Medical 21, Inc. Gains Approval for Groundbreaking Clinical Study
Regulatory clearance enables launch of the MAVERICS Coronary Revascularization Study, advancing evaluation of the Company's next-generation synthetic small-diameter bypass graft.
Medical 21, Inc., a pioneering medical technology company, has received regulatory approval in Spain. This is a notable achievement under the European Union Medical Device Regulation (EU MDR), allowing the company to kickstart its first-in-human clinical trial titled the MAVERICS Coronary Revascularization Study.
The MAVERICS graft symbolizes a leap forward in regenerative vascular technology. This innovative small-diameter bypass graft is skillfully crafted to tackle the persistent issue of creating robust conduits for coronary artery bypass grafting (CABG). Its unique design features an absorbable polymeric scaffold complemented by a nitinol wire frame, which aims to provide immediate mechanical support while fostering the body’s natural healing process.
The architectural integrity of the MAVERICS graft is engineered to promote cellular infiltration, induce neovascularization, and facilitate the gradual development of native vascular tissue. This graft is more than just a conduit; it represents a reliable and available alternative to traditional harvested vessels. As a result, it looks to simplify CABG procedures, decrease the complications associated with vessel harvesting, and widen the revascularization options available to patients in need of coronary artery bypass surgery.
Dr. Manny Villafaña, Ph.D. Sc., the Chief Executive Officer of Medical 21, expressed his enthusiasm about this milestone. He stated, "We are delighted to have obtained all the necessary regulatory approvals to launch our first-in-human study. This landmark event marks crucial progress in confirming the clinical promise of the MAVERICS graft and furthers our commitment to revolutionizing coronary bypass surgery. For many years, surgeons have encountered hurdles with the quality and quantity of available conduits. The MAVERICS graft is poised to overcome these longstanding challenges, and we are excited to assess its safety, performance, and biological integration in patients."
It is critical to note that the MAVERICS graft currently remains an investigational device and has yet to receive approval for commercial sale by the U.S. Food and Drug Administration (FDA) or any other regulatory entity.
About Medical 21, Inc.
Medical 21, Inc. is committed to transforming cardiac bypass surgery through its innovative technologies. The company’s MAVERICS regenerative platform includes its flagship product—the MAVERICS coronary graft, designed specifically to serve as a small-diameter vascular conduit and eliminate the necessity for vessel harvesting during CABG procedures. The headquarters of Medical 21 is situated in Minneapolis, Minnesota.
Frequently Asked Questions
What is the MAVERICS Coronary Revascularization Study?
The MAVERICS Coronary Revascularization Study is a first-in-human clinical trial designed to evaluate the safety and performance of the MAVERICS graft.
What is the purpose of the MAVERICS graft?
The MAVERICS graft is created to provide a durable, small-diameter conduit for coronary bypass procedures, addressing longstanding challenges in CABG.
Who is Medical 21, Inc.?
Medical 21, Inc. is a medical technology company specializing in innovative solutions for cardiac bypass surgery.
What regulatory approval has Medical 21, Inc. received?
Medical 21, Inc. has received regulatory clearance in Spain to commence its first-in-human clinical trial for the MAVERICS graft.
Is the MAVERICS graft commercially available?
Currently, the MAVERICS graft is an investigational device and has not yet been approved for commercial sale by the FDA or other regulatory bodies.
