CHICAGO – Atrial fibrillation (AF) impacts about 33 million patients worldwide. Med-tech companies have responded to the challenge AF presents and have developed a number of ablation technologies to treat the disease. On Tuesday, a panel at this year's Heart Rhythm Society's (HRS) Scientific Sessions discussed some of the devices on the forefront of AF Ablation.
Nearly 10 years ago, med-tech companies went on a spending spree to either enter the AF market or secure a stronger foothold in it. These companies include Abbott Laboratories Inc.'s St. Jude Medical, which acquired West Berlin, N.J.-based EP Medsystems Inc. for $92 million and Haifa, Israel-based Mediguide Inc., for more than $300 million. Dublin-based Medtronic plc strengthened its position by picking up Montreal-based Cryocath for about $400 million in 2008.
However, one of Medtronic's most significant acquisitions in the space was Ablation Frontiers. Through the $225 million buy, the company was able to secure the Artic Front technology. (See Medical Device Daily, Feb. 9, 2009.) Medtronic gained FDA approval and a CE mark for the device back in 2012.
Josep Brugada, Medical Director of Hospital Clínic de Barcelona, told the HRS audience that the FIRE AND ICE TRIAL evaluating the Arctic Front technology was a game changer for AF Ablation.
Results of the study, which compared the first generation Arctic Front system to competitor Diamond Bar, Calif.-based Biosense Webster Inc.'s Carto system-guided Thermocool catheter, were released last year by the American College of Cardiology.
The trial demonstrated significantly fewer repeat ablations and lower hospitalization rates for patients with paroxysmal atrial fibrillation (PAF) treated with the Arctic Front Cryoballoon Catheter Family compared to the Thermocool line of radiofrequency (RF) ablation catheters.
Medtronic also released health economic analysis data from the FIRE AND ICE trial that favor cryoballoon catheter ablation over (RF) ablation related to trial period cost savings as a result of fewer cardiovascular rehospitalizations and repeat ablations. The data were presented at a late-breaking clinical trial session at the Asia Pacific HRS's Scientific Sessions in Seoul, Republic of Korea, last year.
"The impact of the FIRE AND ICE trial is that we have a less complex approach that is changing the way AF Ablation landscape," Brugada said. "We have shorter and more predictable procedures that will allow for more [AF] patients to be treated."
NEW BALLOONS ON THE BLOCK
David Haines, director of the heart rhythm Center, Beaumont Hospital, said the trend in AF ablation devices has "gone toward improving efficacy and decreasing time, so there's a great interest in single shot technologies."
He pointed to Campbell, Calif.-based Apama Medical Inc.'s balloon catheter solution that uses cryo energy to treat patients, as a technology to watch. The company has not yet received approval for the device.
Data from the AF-FICIENT FIH clinical study were released last year and show that all safety and performance outcomes were met as measured by successful PVI isolation and lack of serious adverse events at seven and 30 days.
The balloon has electrodes on the outside and tiny electrodes for mapping and perfusion for cooling. Haines said the device even had a little camera on the inside where a surgeon could see the balloon's contact with the tissue.
"There so much stuff packed into this balloon," he said. "It does allow for segmental ablation around the electrodes on the balloon's surface, and it does have reasonable efficacy."
Haines noted that one year follow up results are going to be presented this week at HRS.
Apama has been moving at a consistent pace. Last year, the private company revealed it closed $13 million in a series C financing from existing investors Ascension Ventures, Medvance Incubator Partners, Onset Ventures, Incept LLC, and various angel investors, along with up to $6.5 million in a debt facility with Silicon Valley Bank.
In 2015, the company raised $17.5 million in its series B round. Apama Medical is a portfolio company incubated out of Campbell, Calif.-based Shifamed LLC.
Another technology Haines mentioned that could make waves outside of the U.S. is the Toray Satake Balloon Thermal Ablation system. The technology is being developed by Toray Industries Inc.
A key difference between the TSB hot balloon ablation catheter and other balloon-based ablation systems is the TSB balloon is very compliant, designed to easily conform to variations in the pulmonary vein anatomy and optimize thermal energy delivery to the tissue.
"The balance of safety and efficacy was the delineating factor in that technology," he said. "We were hampered in terms of power delivery because of fear of excess risk to poor esophageal heating."
Haines added, in a pilot study of 38 patients, 63 percent were AF free and free from drug treatment,
"That compares favorably to all carefully monitored perspective clinical trials, but clearly not enough to raise this to a level of a superior technology," Haines said.
The data, however, is not enough to move the needle towards approval in the U.S. or in Europe.
Haines noted med-tech companies are continuing to churn out solutions for AF with no end in sight.
"You'd think after all these years we'd run out of new tech and new ideas, but that's anything but the case," Haines said.