit www.VentureMedgroup.com.
Medios Contact: Kathy LeithKleith@venturemedgroup.com(763-296-2026)
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