About Us

MISSION
We are a medical device company which develops and markets products that enable minimally invasive cardiovascular procedures. From pioneering percutaneous techniques for the correction of congenital heart defects, to designing the first bioabsorbable occlusive devices, our ingenuity is what guides us. We are committed to reducing costs to provide more sustainable and accessible health care. Innovation and quality are the cornerstones of our business culture, as we strive to improve outcomes for patients, worldwide.

HISTORY
The foundation of Custom Medical Devices was established in the late 1980s with the development of the Buttoned Device. At the time, surgery was the only established technique for the correction of heart defects. The Buttoned Device offered an alternative, which enabled treatment through a minimally invasive operation. The first prototype was developed in Amarillo, Texas and was tested in experimental heart defects in piglets. Eventually, our data was presented in a National American Heart Association meeting in 1988. This presentation generated a lot of interest among Pediatric Cardiologists. Physicians came from around the country to learn the technique, and an FDA approved trial ensued. At the same time, interest was generated in Europe and Asia, and International Clinical trials were initiated with the Buttoned Device. Excellent results from these trials, along with the multitude of physicians who were trained in the procedure, helped to establish percutaneous closure of heart defects as the preferred treatment option.
There was a continuous effort to improve the original device with the progressive development of four generations. FDA clinical trials with the buttoned device were complete in 1997 with excellent results and we were ready for pre-market approval the same year. The centering on demand buttoned device followed with clinical trials in the US and in Europe. Despite the success of the Buttoned Device and other metallic devices there were rare problems related to the metal, including perforations, fractures, and embolizations.
We started working with wireless bio-absorbable devices in 1998. We first developed a partially bio-absorbable, detachable balloon device, followed by the fully bio-absorbable Transcatheter Patch. The Transcatheter Patch not only pioneered bio-absorbable occlusive devices, with the first in man implanted successfully in 1999, but it also found applications in many heart defects and diseases where metal devices could not be used. Such conditions include Fallot Tetralogy, the ostium primum ASD, and the sinus venosus ASD.

PEOPLE
Dr. Sideris has formerly been an assistant professor at the University of California, Texas Tech and an associate professor at the University of Texas. He is a practicing pediatric cardiologist who pioneered the use of minimally invasive occlusive devices in the late 1980’s. After founding Custom Medical Devices, his ingenuity has ensured that our products are on the cutting edge and that we constantly improve outcomes for our patients. He has made significant contributions to interventional cardiology, especially in congenital heard disease, and continues to lead our development of innovative devices and procedures.
Our team consists of a group of highly motivated and talented people working in the fields of engineering, marketing, business administration, and product development.