MINNEAPOLIS, Jan. 6 /PRNewswire/ -- Velocimed LLC, (a privately held company) announces today that is has received the CE Mark for the Premere(TM) PFO Closure System, an innovative, new transcather PFO closure device offering superior conformability and greater placement control, for more confident closure of a patent foramen ovale.
A patent foramen ovale is a flap-like opening in the atrial septum that fails to close after birth in approximately 25%-30% of the population. Under certain circumstances, this flap-like opening may allow emboli to abnormally shunt from the right to the left atria, increasing the risk of ischemic stroke. Several studies have demonstrated a significantly higher incidence of PFO in patients suffering from cryptogenic stroke (40%-50%), as compared to the incidence found in the general population (25%-30%). Transcatheter closure of a PFO in patients suffering from cryptogenic stroke has been a growing practice in many parts of the world for the past 8-10 years.
Premere, the Latin translation meaning "to press together", is a novel device designed to redefine PFO closure. Consisting of two flexible, low profile, nitinol anchors connected via an adjustable length polyester tether, the Premere PFO Closure System is uniquely designed to adapt to the individual anatomy of each patient, maximizing closure success while minimizing risk of procedural complications. This first-of-its-kind design enables greater placement control during device deployment. The flexible, low profile anchors are designed to conform seamlessly to the septal wall to "hold the door shut", promoting rapid endothelialization and closure of the PFO. The Premere PFO Closure System will be available in three sizes: 15mm, 20mm, and 25mm.
The CLOSEUP clinical trial demonstrated the safety of the Premere PFO Closure System in 67 patients, each of whom received the implant at one of five centers located in either Germany or Switzerland. The primary endpoint of the study was achieved with 100% of patients free from serious adverse events, including thrombus formation, atrial fibrillation, device fracture, embolization, erosion, infection, recurrent stoke, or death.
Professor Horst Sievert of the Cardiovascular Center Sankt Katharinen in Frankfurt, Germany, was the Principal Investigator of the CLOSEUP clinical trial. "I am impressed by the good results that we experienced with the Premere system at my center," said Professor Sievert. "The ability to adapt the device to each patient minimizes septal distortion, promoting acute closure of the PFO. This device has an extremely low profile. Additionally, the absence of a covering on the left anchor is a significant benefit to patients, minimizing the risk of thrombus formation in the left atrium."
Commenting on the recent product approval, Dennis Wahr, President and CEO of Velocimed said, "We are very excited to receive the CE mark for the Premere PFO Closure System and to have the opportunity to offer cardiologists a new alternative for PFO closure. The Premere System has been thoughtfully designed to address the unique anatomy of the patent foramen ovale, offering a superior combination of features that benefit both implanting physicians and their patients."
The Velocimed Premere PFO Closure System is the first in a series of septal closure devices that Velocimed is developing for use in repair of congenital heart defects.
Minneapolis-based Velocimed ( http://www.velocimed.com/ ) is a developer, manufacturer and marketer of medical devices whose products will be used in a broad range of interventional cardiology and neurology applications.
This press release contains forward-looking statements. The Company wishes to caution the reader of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with litigation, clinical trials, the regulatory approval process, reimbursement policies and commercialization of new technologies.