Healthcare Industry News: Patent Foramen Ovale
News Release - September 22, 2009
Coherex Medical Signs Exclusive Distribution Agreement with AbbottAbbott to market, sell and distribute the Coherex FlatStent EF PFO Closure System
SALT LAKE CITY--(HSMN NewsFeed)--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(TM) 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.
About Patent Foramen Ovale (PFO) Heart Defects
A foramen ovale is a tunnel-like opening between the upper chambers of the heart that allows blood to bypass the lungs while a fetus is in the womb. Normally, the foramen ovale closes soon after an infant is born. However, if this opening fails to close naturally after birth, the opening is said to remain patent and the condition is called a Patent Foramen Ovale (PFO) – a common heart defect that occurs in approximately 20 percent of the population.
Under certain conditions, a PFO may allow blood to bypass the lungs and shunt directly from the right side of the heart to the left. Since the lungs normally filter all blood flowing through the body, such shunting may allow unfiltered blood clots and other components to travel directly to the brain or other regions of the body.
About Coherex Medical
Formed in 2003, Coherex Medical is focused on addressing structural heart disease and conditions through the development of innovative medical devices. Venture capital investors in Coherex include Oxford Bioscience Partners, vSpring Capital, and Tullis HEALTH Investors. For more information, please visit www.coherex.com or call 801-433-9900.
NOTE: The Coherex FlatStent EF PFO Closure System is not approved for use in the United States, but it is available for use in countries that accept CE Mark clearance.
Coherex Medical and Coherex FlatStent are trademarks of Coherex Medical, Inc. All other trademarks are the properties of their respective owners.
Source: Coherex Medical
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