A Medical Device Daily

Kensey Nash (Exton, Pennsylvania) has reported that it is in the process of responding to requests from the FDA with respect to its 510(k) application for the TriActiv System and seeking, the company said, “labeling and clarification of previously submitted data.“

The company said it is in touch with the agency and submitted its responses last week.

Joe Kaufmann, president and CEO, called the firm's dialogue with the FDA “very helpful and constructive, and we believe the few remaining items will be resolved satisfactorily.“

The TriActiv System is an embolic protection system designed to prevent material or debris, dislodged during stent procedures, from embolizing downstream and causing adverse coronary events such as a heart attack.

Expressing confidence in product approval, Kaufman said that the company has hired new sales staff, with the goal of having 10 added by March.

“Our discussions with the FDA have been moving forward and we are looking forward to a product launch in the near term,“ Kaufman said.

The company's application supporting a 510(k) clearance contains data from the PRotection during saphenous vein graft Intervention to prevent Distal Embolization (PRIDE) trial which randomized the TriActiv System against other approved embolic protection systems or the standard of care and measured major adverse cardiac event rates in the treatment of saphenous vein graft disease.

The TriActiv system is comprised of three integrated features: an embolic protection balloon, and a combined active flush and extraction system to remove the problematic debris from a target vessel. The system is commercialized in the European Union.

Kensey Nash manufactures absorbable biomaterials-based products with applications in the cardiology, orthopedics, spine, drug and biologics delivery, periodontal/dental, surgical and wound care markets