The company designed its C2+ coronary IVL catheter to treat severely calcified coronary artery disease. Santa Clara, California-based Shockwave, which has been subject to recent acquisition speculation, launched the catheter in select international markets.
Shockwave C2+ is commercially available for the treatment of de novo coronary artery disease in Europe and select other geographies.
Last month, Bloomberg reported that Boston Scientific had eyes on acquiring Shockwave. Last week, a Streetinsider.com report claimed interest from Medtronic and Johnson & Johnson as well. The reports came from anonymous sources. Both Medtronic and Shockwave declined to comment on the speculation.
The company said in a news release that its C2+ provides 50% more pulses per catheter than the previous C2 version. Its design enables the treatment of longer calcified lesions and more challenging, eccentric and nodular calcium.
“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 Dr. 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.”
Shockwave Medical shares clinical trial news, too
The company also announced the enrollment of the first patient in its EMPOWER CAD study. This marks the first prospective, all-female study of percutaneous coronary intervention (PCI), Shockwave said.
EMPOWER CAD aims to confirm the benefits of coronary IVL in female patients with calcified lesions. These patients historically experienced less favorable clinical outcomes than male patients with traditional therapies. Dr. Richard A. Shlofmitz of St. Francis Hospital in Roslyn, New York, enrolled the first patient.
“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 Dr. Margaret McEntegart, director of the complex PCI Program at Columbia University Medical Center/New York-Presbyterian Hospital and co-principal investigator of EMPOWER CAD. “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.”
