Charles Sternberg, Associate Editor04.05.22
Shockwave Medical recently surpassed two milestones, broadening the opportunity for physicians to use the company’s Intravascular Lithotripsy (IVL) system for the treatment of severely calcified lesions.
“Coronary IVL has clearly demonstrated the ability to safely and effectively treat severely calcified coronary lesions in a Japanese population,” said Shigeru Saito, MD, FACC, FSCAI, FJCC, director of the Department of Cardiology and Catheterization Laboratory at the Shonan Kamakura General Hospital in Kamakura, Japan and principal investigator of Disrupt CAD IV, one of the studies used to support approval for Shockwave C2 in Japan. “Given the safety profile shown to date across multiple studies and calcium morphologies, along with its ease-of-use, I am confident that coronary IVL will offer Japanese physicians a truly unique treatment option for our most challenging patients with calcified lesions.”
The approval of Shockwave C2 was supported by noteworthy 30-day results from the Disrupt CAD IV study, a prospective, multicenter study to assess the safety and effectiveness of IVL in 64 Japanese patients that was published last year in Circulation Journal.i The study met the primary safety endpoint (freedom from major adverse cardiac events, or MACE, at 30 days) and effectiveness endpoint (procedural success, defined as residual stenosis <50% by QCA without in-hospital MACE) with rates of 93.8 percent, which were consistent with results from the Disrupt CAD III study.
From a safety perspective, there were no perforations, abrupt closures, or slow/no-reflow events at any time during the procedures. With all patients receiving intravascular imaging, final stent outcomes showed excellent minimum stent area (5.7 mm2) and stent expansion at the site of maximum calcification (99.5 percent).
“We are delighted to be partnering with the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT) to make this therapy available to the expert cardiologists in Japan,” said Doug Godshall, CEO of Shockwave Medical. “With Japan’s worldwide leadership in the adoption of intravascular imaging and systematic approach to optimizing lesion preparation, we are confident that CVIT will be the perfect partner to help ensure that coronary IVL will play a vital role in the future calcium treatment algorithms of Japanese physicians.”
With the Japan Pharmaceuticals and Medical Devices Agency (PMDA) classifying the Shockwave C2 Coronary IVL Catheter as a new medical device, Shockwave will now await reimbursement approval from the Japanese Ministry of Health, Labour and Welfare (MHLW).
The Shockwave C2 Coronary IVL Catheter previously received CE Mark in 2018 and PMA Approval from the U.S. Food and Drug Administration (FDA) in 2021.
The Shockwave M5+ catheter, which has been in limited launch until now, is specifically designed to decrease IVL treatment time, provide alternative access options, and expand IVL therapy to patients with larger vessel sizes.
“Shockwave’s new peripheral catheter offers remarkable improvements that enable efficient and effective treatment for some of our most difficult-to-treat patients, some of whom previously could not have been treated with IVL,” said Peter Soukas, M.D., of Miriam and Rhode Island Hospitals in Providence, Rhode Island, and one of the first physicians to use the new catheter. “While treating patients with long, severely calcified lesions will always be challenging, the new Shockwave catheter is appropriately sized for larger vessels and has been optimized to expand options for facilitating vessel access, all while decreasing the amount of time needed to perform IVL in the procedure.”
Shockwave M5+ incorporates valued customer feedback to improve IVL efficiency in tackling complex calcified lesions, including quicker cycle time that delivers two pulses per second, an increased catheter length of 135 centimeters, and a new, larger 8.0 millimeter size. The catheter is specifically designed to treat otherwise difficult-to-treat calcified lesions in the peripheral arterial system of the lower extremities, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries.
“The launch of Shockwave M5+ is the latest step in our commitment to expanding the applicability of our technology for more diverse patient populations and anatomies,” said Godshall. “After a very successful limited launch, we are enthusiastic about the global rollout of Shockwave M5+ and the ability to provide our customers with a new tool to advance treatment options – with the consistent reliability and simplicity of IVL that physicians have come to expect when treating patients with Shockwave IVL.”
Shockwave M5+ is now commercially available in Europe and the United States.
