By creator to www.massdevice.com
Merit Medical (NSDQ:MMSI) introduced that it acquired CE Mark approval in Europe for its Wrapsody endovascular stent graft system.
Wrapsody is a versatile, self-expanding endoprosthesis indicated to be used in hemodialysis sufferers for treating stenosis or occlusion inside central veins, together with the dialysis outflow circuit of an arteriovenous (AV) fistula or AV graft, in accordance with a information launch.
Within the U.S., Wrapsody won an FDA breakthrough nod in November 2019 for hemodialysis remedy, then added indications for stenosis or occlusion within the dialysis outflow circuit just last month. The corporate additionally just lately accomplished enrollment and first follow-up for its Wrapsody First research, which incorporates 46 sufferers in Europe.
Advantage stated within the launch that it plans to supply extra merchandise that make the most of the Wrapsody platform, topic to extra regulatory submissions. It additionally plans to submit a pre-market approval utility to the FDA as soon as it concludes its Wave pivotal research.
“We’re happy to obtain this certificates and the chance to supply this distinctive product to the European group,” Advantage chairman & CEO Fred Lampropoulos said within the launch. “I need to thank the principal investigators of the Wrapsody First research in addition to our analysis and growth, medical affairs and regulatory affairs employees members who labored tirelessly on this venture.”
— to www.massdevice.com
