August 10, 2020
Veryan Medical to Commercialize Vasorum’s Celt Arterial Closure Device in the United States
August 10, 2020—Vasorum Ltd. and Veryan Medical Ltd. announced that Veryan Medical will support the commercialization of Vasorum's Celt arterial closure device (ACD) in the United States.
Vasorum has received FDA premarket approval and European CE Mark approval for the Celt ACD, which is designed to allow rapid closure of an arterial puncture site after percutaneous catheter-based vascular procedures. The company stated that Celt ACD is available in three sizes to fit 5-, 6-, and 7-F sheaths and does not require an exchange of the existing procedural sheath before deployment.
“I have been using the Celt ACD for several years and have completed over 1,000 implants,” commented Syed Hussain, MD, in the announcement. Dr. Hussain is Chairman of Vascular & Endovascular Surgery at the Christie Clinic in Champaign, Illinois. “The device is extremely easy to use and has unique benefits including rapid hemostasis allowing for safe patient ambulation shortly after the procedure.”
Vasorum is based in Dublin, Ireland. Veryan Medical, an Otsuka Medical Devices company, has headquarters in Horsham, United Kingdom. Veryan Medical is the manufacturer of the BioMimics three-dimensional (3D) nitinol stent, which is currently being evaluated in the European MIMICS-3D registry.
Nick Yeo, Veryan Medical’s CEO, stated in the press release, “We are pleased to be working with Vasorum and the Celt ACD, which has proven to be a game-changing closure technology. We plan to include the Celt device as an option in our MIMICS-3D USA registry, which will start enrolling later this year.
“MIMICS-3D USA is a prospective, multicenter observational study evaluating the safety, effectiveness, and device performance of the BioMimics 3D vascular stent system within a real-world clinical population of patients undergoing femoropopliteal intervention. MIMICS-3 USA will enroll more than 500 patients in 40 clinical sites across the United States and Veryan will conduct a subanalysis of patients who have had a Celt ACD used in the index procedure.”