Medical 21 has received regulatory approval in Spain under the European Union Medical Device Regulation (EU MDR) to initiate the company’s first-in-human, multicentre clinical trial of the Maverics graft—a novel regenerative small-diameter coronary bypass graft—the MAVERICS coronary revascularization study.
The Maverics graft is described by Medical 21 as a next-generation regenerative vascular scaffold engineered to address the long-standing challenge of creating durable, small-diameter conduits for coronary artery bypass grafting (CABG). Its design integrates an absorbable polymeric scaffold with a nitinol wire frame, combining early mechanical support with a structure intended to guide the patient’s natural healing process. The scaffold architecture is designed to encourage cellular infiltration, neovascularisation, and the gradual formation of native vascular tissue.
By providing a consistent, readily available alternative to harvested vessels, the Maverics graft aims to streamline CABG procedures, reduce harvest-related morbidity, and broaden revascularisation options for patients requiring coronary bypass surgery.
“We are pleased to have received all necessary regulatory clearances in Spain to begin our first-in-human study,” said Manny Villafaña, chief executive officer of Medical 21. “This milestone marks an important step forward in validating the clinical potential of the Maverics graft and advancing our mission to transform coronary bypass surgery. For decades, surgeons have faced limitations in available conduit quality and quantity. The Maverics graft is designed to address these longstanding challenges, and we are eager to begin assessing its safety, performance, and biological integration in patients.”
The Maverics graft is an investigational device and has not been approved for commercial sale by the US Food and Drug Administration (FDA) or any other regulatory authority.
