Vascular closure device receives FDA approval for venous indication

The FDA has approved a new indication for a vascular closure device that enables its use for the closure of femoral arterial and femoral venous access sites, according to a press release.

The MynxGrip Vascular Closure Device (Cardinal Health) is now indicated for use to seal 5F, 6F and 7F femoral arterial and femoral venous access sites. The device features a proprietary, extravascular sealant intended to adhere to the vein to aid in mechanical closure and dissolve within 30 days. According to the release, use of the device can shorten patient recovery time by reducing time to hemostasis and ambulation. The MynxGrip is also intended to improve efficiency and reduce complications by eliminating the need for manual compression.

The company will send updated instructional documents and patient brochures to all current users of the device, who will immediately be able to begin using the MynxGrip for its new indication, according to the release.

“I feel confident that this indication will change the way interventionalists 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,” Sanjay Srivatsa, MD, director of the Heart Artery and Vein Center in Fresno, Calif., said in the release.