Shockwave Medical (Nasdaq:SWAV) today announced the full commercial availability of C.2+ Coronary intravascular lithotripsy (IVL) catheter.
The company designed C2+ A coronary IVL catheter that uses pulsatile acoustic pressure to treat severe calcifying coronary artery disease. Santa Clara, Calif.-based Shockwave, which has been the subject of recent acquisition speculation, has launched the catheter in select international markets.
Shockwave C2+ Marketed for the Treatment of Denobah Coronary artery disease in Europe and some other regions.
last month, bloomberg Boston Scientific reported that it is considering buying Shockwave. Last week, a Streetinsider.com report said Medtronic and Johnson & Johnson were also interested. The reports were from anonymous sources. Both Medtronic and Shockwave declined to comment on the speculation.
The company said in a news release that C2+ Provides 50% more pulses per catheter than previous C2 version. Its design allows treatment of longer calcified lesions and more difficult eccentric and nodular calcium.
“Shockwave C”2+ It retains the intuitive catheter design and ease of use that are fundamental to the success of the Shockwave IVL, and incorporates improvements that increase the efficiency of the procedure and optimize treatment for the most challenging forms,” said Royal Hospital Consultant. cardiologist Jonathan Hill, M.D. Brompton Hospital in London. “Extrapulse is most advantageous in areas with the highest calcium load, such as nodular, eccentric, diffusive and multivascular calcium.”
Shockwave also shares clinical trial news
The company also announced the enrollment of the first patient in the EMPOWER CAD study. This is the first prospective, all-female study of percutaneous coronary intervention (PCI), Shockwave said.
The 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 conventionally treated male patients. Dr. Richard A. Schrofmitz of St. Francis Hospital in Roslyn, New York enrolled the first patient.
“We are thrilled to begin enrollment for the EMPOWER CAD study, the first prospective clinical study in the interventional space entirely dedicated to female patients,” said Composite PCI Program Director, Columbia University Medical Center/New. said Dr. Margaret Maentegart of She is a co-Principal Investigator at York Presbyterian Hospital and she is an EMPOWER CAD. “This is a major step towards a better understanding of the optimal strategy for calcium modification in female patients, who are underrepresented, more difficult to treat and often experience suboptimal outcomes.” patient population.”