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™ Cardiac Ablation System
Applicant: Irvine Biomedical, Inc.
Address: 2375 Morse Ave., Irvine, CA 92614
Approval Date: January 14, 2005
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf4/P040014a.pdf
What is it? The IBI Therapy™ System is a cardiac ablation system used to treat certain kinds of abnormal heart rhythms (arrhythmia) by finding the source of the rhythm disturbances and destroying (ablating) small areas of heart tissue. The system has an ablation catheter and an energy generator. The catheter is a long, thin, flexible tube that takes energy from the generator to a point inside the heart.
How does it work? The ablation catheter is put into a blood vessel through a small cut in the skin. The ablation catheter is threaded through the blood vessel and into the heart. The tip of the catheter is placed against the spot in the heart that is causing the abnormal rhythm and electrical recordings are made to see that the catheter is in the right place. The catheter is connected to the energy generator and energy is delivered to the target spot. The energy destroys small areas of heart tissue that are causing the abnormal heart rhythm.
When is it used? The IBI Therapy™ Catheter is used to destroy small areas of heart tissue that cause an abnormally fast heart beat in the upper chambers (the atria) of the heart. The technical name for this kind of abnormal heart beat is “SVT” (supraventricular tachycardia).
What will it accomplish? Cardiac ablation can cure some rhythm disturbances, and in other cases can reduce the frequency of episodes that the patient experiences. The IBI Therapy™ Ablation System can be used both to find the source of the rhythm disturbances and then, in combination with the energy generator, to deliver therapy to treat the problem.
When should it not be used? The IBI Therapy™ Ablation System should not be used:
- In patients with active systemic infection;
- Via the retrograde transaortic approach in patients with aortic valve replacement, or;
- Via the transseptal approach in patients with left atrial thrombus or myxoma, or interatrial baffle or patch.
Summary of Safety and Effectiveness and labeling will be available at: