Haemonetics Earns Expanded FDA Nod for Vascular Closure in PFA, LAAC

Haemonetics has gained U.S. Food and Drug Administration (FDA) approval to expand the label of its Vascade MVP XL venous vascular closure system to procedures using 10-14 Fr inner diameter (ID) and up to 17 Fr outer diameter (OD) procedural sheaths.

Thanks to this label expansion, the system is now approved for larger sheaths used in technologies for pulsed field ablation (PFA) and left atrial appendage closure (LAAC) to treat atrial fibrillation (AFib).

Approval was supported by data from the AMBULATE EXPAND trial, which evaluated technologies using 17 Fr maximum OD procedural sheaths, such as PFA and LAAC. The study enrolled 77 subjects and showed no major or minor access site closure-related complications, as well as a median time to ambulation (TTA) of 2.4 hours.

The Vascade MVP XL system touts a 25 Fr diameter disc and 19 milligrams of resorbable, thrombogenic collagen. It’s been available in the U.S. for use with 10-12 Fr ID and 15 Fr maximum OD procedural sheaths, and is not the only extravascular venous closure system proven in electrophysiology procedures using up to 17 Fr OD procedural sheaths, the company said.

“VASCADE MVP XL has become the device of choice in advanced vascular closure, delivering differentiated clinical benefits and economic advantages for healthcare providers,” said Ken Crowley, VP and GM, Interventional Technologies at Haemonetics. “With label expansion approval for fast-growing PFA and LAAC technologies, we are poised to accelerate our commercial strategy and momentum, with opportunities to support a greater number and broader range of procedures at hospitals and ambulatory surgical centers across the U.S.”

Last month, the company earned FDA clearance for its NexSys PCS plasma collection system with Persona PLUS technology.