This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter
PMA Applicant: Shockwave Medical, Inc.
Address: 5403 Betsy Ross Dr., Santa Clara, CA 95054
Approval Date: February 12, 2021
Approval Letter: Approval letter
What is it?
The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter consists of the Shockwave C2 Coronary IVL Catheter, IVL Connector Cable, and IVL Generator. The catheter is a tube-like device called a balloon catheter that contains integrated lithotripsy emitters, which can break up hard materials (calcification) that restricts blood flow to the heart.
How does it work?
The doctor delivers the catheter to the heart by making a small cut (incision) in the patient’s arm or leg. The lithotripsy emitters at the end of the catheter create pressure waves that are intended to break up the calcification that is restricting the blood flow in the vessels of the heart. This helps open the blood vessels when the balloon is inflated (angioplasty). After using the Shockwave system, the doctor will implant a different device called a stent, which is a metal tube that helps to keep the vessel open.
When is it used?
The Shockwave C2 Coronary IVL Catheter is used before implanting a stent, to open the arteries that supply blood to the heart (coronary arteries) that are narrowed or blocked due to calcification.
What will it accomplish?
The device allows for the opening of calcified arteries to allow stent implantation. In the clinical trial of 384 patients, 92% of them were able to receive the stent and survived without a heart attack or another procedure for 30 days. After one year, approximately 75% of patients had survived without a heart attack or additional procedure.
When should it not be used?
The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2 Coronary IVL Catheter should not be used:
- to deliver a stent, or
- in vessels of the neck or brain.