SJM’s Latest Cardiac Ablation Catheters Receive FDA Clearance

SJM’s Latest Cardiac Ablation Catheters Receive FDA Clearance

Therapy Cool Path Duo™ Ablation Catheter, Safire BLU Duo™ Ablation Catheter, and IBI1500T9-CP V1.6 Cardiac Ablation Generator – P110016

Photo of 3 Ablation Catheters.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: Therapy Cool Path Duo™ Ablation Catheter, Safire BLU Duo™ Ablation Catheter, and IBI1500T9-CP V1.6 Cardiac Ablation Generator

PMA Applicant: Irvine Biomedical, Inc., A St. Jude Medical Company

Address: 2375 Morse Ave., Irvine, CA 92614

Approval Date: January 25, 2012

Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf11/p110016a.pdf

What is it? The Therapy Cool Path Duo™ Ablation Catheter or the Safire BLU Duo™ Ablation Catheter is a steerable, deflectable, irrigated catheter (a long, thin, flexible tube) used to treat a certain kind of abnormal heart rhythm (arrhythmia) called typical atrial flutter by finding the source of the rhythm disturbance and destroying (ablating) small areas of the heart tissue. The catheters take energy from an external source (the IBI1500T9-CP V1.6 Cardiac Ablation Generator) to a point in the right side of the heart.

How does it work? The Therapy Cool Path Duo™ Ablation Catheter or the Safire BLU Duo™ Ablation Catheter is inserted into a blood vessel (artery or vein), usually though a site in the upper leg or neck. The catheter is manually advanced through the blood vessels until it reaches the correct location inside the heart. The tip of the catheter is moved around by a mechanism on the handle. Inside the heart, electrodes at the tip gather data that pinpoint the location of the faulty tissue in the heart (electrical mapping). Once the site is identified, the device delivers radiofrequency (RF) energy to destroy the small areas of tissue that blocks the heart’s internal electrical signals that cause the typical atrial flutter. The catheters are removed after treatment.

When is it used? The Therapy Cool Path Duo™ Ablation Catheter or the Safire BLU Duo™ Ablation Catheter, and the IBI 1500T9-CP V1.6 Cardiac Ablation Generator are used to destroy small areas in the heart that cause an abnormally fast heart beat or abnormal heart rhythm in the upper chambers (the atria) of the heart. The technical name for this kind of abnormal heart beat is typical atrial flutter.

What will it accomplish? Cardiac catheter ablation can cure typical atrial flutter and restore a normal heart rhythm, and in other cases, can reduce the frequency of episodes that a patient experiences. In a clinical study involving 188 patients, the abnormal rhythm (typical atrial flutter) was corrected in 181 patients (96%) for 7 days after treatment; and it remained corrected after 3 months in 174 patients (94.5%).

When should it not be used? The device should not be used in patients:

who have an active systemic infection.

with a blood clot attached to the inside of the heart.

who have had an incision in the atrium or ventricle in the last 4 weeks.

Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.

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- Features

Externally irrigated ablation catheter with additional irrigation ports for more uniform cooling

Lower average measured tip temperature at equivalent flow rates compared to distal tip irrigation only 1, 3

Fewer incidences of coagulum and charring observed in preliminary study 2

All-braided construction provides uninterrupted torque transfer for more responsive handling

M, L, XL, and L1 curve configurations

1 Bench data on file at IBI

2 Ex vivo pre-clinical data on file at IBI

3 When Cool Path catheters are connected to the Cool Point™ pump, the flow rate should be used within approved labeling (600 to 999 ml/hr)

The FDA has cleared St. Jude Medical to initiate a clinical trial of the company’s Duo irrigated ablation catheter for treatment of atrial fibrillation. The device, which already has the European CE mark, features twelve irrigation ports that should provide better cooling of the electrode during ablation.

Therapy%20Cool%20Path%20Duo%20Irrigated%20Ablation%20Catheter CPDuo spray.ashx Duo Ablation Catheter Going on Trial

The IRASE AF trial is the industry’s first and the largest head-to-head IDE trial studying irrigated ablation catheters, which use radiofrequency (RF) energy in a non-invasive procedure to destroy abnormal heart tissue. The trial will randomize patients 1:1 between the company’s Duo 12 port open irrigated catheter ablation system and an irrigated catheter ablation system that has been approved by the FDA for the treatment of paroxysmal AF, a type of AF that begins suddenly and ends spontaneously. The trial is expected to take about three years to complete and will take place in both the U.S. and international markets with 324 patients.

When the first line of therapy for the treatment of paroxysmal AF using antiarrhythmic medication is ineffective, RF ablation is currently recommended as a second line of therapy for long-term cardiac arrhythmia control. The IRASE AF pivotal study intends to determine whether or not ablation using the company’s Duo 12 port open irrigated catheter system is safe and effective compared to the other market approved catheter for treatment of symptomatic paroxysmal AF. It will also determine if the ablation catheter can be indicated for the treatment of symptomatic paroxysmal AF.

The trial’s primary efficacy endpoints are targeted pulmonary vein isolation (acute) and freedom from symptomatic AF for 12 months (chronic) following the procedure. The primary safety endpoints are freedom from acute major adverse events within seven days of the procedure and chronic major adverse events within 12 months.

Source : http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm290153.htm

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