View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
March 31, 2022

Japan approves Shockwave Medical’s C² Coronary IVL Catheter

Shockwave C² coronary IVL catheter received PMA from the US FDA in 2021 as well as the CE Mark in 2018.

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has given approval to Shockwave Medical’s Shockwave C² Coronary Intravascular Lithotripsy (IVL) Catheter.

Free Report
img

Medical Device Industry Landscape In Asia-Pacific

GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
by GlobalData
Enter your details here to receive your free Report.

The regulatory approval was supported by 30-day results obtained from the prospective, multicentre Disrupt CAD IV study.

In the study, the Shockwave C² Coronary IVL Catheter’s safety and effectiveness were evaluated in 64 Japanese patients.

Shockwave Medical noted that the device met the primary safety endpoint – freedom from major adverse cardiac events (MACE) at 30 days. It also met the effectiveness endpoint with a rate of 93.8%.

The findings from the study were consistent with the data obtained from the Disrupt CAD III trial.

In terms of the safety aspect of the device, there were no abrupt closures, perforations or slow/no-reflow events noted at any time during the procedures.

All participants of the Disrupt CAD IV study received intravascular imaging, which revealed final stent outcomes of a minimum stent area of 5.7mm² and stent expansion at the maximum calcification site of 99.5%.

Shockwave Medical CEO Doug Godshall said: “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.

“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.”

Last year, the Shockwave C² coronary IVL catheter received premarket approval (PMA) from the US Food and Drug Administration (FDA). It also received CE Mark in 2018.

Currently, the company is awaiting reimbursement approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for the device.

Related Companies

Free Report
img

Medical Device Industry Landscape In Asia-Pacific

GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
by GlobalData
Enter your details here to receive your free Report.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. The top stories of the day delivered to you every weekday. A weekly roundup of the latest news and analysis, sent every Friday. The medical device industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Medical Device Network