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Updated SCAI Guidance Includes Coronary IVL as a Treatment Option in All U.S. Catheterization Labs Regardless of Surgical Backup Status
Guidance Expands Number of Hospitals that Can Access IVL to Include Sites Where Calcium Modification Tools Were Previously Not Recommended
Guidance Expands Number of Hospitals that Can Access IVL to Include Sites Where Calcium Modification Tools Were Previously Not Recommended
SANTA CLARA, Calif., Jan. 31, 2023 -- Shockwave Medical, Inc., a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, today announced that coronary IVL was included in a treatment guidance document published by the Society of Cardiovascular Angiography and Intervention (SCAI) as a potential therapeutic option in all U.S. catheterization labs. - including facilities without on-site surgical backup. The latest guidance – SCAI Expert Consensus Statement on PCI Without On-Site Surgical Backup – was published online in the Journal of the Society of Cardiovascular Angiography and Intervention (JSCAI).
The updated guidelines, which modify the previous 2014 guidelines by no longer restricting recommended treatment to facilities with on-site surgical backup, will now endorse expanded treatment options and access for patients with calcified coronary lesions.
“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,” said Dr. Clay Sizemore, Interventional Cardiologist at Cardiovascular Consultants of South Georgia in Thomasville, Ga., who has been using coronary IVL in his catheterization lab without surgical backup since the technology was FDA approved in 2021, despite the previous guidance. “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 sub-optimal for the patient, but they consumed resources in two hospitals as well as valuable physician time that was taken away from treating additional patients.”
“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,” continued Dr. Sizemore.
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.”
“With the interventional field rapidly evolving, we commend SCAI for continuously evaluating current interventional practices to ensure that their consensus documents accurately provide the best possible guidance for optimal patient care,” said Doug Godshall, Chief Executive Officer of Shockwave Medical. “We look forward to working with sites that have not yet adopted coronary IVL due to their lack of surgical backup and to expanding the number of centers that have access to our technology due to this new guidance.”
About Shockwave Medical, Inc.
Shockwave is focused on developing and commercializing products intended to transform the way calcified cardiovascular disease is treated. Shockwave aims to establish a new standard of care for the interventional treatment of atherosclerotic cardiovascular disease through differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque, which the company refers to as Intravascular Lithotripsy (IVL). IVL is a minimally invasive, easy-to-use and safe way to significantly improve patient outcomes. To view an animation of the IVL procedure and for more information, visit www.shockwavemedical.com.