Reference:
i https://doi.org/10.1253/circj.CJ-20-1174
Japanese Regulatory Approval of Coronary IVL
On March 30, the Shockwave C2 Coronary IVL Catheter received regulatory approval in Japan.“Coronary IVL has clearly demonstrated the ability to safely and effectively treat severely calcified coronary lesions in a Japanese population,” said Shigeru Saito, MD, FACC, FSCAI, FJCC, director of the Department of Cardiology and Catheterization Laboratory at the Shonan Kamakura General Hospital in Kamakura, Japan and principal investigator of Disrupt CAD IV, one of the studies used to support approval for Shockwave C2 in Japan. “Given the safety profile shown to date across multiple studies and calcium morphologies, along with its ease-of-use, I am confident that coronary IVL will offer Japanese physicians a truly unique treatment option for our most challenging patients with calcified lesions.”
The approval of Shockwave C2 was supported by noteworthy 30-day results from the Disrupt CAD IV study, a prospective, multicenter study to assess the safety and effectiveness of IVL in 64 Japanese patients that was published last year in Circulation Journal.i The study met the primary safety endpoint (freedom from major adverse cardiac events, or MACE, at 30 days) and effectiveness endpoint (procedural success, defined as residual stenosis <50% by QCA without in-hospital MACE) with rates of 93.8 percent, which were consistent with results from the Disrupt CAD III study.
From a safety perspective, there were no perforations, abrupt closures, or slow/no-reflow events at any time during the procedures. With all patients receiving intravascular imaging, final stent outcomes showed excellent minimum stent area (5.7 mm2) and stent expansion at the site of maximum calcification (99.5 percent).
“We are delighted to be partnering with the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT) to make this therapy available to the expert cardiologists in Japan,” said Doug Godshall, CEO of Shockwave Medical. “With Japan’s worldwide leadership in the adoption of intravascular imaging and systematic approach to optimizing lesion preparation, we are confident that CVIT will be the perfect partner to help ensure that coronary IVL will play a vital role in the future calcium treatment algorithms of Japanese physicians.”
With the Japan Pharmaceuticals and Medical Devices Agency (PMDA) classifying the Shockwave C2 Coronary IVL Catheter as a new medical device, Shockwave will now await reimbursement approval from the Japanese Ministry of Health, Labour and Welfare (MHLW).
The Shockwave C2 Coronary IVL Catheter previously received CE Mark in 2018 and PMA Approval from the U.S. Food and Drug Administration (FDA) in 2021.
Global Launch of New Peripheral Intravascular Lithotripsy Catheter
On March 31, Shockwave Medical announced the global commercial availability of the Shockwave M5+ peripheral IVL catheter after receiving both CE Mark and U.S. Food and Drug Administration (FDA) clearance.The Shockwave M5+ catheter, which has been in limited launch until now, is specifically designed to decrease IVL treatment time, provide alternative access options, and expand IVL therapy to patients with larger vessel sizes.
“Shockwave’s new peripheral catheter offers remarkable improvements that enable efficient and effective treatment for some of our most difficult-to-treat patients, some of whom previously could not have been treated with IVL,” said Peter Soukas, M.D., of Miriam and Rhode Island Hospitals in Providence, Rhode Island, and one of the first physicians to use the new catheter. “While treating patients with long, severely calcified lesions will always be challenging, the new Shockwave catheter is appropriately sized for larger vessels and has been optimized to expand options for facilitating vessel access, all while decreasing the amount of time needed to perform IVL in the procedure.”
Shockwave M5+ incorporates valued customer feedback to improve IVL efficiency in tackling complex calcified lesions, including quicker cycle time that delivers two pulses per second, an increased catheter length of 135 centimeters, and a new, larger 8.0 millimeter size. The catheter is specifically designed to treat otherwise difficult-to-treat calcified lesions in the peripheral arterial system of the lower extremities, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries.
“The launch of Shockwave M5+ is the latest step in our commitment to expanding the applicability of our technology for more diverse patient populations and anatomies,” said Godshall. “After a very successful limited launch, we are enthusiastic about the global rollout of Shockwave M5+ and the ability to provide our customers with a new tool to advance treatment options – with the consistent reliability and simplicity of IVL that physicians have come to expect when treating patients with Shockwave IVL.”
Shockwave M5+ is now commercially available in Europe and the United States.
Reference:
i https://doi.org/10.1253/circj.CJ-20-1174