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 and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: IBI Therapy ™ Dual 8 ™ Ablation Catheter and IBI 1500T6 ( USA ) Generator
Applicant: Irvine Biomedical, Inc.
Address: 2375 Morse Ave. Irvine , CA 92614
Approval Date: November 18, 2005
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf4/P040042a.pdf
What is it? A catheter is a flexible hollow plastic tube about the thickness of a piece of spaghetti that can be placed into a body cavity. An “ablation catheter” is a catheter used to destroy (ablate) abnormal tissue. An ablation catheter for the heart has wires running on the inside of the tube. The wires connect to an electrical system that allows a physician to view the heart’s action on a viewing screen. This ablation catheter is also connected to a generator that delivers energy (radiofrequency – RF waves) to the tip of the catheter in the heart. The RF energy generates heat that destroys abnormal heart tissue responsible for causing an abnormal heart beat (tachycardia).
How does it work? The catheter is put into a vein near the groin at the top of the leg (the femoral vein). The catheter is then threaded through the vein into the chambers of the heart. The catheter end outside the body is connected to the electrical system that allows the physician to view the beating heart on a screen. By watching the screen, the doctor can place the catheter in exactly the correct spot to treat the abnormal heart beats. Once the catheter is in place, the doctor turns on the energy from the generator to heat the tip of the catheter. This heat ablates a small part of the heart that causes the abnormal heart beat.
When is it used? This ablation catheter system is used in patients who have atrial flutter -- a specific kind of fast heart beat (tachycardia) occurring in the heart’s upper chambers (the atria).
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 atrial flutter. The procedure has been shown to cure atrial flutter in approximately 93% of patients.
When should it not be used? The catheter should not be used in patients who have:
- an infection in the blood
- a tumor or blood clot inside the heart
Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p040042