Salt Lake City-based Coherex Medical, Inc. today announced that it has entered into a multi-year distribution agreement with global health care company Abbott for the Coherex FlatStent™ EF PFO Closure System.
The Coherex FlatStent EF device is designed to close Patent Foramen Ovale (PFO), a common structural heart defect found in approximately 20 percent of the worldwide population, using a percutaneous catheter-based approach. Some patients with clinical conditions including stroke and chronic migraine may benefit from PFO closure.
Under terms of the agreement, Coherex will provide marketing, sales and distribution rights to Abbott for the CE-marked Coherex FlatStent EF in all countries worldwide except for the United States and Japan. Coherex Medical will manufacture the Coherex FlatStent EF PFO Closure System at its facility in Salt Lake City. Financial terms of the agreement were not released.
“I am proud to say Coherex has accomplished several major objectives in recent months,” said Richard J. Linder, Coherex President and CEO. “First, we announced that the Coherex FlatStent EF PFO Closure System had received CE Mark clearance. Then we closed on a $16.5 million Series B Preferred Stock financing. And now we are partnering with Abbott in a distribution agreement to market and sell our PFO closure device in many countries throughout the world. Abbott’s global reach and cardiovascular expertise are impressive. I am pleased Coherex is entering into this distribution agreement with Abbott.”
Coherex announced in July that its Coherex FlatStent EF PFO Closure System had received CE Mark clearance for closing PFO, making it the first “in-tunnel” device to be granted clearance by any regulatory body. With CE Mark clearance, the Coherex FlatStent can be marketed and sold in more than 25 countries in Europe, as well as other countries outside of Europe. Coherex plans to conduct additional clinical trials in the future, designed to lead to eventual approval in the USA and Japan.