Medical 21 Secures Approval for Innovative Coronary Graft Study

Medical 21, Inc., a private medical technology firm based in Minneapolis, has received regulatory approval in Spain to commence its first-in-human clinical trial for the MAVERICS graft. This significant advancement allows the company to launch the MAVERICS Coronary Revascularization Study, aimed at evaluating a next-generation synthetic small-diameter bypass graft.

The decision was made under the European Union Medical Device Regulation (EU MDR) and marks a vital step in the clinical validation of the MAVERICS graft. This innovative device is designed to address the persistent challenges associated with creating durable, small-diameter conduits for coronary artery bypass grafting (CABG).

Innovative Design for Improved Patient Outcomes

The MAVERICS graft features a unique regenerative vascular scaffold that integrates an absorbable polymeric scaffold and a nitinol wire frame. This design provides early mechanical support while facilitating the patient’s natural healing process. The scaffold architecture promotes cellular infiltration, neovascularization, and the gradual formation of native vascular tissue.

By offering a reliable and accessible alternative to harvested vessels, the MAVERICS graft aims to enhance CABG procedures. It is expected to reduce complications related to vessel harvesting and expand revascularization options for patients undergoing coronary bypass surgery.

Dr. Manny Villafaña, Ph.D. Sc., the Chief Executive Officer of Medical 21, expressed his enthusiasm regarding the approval, stating, “We are pleased to have received all necessary regulatory clearances in Spain to begin our first-in-human study. 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.”

He highlighted the historical limitations faced by surgeons regarding the quality and quantity of available conduits, emphasizing that the MAVERICS graft is designed to overcome these challenges.

Regulatory and Developmental Context

The MAVERICS graft is currently classified as an investigational device and has not yet received approval for commercial sale from the U.S. Food and Drug Administration (FDA) or any other regulatory body. The clinical trial will assess the safety, performance, and biological integration of the graft in patients, with the potential for significant implications for cardiac surgery.

Medical 21, Inc. is focused on reshaping the future of cardiac bypass surgery. Its MAVERICS regenerative platform seeks to eliminate the need for vessel harvesting in CABG procedures through its first product, the MAVERICS coronary graft.

The company positions itself at the forefront of innovation in medical technology, dedicated to advancing solutions that enhance patient outcomes in complex surgical procedures.

For more information about Medical 21, Inc., visit their website at www.Medical21.com.