St. Joseph’s Hospital Heart and Vascular Institute of Tampa has become the first healthcare provider in Central Florida to utilize a balloon catheter designed by Boston Scientific to perform cardiac cryoablation to treat paroxysmal atrial fibrillation (AFib).

In August, the FDA approved the POLARx Cryoablation System, which includes the POLARx Fit Cryoablation Balloon catheter, a device that expands the balloon to two sizes — 28 mm and 31 mm. Through this capability, the solution can occlude diverse pulmonary vein anatomies and also makes more complete contact with tissues to better apply treatment to areas of the heart where disruptive signals that cause AFib originate.

"By prioritizing procedural flexibility and individualized care, this offering transforms a key therapy in the electrophysiology space," said Nick Spadea-Anello, president of electrophysiology at Boston Scientific, in a statement.
St. Joseph's Hospital, which serves the Tampa Bay and Greater Orlando areas, has been participating in clinical trials for POLARx since 2020 and used the technology for the first time in a real-world clinical setting last month. With the technology, it can now offer patients in these areas another cryoablation option that can reduce their risk of blood clots, stroke, and heart failure, which can result from AFib.

The hospital is the third in the state of Florida to utilize the system following its approval. Delray Medical Center performed the first exam on September 11.

“This is one more arrow in our quiver to treat complex cardiac conditions, and we expect future technologies to build on this advancement,” said Delray Medical Center CEO Daniel Listi in a statement at the time.

In the FROZEN-AF IDE clinical trial, a global, prospective, non-randomized, single-arm study, the system and catheter were used on 385 patients with paroxysmal AFib. At 12 months post-treatment, freedom from procedure- or device-related events, was 96%, and there were no reports of moderate or severe pulmonary vein stenosis, persistent phrenic nerve palsy, or esophageal fistulas. The rate of freedom from documented atrial arrhythmias was 79.9%.

St. Joseph’s Hospital is one of 16 hospitals under the BayCare Health System, which opened its most recent one earlier this year in Wesley Chapel to provide emergency services to Pasco County residents and neighboring Hernando Counties. It paid $246 million to design and construct the 86-bed, 318,000-square-foot facility, which offers diagnostic imaging and lab services and performs surgical procedures, including robotic surgery, urology, and wound care.

The POLARx Cryoablation System has been used on more than 25,000 patients worldwide, has the CE mark, and is also approved for use in Japan. The catheter is approved in Europe, Japan, Canada, and other Asia Pacific markets.

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