The company made Vascade MVP XL fully available to U.S. hospitals as an option to promote rapid hemostasis.
Haemonetics began the initial rollout for the system, which holds FDA premarket approval, in June. That limited launch reached about 80 physicians at more than 30 hospitals for a range of different procedures. The device expands the Vascade portfolio of vascular closure systems with collapsible disc technology and resorbable collagen patches.
Vascade MVP XL features 58% more collagen and a larger disc than the Vascade MVP system. It offers a robust closure solution for procedures requiring 10-12F sheaths (up to 15F in outer diameter). Those could include cryoablation, pulsed field ablation and left atrial appendage closure (LAAC).
The current Vascade portfolio also includes the small-bore Vascade system with standard 5-6/7F procedural sheaths and the Vascade MVP system for mid-bore closure with 6-12F ID procedural sheaths.
“We received overwhelmingly positive feedback during our limited market release and we are excited to make VASCADE MVP XL available to physicians at all U.S. hospitals as soon as possible,” said Stew Strong, president, global hospital at Haemonetics. “With our full market release underway and an ongoing clinical trial program to broaden the indications for this device to even larger access points, VASCADE MVP XL will complement our Interventional Technologies portfolio, and underscore our aspiration to be the go-to leader in vascular closure.”