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: Helios II Ablation Catheter
PMA Applicant: Stereotaxis Inc.
Address: 4320 Forest Park Blvd, Suite 100, St. Louis, MO 63108 USA
Approval Date: October 10, 2008
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf5/p050029a.pdf
What is it?The Helios II Ablation Catheter is a magnetically guided catheter that is 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 catheter is a long, thin, flexible tube, about the thickness of a piece of spaghetti. It takes energy from an external energy source (a generator) to a point inside the heart.
How does it work? The Helios II Ablation Catheter is inserted into a blood vessel (artery or vein), usually through a site in the upper leg or neck. The tube is advanced through the blood vessels until it reaches the heart either manually or by a catheter advancement system. The catheter has small magnets attached to the tip. The tip is moved around by a large magnet (called the magnetic navigation system) that is located in the same room as the patient. As the direction of the permanent magnet is shifted, this causes the catheter tip to also move.
In the heart, electrodes at the catheter tip gather data that pinpoint the location of faulty tissue in the heart (electrical mapping). Once the site is identified, the device delivers radiofrequency energy (RF ablation) to destroy the small section of tissue.
When is it used? The Helios II Ablation Catheter is used to destroy small areas in the heart 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), or more specifically, “AVNRT” (atrioventricular node re-entry tachycardia), “AVRT” (atrioventricular re-entrant tachycardia) and , when desired, the creation of complete heart block for the treatment atrial fibrillation with a rapid ventricular response that is difficult to control with medicine.
What will it accomplish? Cardiac catheter ablation can cure some rhythm disturbances and restore a normal heart rhythm, and in other cases, can reduce the frequency of episodes that a patient experiences. When used with an energy generator, the Helios II Catheter can be used to find the source of the rhythm disturbances and then delivery therapy to treat the problem.
When should it not be used? The Helios II catheter should not be used:
- in the coronary vasculature, other than the coronary sinus;
- in patients with active systemic infection;
- via the transseptal approach in patients with left atrial thrombosis or myxoma, or interatrial baffle or patch; or
- via the retrograde transaortic approach in patients with aortic valve replacement.
Additional information: The Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p050029