Simultaneously the company introduced to the international market their latest iteration of the calcium-cracking coronary catheter: the C2+ which affords greater numbers of pulses to treat longer and more challenging lesions. Additionally Shockwave announced that the first patient had been enrolled in the EMPOWER study of the treatment of calcified lesions in women, who historically have had less favorable outcomes in the treatment of coronary artery disease. You can read more about the EMPOWER study here.
Lithotripsy was originally invented as a treatment for kidney stones: a way to pulverize and eliminate these obstructions without surgery. Shockwave Medical took this technology into the peripheral vessels to treat PAD and ultimately into the coronary arteries to afford a safe and relatively simple method to solve the problem of calcified lesions which were historically complicated to treat. The result is that interventional cardiologists are able to deal with this lesion subset successfully with a device that requires a very short learning curve.
Shockwave Medical Launches New Coronary IVL Catheter Internationally and Enrolls First Patient in All-Female Empower Study
Shockwave C2+ Catheter Expands Utility of IVL in Calcified Coronary Arteries
May 15, 2023 -- Santa Clara, California -- Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development and commercialization of transformational technologies for the treatment of cardiovascular disease, today announced the full commercial availability of the Shockwave C2+ Coronary Intravascular Lithotripsy (IVL) Catheter to treat severely calcified coronary artery disease in select international markets. Shockwave C2+ provides 50 percent more pulses per catheter than Shockwave C2 and is optimally designed to treat longer calcified lesions and more challenging eccentric and nodular calcium.
Dr. Jonathan Hill |
“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,” said Jonathan Hill, MD, Consultant Cardiologist at the Royal Brompton Hospital in London. “The extra pulses are most advantageous in areas with the highest burden of calcium, including nodular, eccentric, diffuse and multivessel calcium.”
First Patient Enrolled in EMPOWER CAD
Shockwave Medical also announced enrollment of the first patient in EMPOWER CAD, the first prospective, all-female study of percutaneous coronary intervention, seeking to confirm the benefits of coronary IVL in female patients with calcified lesions, who historically have experienced less favorable clinical outcomes than male patients with traditional therapies. The first patient was enrolled by Richard A. Shlofmitz, MD, Chairman, Department of Cardiology, St. Francis Hospital in Roslyn, New York.
Drs Margaret McEntegart and Richard Shlofmitz |
“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,” said Margaret McEntegart, MD, PhD, Director of Complex Percutaneous Coronary Intervention Program at Columbia University Medical Center/New York-Presbyterian Hospital and co-principal investigator of EMPOWER CAD, after she attended the first case performed by Dr. Shlofmitz. “This is a major step towards better understanding the optimal strategy for calcium modification in female patients, an under-represented patient population who frequently are more challenging to treat and often experience suboptimal outcomes.”
The co-principal investigators for EMPOWER CAD are Margaret McEntegart, MD, PhD, and Alexandra Lansky, MD, Professor of Medicine, Section of Cardiovascular Medicine and Director, Heart and Vascular Clinical Research Program at Yale University School of Medicine. The study’s European lead is Nieves Gonzalo, MD, PhD, Consultant Interventional Cardiologist at Hospital Clinico San Carlos in Madrid, Spain.
Shockwave C2+ is commercially available for the treatment of de novo coronary artery disease in Europe and select other geographies.
About Shockwave Medical
Shockwave Medical is a leader in the development and commercialization of innovative products that are transforming the treatment of cardiovascular disease. Its first-of-its-kind Intravascular Lithotripsy (IVL) technology has transformed the treatment of atherosclerotic cardiovascular disease by safely using sonic pressure waves to disrupt challenging calcified plaque, resulting in significantly improved patient outcomes. Shockwave has also recently acquired the Neovasc Reducer, which is under clinical investigation in the United States and is CE Marked in the European Union and the United Kingdom. By redistributing blood flow within the heart, the Reducer is designed to provide relief to the millions of patients worldwide suffering from refractory angina. Learn more at www.shockwavemedical.com and www.neovasc.com.
