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: CryoCor Cryoablation System (CryoBlator Catheters & Model 2020 Console)
PMA Applicant: CryoCor, Inc.
Address:9717 Pacific Heights Boulevard , San Diego, California 92121
Approval Date: August 1, 2007
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf5/p050024a.pdf
What is it? An “ablation catheter” is a plastic tube used to destroy (ablate) abnormal tissue or tissue that allows a rapid heart beat to occur. The CryoCor Cryoablation System causes ablation by applying extreme cold at the tip of the catheter, destroying the heart tissue responsible for causing an abnormal heart beat (tachycardia).
How does it work? The plastic tube is put into a vein near the groin at the top of the leg (the femoral vein). The plastic tube is then threaded through the vein into the right atrium of the heart. The plastic tube end outside the body is connected to the electrical system that allows the physician to view signals from the beating heart on a screen. By watching the screen, the doctor can place the plastic tube in exactly the correct spot to treat the abnormal heart beats. Once the plastic tube is in place, the doctor uses the Cryoablation System Console to initiate cooling at the tip of the tube. This cooling destroys a small part of the heart tissue and eliminates the abnormal heart beat.
When is it used? This ablation catheter system is used in patients who have right atrial isthmus-dependent flutter -- a specific kind of fast heart beat (tachycardia) occurring in the right atrium of the heart.
What will it accomplish? The destruction of a small amount of heart tissue (ablation) will block the abnormal electrical pathways in the heart that cause right atrial isthmus-dependent flutter. The procedure has been shown to cure atrial flutter acutely in approximately 88% of patients. Of those cured acutely, approximately 82% remain cured after 6 months.
When should it not be used? The catheter should not be used in patients who have:
- an infection in the blood
- a blood clot inside the heart
- antibody reactions to cold (cryoglobulinemia)
- experienced surgical heart procedures (ventriculotomy or atriotomy) in the preceding 4 weeks.
Additional information: The Summary of Safety and Effectiveness and labeling are available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p050024