Cardiva Medical wins expanded FDA indications for Vascade vascular closure system

Cardiva Medical said today it won expanded indications from the FDA for its Vascade vascular closure system, now cleared for use in 5-7F femoral venous closures in addition to arterial closure.

The Vascade system is composed of a thrombogenic bioabsorbable collagen patch and a collapsible mesh disc, the Santa Clara, Calif.-based company said.

The device functions by placing a collapsible mesh disc against the inner vessel wall to stop bleeding followed by a collagen patch and the removal of the mesh disc, the company said. The collagen patch is designed to expand, seal and stop bleeding and is later absorbed by the body.

“This expanded indication is an exciting milestone for Cardiva Medical, as it expands our market potential and further differentiates our company and our innovative technology. We are pleased that the new indication will allow us to extend the proven benefits of Vascade closure to a broader group of patients,” Cardiva prez & CEO John Russell said in a press release.

The approval came supported by data from a clinical trial of the Vascade device exploring its use in venous closure procedures, Cardiva said. Results from the 420-patient trial indicated that the device was able to achieve complete hemostasis without vascular complications, the company said.

“Vascade has performed exceptionally well for our current patients, and this new indication will empower many physicians to use Vascade for vein closure. Successful vessel closure, and enabling a patient to walk as soon as possible after their procedure, are critical factors for recovery from interventional procedures. The ease of use of the Vascade system and its compelling clinical data will make it an attractive new option for closure following vein procedures,” Dr. Joseph De Gregorio at New Jersey’s Englewood Hospital and Medical Center said in a prepared statement.

In February, Cardiva Medical said it added another $11 million to a funding round it closed last year at $30 million to continue the commercialization of its Vascade vascular closure device.

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