Medinol Begins Study for its Drug-Eluting Peripheral Stent System

Surgeons have implanted Medinol Ltd.’s ChampioNIR Drug-Eluting Peripheral Stent in a (human) patient for the first time, thus initiating the CHAMPIONSHIP trial, the company reported.

Drs. Gerard S. Goh and Thodur Vasudevan of the Alfred Hospital in Melbourne, Australia, conducted the procedure. “We were impressed with ChampioNIR’s deliverability and its straightforward deployment,” said Dr. Goh, head of Interventional Radiology at The Alfred Hospital. “The frictionless deployment mechanism made the precise positioning of the stent very straightforward.”

The ChampioNIR Drug-Eluting Peripheral Stent System poses a transformational technology designed to improve patient outcomes and procedural success. In a first-of-its-kind hybrid mechanical design, radial support is provided by the stent’s metallic component, whereas longitudinal structure is provided by a bioresorbable polymeric mesh providing unsurpassed flexibility and long-term durability in even the most challenging anatomies. Furthermore, a unique drug-elution paradigm releases drug from the stent’s entire cylindrical area, drastically reducing diffusion distances and allowing for the first time therapeutic dosing of a large peripheral vessel with a “limus” drug for an extended period of time.

“Medinol is excited to bring to clinical practice the culmination of years of research and development into novel stent designs, tailor-made for unmet clinical challenges in vascular interventions,” Medinol CEO Dr. Yoram Richter stated.

The CHAMPIONSHIP First In Human study will enroll 30 patients across seven sites in Australia and the United States. “The ChampioNIR stent represents a breakthrough in treatment for SFA lesions. I am excited to see this device come to life after years of development,” CHAMPIONSHIP study principal investigator Prof. Sahil Parikh commented.

Founded in 1992, Medinol is a privately held company with offices in the United States and Israel, employing more than 300 workers. Extending more than 30 years of experience in the stent market, Medinol is aggressively changing paradigms in the ways in which disease states are diagnosed and treated. The firm designs cutting-edge scaffolds for stenting multiple areas of the human body, which dramatically reduce complications in structural heart procedures, and provide real-time insights into physiological metrics through implantable microsensors.