Venous Indication Approved for Cardinal Health's MynxGrip Vascular Closure Device

November 4, 2014—Cardinal Health announced that its MynxGrip vascular closure device received US Food and Drug Administration approval for use to close femoral veins. The MynxGrip device is now indicated for use to seal 5-F, 6-F, and 7-F femoral arterial and femoral venous access sites. The MynxGrip device is intended to reduce times to hemostasis and ambulation, thereby potentially shortening postprocedure recovery times, stated the company.

According to the company, the venous indication could help interventional health care providers increase efficiency of their labs and minimize potential complications associated with venous closure by replacing the need for manual compression. The new venous indication does not include any changes to the existing MynxGrip vascular closing device. Cardinal Health is mailing new Instructions for Use documents and Patient Brochures to all current MynxGrip users and those users can immediately begin using the existing device to close femoral veins, advised the company.

According to Cardinal Health, the MynxGrip vascular closure device utilizes the company’s extravascular Grip sealant that actively adheres to the vein for a secure mechanical closure and dissolves within 30 days, leaving nothing permanently behind in the healed vein. The safety profile of this secure extravascular sealant makes the MynxGrip device uniquely suited for venous closure, as it does not leave behind an intravascular component.

Sanjay Srivatsa, MD, commented in the company’s press release, “The gentle deployment and secure extravascular sealant make the MynxGrip device an excellent option for closing femoral veins. I feel confident that this indication will change the way interventionists and electrophysiologists approach venous access sites, enabling them to close their more complex cases on the table, and thereby helping to increase efficiency and throughput in busy interventional laboratories.” Dr. Srivatsa is Director of the Heart Artery and Vein Center in Fresno, California.