FDA Gives Nod to Vascade MVP Closure Device for EP Procedures

Patrice Wendling

December 19, 2018

Cardiva Medical has received premarket approval from the US Food and Drug Administration for its Vascade MVP Venous Vascular Closure System, the company announced.

The device works "by placing a small, collapsible mesh disc against the inside of the vessel wall to temporarily stop the bleeding, releasing a collagen patch into the tissue and then removing the mesh disc," according to the company.

"The collagen patch expands, providing a mechanical and physiological seal to stop the bleeding, and then absorbs into the body, leaving nothing behind and allowing further access to the vessel if additional procedures are required."

The Vascade MVP is the only vascular closure device designed and indicated for multisite venous closure for 6-12 French inner diameter sheaths, the company said in a news release. "This access site approach and size range is the standard in electrophysiology procedures such as cardiac ablation and left atrial appendage closure."

Approval of the Vascade MVP was supported by the AMBULATE Pivotal Trial conducted at 13 US sites and comparing the device with standard compression following cardiac arrhythmia ablation in 204 patients, all with three or four midbore (6-13F inner diameter sheaths) femoral venous access sites.

As announced, the Vascade MVP group showed a median reduction in the primary end point of time to ambulation of 3.9 hours vs manual compression (2.2 hours vs 6.1 hours). Total post-procedure time was reduced by a mean of 3.7 hours (3.1 hours vs 6.8 hours) and time to discharge eligibility by a mean of 3.4 hours (3.1 hours vs 6.5 hours; all P values < .0001).

Patient satisfaction with the duration of bed rest was 63% higher in the Vascade MVP arm. An ad hoc analysis suggested 58% fewer patients treated with the Vascade MVP used opioid-class pain medications.

Follow Patrice Wendling on Twitter: @pwendl

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