CardioFocus is quickly positioning itself to be a dominant player in the growing atrial fibrillation (AFib) treatment market. Regulatory approvals coupled with triple-digit-growth are helping to shape the Marlborough, MA-based into a force to be reckoned with in a market filled with intense competition.
Last week, CardioFocus further strengthened its presence in the market by receiving CE mark for the HeartLight X3 System. The device is the latest generation of the company’s AFib treatment technology and could help the firm continue to thrive Europe, a market set to reach between 14 million and 17 million by 2030.
CardioFocus’ President and Chief Commercial Officer Omari Bouknight spoke with MD+DI last week about the HeartLight X3’s CE mark and plans to eventually bring the new generation of the technology to the U.S. market.
The HeartLight X3 System is a third-generation technology building upon the advanced features of the HeartLight Endoscopic Ablation System, which performs pulmonary vein isolation (PVI) using laser energy to create lines of scar tissue to block the abnormal electrical pathways that cause AFib.
“What makes the [HeartLight] X3 system unique is that it allows the user to create a continuous lesion around the pulmonary vein,” Bouknight told MD+DI. “This is the first time physicians can really do that. The traditional method has been using small points and trying to overlap those points to draw a circle around the vein.”
HeartLight X3’s European approval was based off results from a pivotal confirmatory evaluation of 60 patients. The study showed HeartLight X3 System consistently achieved very rapid PVI, in as few as three minutes for a single vein. The trial also found that the device has the potential to complete all required ablations in less than 20 minutes.
The product will be launched immediately in Europe and there are plans for the U.S.
“The U.S. market is of major interest to us,” Bouknight said. “We did have an initial approval for our first generation HeartLight Classic in April of 2016. Then we were able to get our Excalibur balloon approved by FDA in May of last year. The Excalibur Balloon was built on the same platform as the original HeartLight system. The HeartLight X3 is also built on the Excalibur balloon and the original system. We think that we will have a pretty good opportunity to introduce this technology into the U.S. market.”
Bouknight said it would probably have clarity on timeline of entering the U.S. market sometime in the second half of this year.
CardioFocus has to keep its ‘focus’ if it hopes to continue to drive growth in the AFib market. The space is filled with players in the medtech industry – that aren’t resting on their laurels.
Take Medtronic for instance. In August of 2018, the Dublin-based company reported results from the Cryo4Persistent AFib clinical trial at the European Society of Cardiology Congress. Data from the study was highly supportive of the technology and showed a low rate of re-interventions along with repeat ablations, and reductions in the symptoms abnormal heart rhythms.
Another firm making moves in the space is Atricure, which is in the process of conducting an IDE trial for the Convergent AFib treatment approach. The Mason, OH-based company reported last year it had completed enrollment of the full cohort of 153 patients in the CONVERGE IDE clinical trial.
Atricure said the last patient follow-up is expected to be sometime in 3Q19, after which the company would then be set to submit final documentation to FDA and seek a PMA. The news of the trial followed hot on the heels of Atricure being listed as one of the 25 most attractive medtech companies on the M&A radar.
Late last year, Johnson & Johnson’s subsidiary Biosense Webster launched an IDE study to evaluate the Heliostar radiofrequency balloon ablation catheter for the treatment of symptomatic drug refractory recurrent paroxysmal (intermittent) AFib.
Despite offerings from competitors, CardioFocus said its technology has a significant advantage over other devices in the AFib treatment space. The study will enroll up to 640 patients at as many as 40 clinical sites worldwide. Biosense Webster’s device has 10 electrodes, which allows electrophysiologists to deliver different levels of energy depending on the tissue during lesion creation. In addition, the balloon design makes it possible to achieve pulmonary vein isolation with a single application of RF energy.
Where Devices, Wearables, and AFib Meet
The AFib market received a huge spotlight in September of last year, when Apple received nods from FDA for its wearable watch to include an ECG app, that can classify whether there are signs of atrial fibrillation (AFib), and another app that analyzes pulse rates for irregular rhythms.
While the ECG app isn’t treatment per se, the Cupertino, CA opened up the door for collaborations that could have an impact on AFib. Earlier this year, Johnson & Johnson’s Janssen Pharmaceuticals slid through the door via collaborationwith Apple to look at how to help improve (AFib) outcomes, including stroke prevention, through the use of wearables.
Goals of the study include; measuring the outcomes of a heart health engagement program with irregular rhythm notifications on Apple Watch; and assessing the impact of a medication adherence program using an app from Johnson & Johnson.