Abbott wins FDA nod for FlexAbility sensor-enabled ablation cath

Abbott (NYSE:ABT) said today it won FDA approval for its sensor-enabled FlexAbility ablation catheter designed for cardiac ablation procedures to treat atrial flutter. The sensor-enabled FlexAbility ablation catheter is the Abbott Park, Ill.-based company’s 1st designed to collect electrical current resistance and magnetic data to produce accurate mapping and assist in treating sites that trigger or sustain abnormal heart rhythms. “I am seeing an increasing number of patients with complex cardiac arrhythmias, which has created a strong need for advanced tools that can meet the needs of those patients. Sensor Enabled catheters, along with EnSite Precision cardiac mapping system, allow me to quickly identify and treat the arrhythmia, giving me the flexibility and accuracy I need to reach the most challenging locations in the heart to support effective outcomes and improve the lives of my patients,” Dr. Jeffrey Winterfield of the Medical University of South Carolina said in a prepared statement. The device is also compatible for use with the EnSite Precision cardiac mapping system, the company said, which allows for the creation of highly detailed 3D cardiac models with the heart’s electrical activity overlaid on it. The catheter is also compatible with Abbott’s MediGuide technology, designed to reduce the duration of live X-ray during procedures. “We are continuing to innovate around the EnSite Precision cardiac mapping system to create an ab...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiovascular Catheters Food & Drug Administration (FDA) Regulatory/Compliance Abbott Source Type: news