Cordis Announces Successful First-in-Human Use of the Radianz Radial Peripheral System

Successful procedures initiate U.S. limited market release

Miami Lakes, FL – June 17, 2022 — Cordis announced the first-in-human use of the Radianz Radial Peripheral System™ by Jihad Mustapha, MD, FACC, FSCAI at Advanced Cardiac & Vascular Centers (ACV) in Grand Rapids, Michigan.

The Radianz Radial Peripheral System™ solution includes BRITE TIP RADIANZ™ Guiding Sheath used to optimize lower extremity lesion access, the SABERX RADIANZ™ PTA Catheter to facilitate treatment, and the S.M.A.R.T. RADIANZ™ Vascular Stent System to help maintain patency for lasting favorable outcomes.

Radianz Radial Peripheral System™ is purposely engineered for radial access, which is proven to produce fewer vascular complications and higher patient satisfaction than femoral approaches.

According to Dr. Mustapha, Chief Executive Officer and Director of Endovascular Intervention at Advanced Cardiac & Vascular Centers (ACV) for Amputation Prevention,  “My colleagues at ACV and I are pleased to have successfully performed the first procedures using the Radianz Radial Peripheral System™, said Dr. Mustapha. “We believe this portfolio represents true innovation in meeting the need for radial access solutions for lower extremity intervention.”

Dr. Jihad Mustapha is recognized throughout the world as a pioneer for his groundbreaking work in critical limb ischemia, or CLI, which is marked by the severe obstruction of arteries, drastically reducing blood flow to the extremities. Left untreated, CLI can result in amputations.

"We are extremely pleased with the positive feedback from Dr. Mustapha and proud that these first-in-human cases were performed so successfully and by such a highly esteemed physician,” said Cordis CEO Shar Matin. "When used as a comprehensive treatment solution for vascular disease, we believe the unique capabilities of the Radianz Radial Peripheral System™ have the potential to positively impact outcomes and improve quality of life for patients.” 

Multiple studies have demonstrated overwhelming patient preference for radial versus femoral access. An 85% reduction in access site complications and reduction of major bleeding by 73% give insight into the 80% patient satisfaction rate. 

Studies show that patient ambulation time can be reduced from hours to minutes, and patients experience improved mobility and comfort from the outset. Radial approaches provide post-procedure complications of less than 1% compared to 2% to 4% with femoral access.

In addition to the well-documented clinical benefits of the Radianz Radial Peripheral System™, radial access can reduce the total cost of care. A systematic review of 14 randomized controlled trials found radial access lowered hospital costs in the U.S. up to $1,116 per procedure in duration-of-stay costs compared to femoral access. 

The Radianz Radial Peripheral System™ portfolio is expected to launch later this year in the U.S. and in the near future in Japan. 

About Cordis

Cordis is a worldwide leader in the development and manufacturing of interventional vascular technology with a more than 60-year history of pioneering breakthrough cardiovascular technologies to treat millions of patients. With a reputation for clinical acumen, training, and service, Cordis established a legacy of innovation in high-quality and less-invasive cardiovascular products and built a strong global footprint with operations in more than 70 countries around the world.

About Dr. Mustapha

Jihad Mustapha, MD, FACC, FSCAI is a board-certified interventional cardiologist specializing in endovascular revascularization of PAD, specifically CLI. He serves as Clinical Associate Professor of Medicine at Michigan State University College of Osteopathic Medicine and is a Founder and Director of the AMPutation Prevention Symposium as well as a Founding Board Member of the CLI Global Society.

Dr. Jihad Mustapha developed the notion early in his practice that a device to unblock arteries leading to the heart might be used to perform the same thing for legs. Known in some circles as "The Leg Saver,” Dr. Jihad Mustapha performs artery and vein catheterizations that open up blocked vessels to improve circulation and reduce the need for amputations.

About Advanced Cardiac & Vascular Centers^© (ACV)

Launched in February 2018, Advanced Cardiac & Vascular Centers (ACV) for Amputation Prevention provides highly personalized and comprehensive cardiac, vascular, and vein care. Co-founded by Dr. Jihad Mustapha and Dr. Fadi Saab, ACV Centers has a special concentration on treating peripheral artery disease and the complications of critical limb ischemia. For further information, visit www.acvcenters.com.