INTELLANAV STABLEPOINT™ Ablation Catheter & Force Sensing System on the RHYTHMIA HDX™ Mapping System - P150005/S074
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: INTELLANAV STABLEPOINT Ablation Catheter & Force Sensing System on the RHYTHMIA HDX Mapping System
PMA Applicant: Boston Scientific Corporation
Address: 4100 Hamline Avenue North, St. Paul, MN 55112, USA
Approval Date: 02/26/2024
Approval Letter: Approval Order
What is it?
The INTELLANAV STABLEPOINT Ablation Catheter uses radiofrequency (RF) energy applied by the catheter tip to destroy heart tissue cells that are causing heart rhythm problems (arrhythmias).
A doctor puts the catheter through a small cut in a vein in the groin and moves the tip of the catheter up to the heart. The doctor places the tip at different locations in the heart and uses the generator to send RF energy. The RF energy heats and scars cells in the heart tissue, which blocks the electrical signals that cause abnormal heart rhythms. The catheter is removed after treatment.
The INTELLANAV STABLEPOINT Ablation Catheter & Force Sensing System on the RHYTHMIA HDX Mapping System can treat adults with drug-resistant, recurrent, symptomatic paroxysmal atrial fibrillation (AF) – repeated episodes of irregular heartbeat within the upper heart chambers. Paroxysmal AF symptoms may include shortened breath, racing heart, chest pain, or dizziness. It also can treat typical atrial flutter (rapid heartbeat in the right atrium) in adults.
The device is used to regulate the heartbeat in people with paroxysmal AF. In a clinical study, doctors safely and effectively used the device with 299 patients with heart arrhythmias including AF, atrial flutter, and atrial tachycardia. Patients were checked after the procedure and at 1 month, 3 months, 6 months, and 12 months later for adverse events and recurrence of arrhythmias.
The INTELLANAV STABLEPOINT Catheter should not be used by people who:
- Have active systemic infection
- Have a mechanical prosthetic heart valve through which the catheter must pass
- Have conditions where insertion into or manipulation in the cardiac chambers is unsafe and may increase the risk of blood vessel blockage (embolism) or heart puncture (cardiac perforation)
- Are unable to receive heparin or an alternative blood thinner
- Have vena cava embolic protection filter devices or blood clot in the leg vein (femoral thrombus) and require catheter insertion in the leg
- Have unstable blood pressure which lessens blood flow to the organs
- Cannot have a procedure where insertion or manipulation of a catheter in the cardiac chambers is deemed unsafe, because of a recent previous cardiac surgery, or congenital heart disease, which makes ablation more risky
- Are receiving an intra-atrial baffle or a foramen ovale patch redirecting blood flow in the heart
- Have a prosthetic aortic valve and are being catheterized through a small artery in the upper leg
Clinicians should not use this device:
- With a long sheath or a short introducer which measures less than size 8.5 French.
- In the coronary arteries.