Shockwave Medical has 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% more pulses per catheter than Shockwave C2 and is optimally designed to treat longer calcified lesions and more challenging eccentric and nodular calcium, the company said in a 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 optimise the treatment of the most challenging morphologies,” said Jonathan Hill (Royal Brompton Hospital, London, UK). “The extra pulses are most advantageous in areas with the highest burden of calcium, including nodular, eccentric, diffuse and multivessel calcium.”
Alongside the commercial launch of the C2+ catheter, Shockwave Medical has also announced enrolment of the first patient in EMPOWER CAD, the first prospective, all-female study of percutaneous coronary intervention (PCI), seeking to confirm the benefits of coronary IVL in female patients with calcified lesions, who historically have experienced less favourable clinical outcomes than male patients with traditional therapies.
The first patient was enrolled by Richard A Shlofmitz at St Francis Hospital in Roslyn, USA.
“We are excited to initiate enrolment of the EMPOWER CAD study, the first prospective clinical study in the interventional space that is completely dedicated to female patients,” said Margaret McEntegart (Columbia University Medical Center/New York-Presbyterian Hospital, New York, USA), co-principal investigator of EMPOWER CAD, after she attended the first case performed by 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 McEntegart and Alexandra Lansky (Yale University School of Medicine, New Haven, USA). The study’s European lead is Nieves Gonzalo (Hospital Clinico San Carlos, Madrid, Spain).
Shockwave C2+ is commercially available for the treatment of de novo coronary artery disease in Europe and select other geographies.
