Shockwave Launches C²⁺ IVL Catheter Internationally, Commences All-Female EMPOWER CAD Study

May 15, 2023—Shockwave Medical, Inc. announced the full commercial availability in select international markets of the Shockwave C²⁺ coronary intravascular lithotripsy (IVL) catheter. The device is now available for the treatment of severely calcified de novo coronary artery disease in Europe and select other geographies.

According to the company, Shockwave C²⁺ provides 50% more pulses per catheter than Shockwave C² and is designed to treat longer calcified lesions and more challenging eccentric and nodular calcium.

Jonathan Hill, MD, consultant cardiologist at the Royal Brompton Hospital in London, United Kingdom, commented in the company’s press release, “Shockwave C²⁺ maintains the intuitive catheter design and ease of use that are foundational to the success of Shockwave IVL and incorporates improvements that will enhance procedural efficiency and optimize the treatment of the most challenging morphologies. The extra pulses are most advantageous in areas with the highest burden of calcium, including nodular, eccentric, diffuse, and multivessel calcium.”

Also, Shockwave Medical announced enrollment of the first patient in EMPOWER CAD, the first prospective, all-female study of percutaneous coronary intervention. The company first announced the trial at TCT 2022, the 34th annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held September 16-19 in Boston, Massachusetts.

According to the company, the study seeks to confirm the benefits of coronary IVL in female patients with calcified lesions, a group that historically has experienced less favorable clinical outcomes than male patients with traditional therapies. The Coprincipal Investigators for EMPOWER CAD are Margaret McEntegart, MD, and Alexandra Lansky, MD.

Dr. McEntegart is Director of the Complex Percutaneous Coronary Intervention Program at Columbia University Medical Center/New York-Presbyterian Hospital in New York, New York. Dr. Lansky is Professor of Medicine, Section of Cardiovascular Medicine and Director of the Heart and Vascular Clinical Research Program at Yale University School of Medicine in New Haven, Connecticut.

The study’s European lead is Nieves Gonzalo, MD, consultant interventional cardiologist at Hospital Clinico San Carlos in Madrid, Spain.

The first patient in EMPOWER CAD was enrolled by Richard A. Shlofmitz, MD, who is Chairman of the Department of Cardiology at St. Francis Hospital in Roslyn, New York.

Dr. McEntegart, who attended the first procedure performed by Dr. Shlofmitz, commented in the company’s press release, “We are excited to initiate enrollment of the EMPOWER CAD study, the first prospective clinical study in the interventional space that is completely dedicated to female patients. This is a major step toward better understanding the optimal strategy for calcium modification in female patients, an underrepresented patient population who frequently are more challenging to treat and often experience suboptimal outcomes.”