Shockwave’s IVL Included as a Treatment Option in SCAI’s Updated Guideline on PCI With No Surgery on Site Backup

January 31, 2023—Shockwave Medical, Inc., a developer of intravascular lithotripsy (IVL) to treat severely calcified cardiovascular disease, announced that coronary IVL was included in a percutaneous coronary intervention (PCI) guidance document published by the Society of Cardiovascular Angiography & Interventions (SCAI) as a potential therapeutic option in all United States catheterization labs, including facilities without on-site surgical backup.

On January 30, SCAI announced that the guidance, “SCAI Expert Consensus Statement on PCI Without On-Site Surgical Backup,” was published by Cindy L. Grines, MD, et al in the JSCAI.

The updated guidelines, which were previously updated in 2014, will now endorse expanded treatment options and access for patients with calcified coronary lesions.

Shockwave Medical noted that the 2014 guidelines recommended avoiding treatment of high-risk lesions defined as “more than moderate calcification” in facilities without surgical backup. The updated guidelines note the old recommendation “restricted practice, limited patient choice and exposed interventional cardiologists to legal risk.”

The company noted that Clay Sizemore, MD, an interventional cardiologist at Cardiovascular Consultants of South Georgia in Thomasville, Georgia, has been using coronary IVL in his catheterization lab without surgical backup since the technology was FDA approved in 2021, despite the previous guidance.

Dr. Sizemore commented in Shockwave Medical’s press release, “When a lesion is more heavily calcified than is readily apparent on angiography, it is critical to have a strategy to safely and immediately modify the calcium to be able to successfully proceed with the case. The previous guidelines required these patients in facilities without surgical backup be transferred interprocedurally via an ambulance to a cath lab with onsite surgical backup. Not only were these transfers suboptimal for the patient, but they consumed resources in two hospitals as well as valuable physician time that was taken away from treating additional patients.”

Dr. Sizemore continued, “Now, with IVL we have a tool that can safely modify severely calcified lesions, but that does not have the associated risk that requires onsite surgical backup. IVL has allowed us to streamline patient care while providing the best possible outcomes for these patients—it is a win for physicians, the system and for the patients.”