The planned introduction of the Shockwave C2+ coronary IVL catheter follows the receipt of FDA approval. This catheter offers 50% more pulses per catheter than the Shockwave C2 catheter that the FDA approved in June 2021.
Santa Clara, California-based Shockwave Medical plans to introduce the catheter at the 35th Transcatheter Cardiovascular Therapeutics (TCT) annual scientific symposium of the Cardiovascular Research Foundation next week. It expects to roll out a full commercial launch shortly after at the beginning of November.
“The enhancements of Shockwave C2+ will be an added benefit of IVL for optimally treating complex calcium, including more diffuse disease, as well as nodular and thick, eccentric calcium,” said Dr. Richard Shlofmitz, chair of the Dept. of Cardiology, St. Francis Hospital in Roslyn, New York.
Shlofmitz performed the first U.S. commercial case with Shockwave C2+.
“When additional pulses are added to the existing intuitive catheter design and simple-to-use system that are foundational to the success of Shockwave IVL, the result is an updated catheter that can enhance workflow and improve procedural efficiency,” he added.
More about Shockwave and IVL
Shockwave Medical seeks to transform the treatment of calcified cardiovascular disease. Its aims include establishing a new standard of care for the interventional treatment of atherosclerotic cardiovascular disease. Shockwave offers differentiated and proprietary local delivery of sonic pressure waves to treat calcified plaque.
The company designed its minimally invasive, easy-to-use, safe treatment to improve patient outcomes. IVL safely modifies calcium while significantly reducing the risk of complications. It makes procedures more predictable and efficient.
A company with great upside potential, reports from Bloomberg earlier this year suggested potential acquisition interest from Boston Scientific. Later reports the following month linked Medtronic and Johnson & Johnson with interest in buying the company.
In August, the company announced an upsized offering worth $650 million as it looks to advance its IVL platform.