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 ablation portfolio that best supports physicians looking to tackle even the toughest cases. The introduction of the sensor enabled ablation catheter is delivering on that need. It offers the ability to engage the magnetic platform for enhanced precision, especially when physicians encounter a complex case,” Abbott electrophysiology biz medical director Dr. Srijoy Mahapatra said in a press release.

Late last month, Abbott denied reports that it’s pulling its high-end coronary stents from India’s market, after the government there put price caps in place for a variety of medical devices and drugs, including stents.

India’s National Pharmaceutical Pricing Authority last week issued an order capping the price of stents at about $108 (Rs 7,260) for bare-metal devices and $442 (Rs 29,600) for drug-eluting and bioresorbable stents like Abbott’s Absorb, which sells for $2,835 (Rs 190,000) in India.

That prompted Indian media reports that Abbott would pull its high-end drug-eluting stents and the Absorb device, which hit the Indian market in 2012 and is the only resorbable stent available there.

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