Technology | Ablation Systems | March 11, 2016

Boston Scientific Receives FDA Approval for Blazer Open-Irrigated Catheter

FDA approval granted on the heels of CE Mark for the IntellaTip MiFi open-irrigated catheter

March 11, 2016 — Boston Scientific has received U.S. Food and Drug Administration (FDA) approval for the Blazer Open-Irrigated (OI) radiofrequency ablation catheter. The Blazer OI catheter has been approved to treat Type I atrial flutter, an abnormal rhythm of the upper chambers of the heart. The approval of the Blazer OI catheter marks the first time Boston Scientific will offer an open-irrigated catheter to the U.S. market.

The device is designed for use in ablation procedures to restore a normal heart rhythm for patients in atrial flutter. During the procedure, localized electrical energy is delivered through an electrode on the tip of a catheter into the heart muscle, creating heat to destroy a small area of the tissue responsible for the abnormal heart rhythm. The catheter features Total Tip Cooling technology intended to cool the catheter tip consistently during the ablation procedure, improving the quality of the ablation lesion.

The Blazer OI catheter was granted approval based on data from the BLOCk-CTI clinical trial, a prospective, randomized trial that enrolled 302 patients at 24 sites in the United States. It evaluated the safety and effectiveness of the Blazer OI catheter in patients with sustained or recurrent Type 1 atrial flutter.

"Successful results from the BLOCk-CTI trial demonstrate that the Blazer open-irrigated catheter is safe and effective for the ablation of atrial flutter," said Tom McElderry, M.D., principal investigator, associate professor and section chief of electrophysiology at the University of Alabama at Birmingham. "This newly approved ablation tool was built on the proven Blazer platform of therapeutic catheters and facilitates excellent maneuverability, consistent cooling and stability during procedures."

In January, the company also received CE Mark for the IntellaTip MiFi OI catheter for use in all cardiac ablation procedures. The IntellaTip MiFi OI catheter is designed to provide physicians precise, multidimensional information via mini-electrodes which deliver a highly localized signal reflecting exactly what is happening at the tip of the catheter in real-time during the ablation procedure. The IntellaTip MiFi OI catheter also features Total Tip Cooling technology.

In the U.S., the IntellaTip Mifi OI catheter is an investigational device and is not available for sale.

For more information:

Related Content

Noninvasive Radioablation Offers Long-term Benefits to High-risk Heart Arrhythmia Patients
News | Ablation Systems | September 17, 2019
September 17, 2019 — Treating high-risk heart patients with a single, high dose of radiation therapy can dramatically
Biosense Webster Announces Initial Results From First-in-Human QDOT-FAST Study
News | Ablation Systems | May 16, 2019
Johnson & Johnson Medical Devices Companies announced that Biosense Webster, Inc.’s QDot Micro catheter...
CardioFocus Announces Results From HeartLight X3 Ablation System Pivotal Study
News | Ablation Systems | May 16, 2019
CardioFocus Inc. announced the presentation of results from its pivotal confirmatory study evaluating the HeartLight X3...
New Global Consensus Statement Addresses Catheter Ablation of Ventricular Arrhythmias
News | Ablation Systems | May 14, 2019
The Heart Rhythm Society (HRS) in partnership with three other professional societies issued an international consensus...
Netherlands Hospital to Install State-of-the-Art MRI Ablation Center
News | Ablation Systems | May 13, 2019
Imricor announced the signing of a commercial agreement with the Haga Hospital in The Hague, Netherlands to outfit a...
A CyberHeart cardiac ablation radiotherapy treatment plan showing where the radiation beam will ablate for a noninvasive pulmonary vein isolation procedure. Varian acquires, buys, purchases Cyberheart.

A CyberHeart cardiac ablation radiotherapy treatment plan showing where the radiation beams will ablate for a noninvasive pulmonary vein isolation procedure to treat an arrhythmia.

Feature | Ablation Systems | May 10, 2019 | Dave Fornell, Editor
May 10, 2019 — Radiation oncology vendor Varian announced it acquired the start-up company CyberHeart, which has deve
Ablation Reduces Risk of Dementia in Patients With AFib and Carotid Artery Disease
News | Ablation Systems | May 08, 2019
Even though many medical practitioners may opt not to perform procedures on higher-risk patients, new research finds it...
CardioFocus Announces European CE Mark Approval Of HeartLight X3 System
News | Ablation Systems | April 16, 2019
CardioFocus Inc. announced the European CE Mark approval of the HeartLight X3 Endoscopic Ablation System.
First Patient Treated With QDot Micro Ablation Catheter
News | Ablation Systems | February 04, 2019
Biosense Webster has enrolled and treated the first patient in its U.S. Investigational Device Exemption (IDE) study...
Overlay Init