The GORE Septal Occluder, a cardiac implant made by W.L. Gore and Associates, has won the Best in Show Award at the 2013 Medical Design Excellence Awards (MDEA).
|The GORE Septal Occluder is manufactured by W. L. Gore & Associates Inc. (Flagstaff, AZ).|
The implant prevents shunting of the blood between the right and left atria in the treatment of congenital heart defects of the atrial septum and for closure of a flap valve in the atrial septum that is thought to be a risk factor for stroke.
Delivered via a transcatheter-approach, the device covers the defect with an ePTFE occlusive membrane supported by a Nitino wire frame. The septal occluder’s delivery system is composed of a 75 cm working length 10 Fr outer diameter delivery catheter, a control catheter, and a mandrel coupled to a handle. The device is deployed and repositioned by moving a slider on the handle.
As the patient’s body heals, tissue attaches to and covers the membrane, which helps to stabilize the implant. “Over time, the device will become completely covered with the patient’s own tissue,” according to the company’s MDEA submission.
Jurors gave the GORE Septal Occluder high marks in all five categories—design and engineering innovations, functional innovations, patient benefits, business benefits, and improvement to overall healthcare. Juror Balakrishna Haridas, president and founder of biomedical engineering consulting firm Device & Implant Innovations, called out the device’s “high degree of engineering innovation.” And juror Craig D. Friedman, a board-certified facial plastic surgeon and biomedical device consultant, noted the device’s “one-handed deployment.”
“Simplified motions allow less experienced physicians, such as interventional cardiologists, to easily implant the device,” the company wrote in its MDEA submission.
The GORE Septal Occluder also provides a number of benefits for patients. Because the procedure is performed via transcatheter, patients have a shorter hospital stay (overnight versus two days to one week), reduced scarring, and an easier, faster recovery than if they had surgery. The product also reduces procedural time, minimizing patients' exposure to anesthesia and radiation, and cutting hospital costs.
W.L Gore was granted FDA approval to use the GORE Septal Occluder in a clinical study in October 2012. The device is commercially available in the EU and Canada (under special access).
—Jamie Hartford is the managing editor of MD+DI.