News | Cath Lab | September 03, 2019

FDA Grants Shockwave Medical Breakthrough Status for Coronary Intravascular Lithotripsy

Agency’s Breakthrough Device Designation program allows for priority review of coronary calcium modification technology

FDA Grants Shockwave Medical Breakthrough Status for Coronary Intravascular Lithotripsy

September 3, 2019 — Shockwave Medical Inc. has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Shockwave intravascular lithotripsy (IVL) system with the Shockwave C2 Coronary IVL Catheter. The device is currently the subject of an Investigational Device Exemption (IDE) study called DISRUPT CAD III. The Shockwave C2 IVL Catheter is a proprietary tool designed to fracture problematic calcium using sonic pressure waves in order to facilitate stent delivery, deployment and optimal expansion, thereby improving blood flow to the heart muscle.

The FDA Breakthrough Device Program is intended to help patients and healthcare providers receive more timely access to medical devices that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA will provide Shockwave Medical with priority review and interactive communication during the Shockwave C2 IVL Catheter premarket review phase.

Coronary artery calcium physically impairs blood flow and restricts artery dilation, which inhibits stent expansion1 and is perhaps the single most important predictor of restenosis and early stent thrombosis,2 or coronary artery re-narrowing and blood clots, within the stent after-stent procedures.

DISRUPT CAD III is a prospective, non-randomized, multicenter global IDE study to demonstrate the safety and effectiveness of the Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter in de novo, calcified, stenotic, coronary arteries prior to stenting. The study is approved to enroll 442 patients at 50 centers in the United States and Europe, and is led by co-principal investigators Dean Kereiakes, M.D., and Jonathan Hill, M.D. As reported in the company’s second quarter earnings call, the study had enrolled 108 patients as of June 30, 2019.

Shockwave C2 Coronary IVL catheters are commercially available for the treatment of de novo coronary artery disease in Europe and select other geographies; they are limited to investigational use in the United States.

For more information: www.shockwavemedical.com

Related Content

VIDEO: Breaking Up Calcified Lesions Without Vessel Trauma

Intravascular Lithotripsy: Will This New Investigational Technology Crack Calcium’s Code in the U.S.?

FDA Clears Lithoplasty Balloon That Shatters Calcified Lesions With Ultrasound

References

1. Chambers J.W., Feldman R.L., Himmelstein S.I., et al.Pivotal trial to evaluate the safety and efficacy of the orbital atherectomy system in treating de novo, severely calcified coronary lesions (ORBIT II). Journal of the American College of Cardiology: Cardiovascular Interventions, May 2014. doi: 10.1016/j.jcin.2014.01.158.

2. Généreux P., Madhavan M.V., Mintz G.S., et al. Ischemic outcomes after coronary intervention of calcified vessels in acute coronary syndromes. Pooled analysis from the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) and ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) TRIALS. Journal of the American College of Cardiology, May 2014. doi: 10.1016/j.jacc.2014.01.034. Epub 2014 Feb 19.

Related Content

A large subgroup analysis of the VOYAGER PAD randomized clinical trial showed neither a mortality risk nor benefit associated with the use of paclitaxel drug-coated devices (DCD) in the treatment of peripheral artery disease (PAD). The study also found that the benefit of rivaroxaban use on reducing ischemic limb and cardiovascular outcomes was consistent regardless of whether a DCD was used. #TCT2020 #TCTconnect
Feature | Cath Lab | October 18, 2020
October 18, 2020 – A large subgroup analysis of a randomized clinical trial showed neither a mortality risk nor benef
A longitudinal vessel assessment may demonstrate co-existence of multiple plaque morphologies on OCT, including superficial calcification with thrombus, healed plaque, plaque rupture, lipidic plaque with a thin capped fibrous atheroma (TCFA). #TCTconnect #TCT2020

A longitudinal vessel assessment may demonstrate co-existence of multiple plaque morphologies on OCT, including superficial calcification with thrombus, healed plaque, plaque rupture, lipidic plaque with a thin cap fibro-atheroma (TCFA).

News | Cath Lab | October 18, 2020
October 18, 2020 – Data from the...
The DISRUPT CAD III study showed intravascular lithoplasty from Shockwave Medical was effective in breaking up calcified coronary lesions. #TCT2-0

The DISRUPT CAD III study showed intravascular lithoplasty from Shockwave Medical was effective in breaking up calcified coronary lesions.

Feature | Cath Lab | October 16, 2020
October 15, 2020 — Shockwave Medical's Intravascular Lithotripsy (IVL) system to treat severely calcified coronary ar
Videos | Cath Lab | October 16, 2020
This is an example pf the Shockwave Medical Intravascular Lithotripsy (IVL) catheter system designed to break up heav
Videos | Cath Lab | July 15, 2020
Richard Botto, CVT, RCSA, chief cardiovascular technologist, division of cardiology, cardiac cath lab, offers an over
Videos | Cath Lab | July 13, 2020
The Vieussens’ arterial ring (VAR) is a connection between the conus artery and the left anterior descending (LAD) co
News | Cath Lab | July 06, 2020
July 6, 2020 — Black patients who undergo percutaneous coronary intervention (PCI) are at an increased risk for major
TCT cancels in-person meeting and goes virtual due to COVID-19
News | Cath Lab | May 27, 2020
May 27, 2020 — To ensure the health and safety of all attendees due to the ongoing COVID-19 (SARS-CoV-2) pandemic, th