Cardinal Health MynxGrip Vascular Closure Device receives Food and Drug Administration approval for venous indication
DUBLIN, Ohio, Nov. 4, 2014 — Cardinal Health today announced that its MynxGrip® Vascular Closure Device recently received Food and Drug Administration approval for use to close femoral veins. The MynxGrip device is now indicated for use to seal 5F, 6F and 7F femoral arterial and femoral venous access sites.
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 MynxGrip device is intended to reduce times to hemostasis and ambulation, thereby potentially shortening post-procedure recovery times.
The MynxGrip Vascular Closure Device utilizes the proprietary, 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.
"The gentle deployment and secure extravascular sealant make the MynxGrip device an excellent option for closing femoral veins,” said Dr. Sanjay Srivatsa, director, Heart Artery and Vein Center, Fresno, Calif. “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."
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.
Dr. Shaden Marzouk, vice president of Clinical Affairs for Cardinal Health noted, "The venous indication for the MynxGrip Vascular Closure Device is an example of innovative applications for an interventional suite offering that is differentiated in the marketplace. We know that these high quality, value-priced and patient-centered solutions are extremely important in today's evolving health care landscape."
Cardinal Health will feature the MynxGrip Vascular Closure Device at its booth at the Vascular Interventional Advances annual conference in Las Vegas Nov. 4- 7.
The Mynx product family of devices is clinically proven and has been featured in several peer-reviewed articles. More articles and information can be found on Cardinal Health’s AccessClosure website, www.accessclosure.com.
About Cardinal Health
Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a $91 billion health care services company that improves the cost-effectiveness of health care. As the business behind health care, Cardinal Health helps pharmacies, hospitals, ambulatory surgery centers, clinical laboratories and physician offices focus on patient care while reducing costs, enhancing efficiency and improving quality. Cardinal Health is an essential link in the health care supply chain, providing pharmaceuticals and medical products and services to more than 100,000 locations each day and is also the industry-leading direct-to-home medical supplies distributor. The company is a leading manufacturer of medical and surgical products, including gloves, surgical apparel and fluid management products. In addition, the company operates the nation's largest network of radiopharmacies that dispense products to aid in the early diagnosis and treatment of disease. Ranked #22 on the Fortune 500, Cardinal Health employs 34,000 people worldwide. More information about the company may be found at www.cardinalhealth.com and @CardinalHealth on Twitter.