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FDA approves next-generation balloon for AF treatment
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CardioFocus, announced the approved its next-generation balloon designed for the treatment of paroxysmal AF.
The balloon (HeartLight Excalibur Balloon) is expected to be fully launched in the United States in late 2018, according to a press release from the company. It was launched in Europe in September.
The balloon incorporates proprietary dynamic response technology which allows real-time adjustments to balloon size, allowing for optimal tissue contact, according to the release.
This feature combined with an ultra-compliant design may maximize the engagement of the balloon with the pulmonary veins, while decreasing the time required to complete ablation procedures, the company stated in the release.
"We have seen encouraging results with the Excalibur Balloon. It obtains an impressive antral position and establishes even more tissue contact, which enables contiguous lesion sets," Vivek Y. Reddy, MD, director of cardiac electrophysiology and Helmsley Trust Professor of Medicine at the Icahn School of Medicine at Mount Sinai, said in the release. "This is a clear advance in the field of balloon-based AF ablation, delivering on the promise of an ultra-compliant balloon."
Disclosures: Reddy reports he has financial ties with Abiomed, ACT, Acutus Medical, Apama Medical, Biosense Webster, Biotronik, BioSig Technologies, Boston Scientific, CardioFocus, CardioInsight Technologies, Cardionomics, Cibiem, Circa Scientific, Coherex Medical, DC Devices, EBR, Estech, GBS, Impulse Dynamics, Javelin, Keystone Heart, Magnetecs, Manual Surgical Sciences, Medtronic, Middle Peak Medical, NewPace Technology Development, Perseus PCI, St. Jude Medical and VytronUS.