Novel Stent Closes Patent Foramen Ovale From Within

An innovative Patent Foramen Ovale (PFO) closure system redefines the concept of a stent, using outward-directed force to close a structure, instead of outward expansion forces to open it.

The FlatStent EF is designed to combine the familiarity and ease-of-use of a self-expanding vascular stent with a unique fusion of PFO closure technologies. Rapid-exchange functionality simplifies device delivery and maintains wire access throughout the procedure. The Flatstent is designed to provide three distinct closure mechanisms; a lateral force exerted by the deployed stent to close the tunnel from within; a foreign body response to the implant to stimulate endothelial formation; and a polymer substrate to promote cellular integration within the tunnel. The mechanism of action of the FlatStent EF is also intended to limit the incidence of other major complications associated with septal patching devices currently in use, such as erosion, persistent arrhythmia, and valve apparatus distortion. Additionally, the implanted stent leaves a minimal amount of material exposed in the left atrium to reduce the risk of thromboembolism. The FlatStent EF is under development by Coherex Medical (Salt lake City, UT, USA) and is currently being used exclusively for clinical investigations in Europe and Australia.

"The Coherex FlatStent marks the beginning of a new era of medical device technology and significantly raises the bar by providing a simple and safe alternative in PFO closure for physicians and their patients," said Horst Sievert, M.D., a professor of internal medicine, cardiology, and vascular medicine at the Cardiovascular Center (Frankfurt, Germany), who completed the first human cases of the FlatStent PFO Closure System.

PFO is a common condition (affecting about 25% of the population) in which a hole that connects the two upper chambers of the heart (atria) during fetal development fails to close properly after birth. The PFO functions like a flap valve, opening under increased pressure that occurs when people strain while having a bowel movement, cough, or sneeze. If the pressure is great enough, blood may travel from the right atrium to the left atrium. If there is a clot or particles in the blood traveling in the right side of the heart, it can cross the PFO, enter the left atrium, and travel out of the heart and to the brain (causing a stroke) or into a coronary artery (causing a myocardial infarction).

Related Links:
Coherex Medical
Cardiovascular Center