Author + information
- Received March 30, 2010
- Accepted April 5, 2010
- Published online September 1, 2010.
- Wibke J. Zimmermann, MD,
- Corinna Heinisch, MD,
- Nicolas Majunke, MD,
- Stephan Staubach, MD,
- Scott Russell,
- Nina Wunderlich, MD and
- Horst Sievert, MD⁎ ()
- ↵⁎Reprint requests and correspondence:
Dr. Horst Sievert, CardioVascular Center Frankfurt, Seckbacher Landstrasse 65, 60389 Frankfurt, Germany
Objectives The purpose of this study was to evaluate the safety and effectiveness of the SeptRx patent foramen ovale (PFO) closure device (SeptRx, Inc., Fremont, California).
Background A PFO is a relatively common remnant of the fetal circulation that can be associated with cryptogenic stroke, transient ischemic attack, migraine, or decompression sickness. Percutaneous PFO closure with different devices has been performed for many years. However, most of the common devices leave a relatively large amount of material in the left and right atria. The SeptRx PFO device (SeptRx, Inc.) is the first PFO closure device designed to fit directly into the pocket of the PFO.
Methods From July 2006 to May 2007, 13 patients between 18 and 65 years of age with a history of cryptogenic stroke or transient ischemic attack were included into this first-in-man trial. All patients received 100 mg aspirin and 75 mg clopidogrel for 6 months. Follow-up was done at 1 and 6 months after procedure with transesophageal echocardiography and transcranial Doppler.
Results In 11 of 13 patients, PFO closure with the SeptRx device was successfully performed. In 2 patients, PFO closure with this device was not possible due to the anatomy of the PFO; 1 device was retrieved before release, and the other was recaptured with a snare. After 30 days, 6 of the 11 PFOs were closed; after 6 months, all were closed. No adverse events occurred.
Conclusions The SeptRx PFO closure device appears to be safe and effective. The advantage of this occluder is that there is only minimal foreign material on the left and right sides of the interatrial septum. This is the first such “in-tunnel” PFO closure device.
Dr. Russell is an employee of SeptRx, Inc. Dr. Sievert has received consulting fees, travel expenses, and/or study honoraria from Abbott, Access Closure, AGA, Angiomed, Ardian, Arstasis, Avinger, Boston, Bridgepoint, CardioKinetix, CardioMEMS, Coherex, Cordis, CSI, Edwards, EndoCross, EndoTex, ev3, FlowCardia, Gore, Guidant, Invatec, Lumen Biomedical, Kensey Nash, Kyoto Medical, Medtronic, Nitinol Devices and Components (NDC), NMT, OAS, Occlutech, Osprey, Ovalis, Pathway, pfm, PendraCare, Percardia, Remon, Rox Medical, Sadra, Sorin, Spectranetics, SquareOne, St. Jude, Terumo, Viacor, Velocimed, Xtent, Cardiokinetix, Access Closure, Coherex, Velocimed, CoAptus, and Lumen Biomedic. All other authors report that they have no relationships to disclose.
- Received March 30, 2010.
- Accepted April 5, 2010.
- American College of Cardiology Foundation