Spotlight – J&J takes on Medtronic and Boston in pulsed field ablation
The group is fast developing its new atrial fibrillation devices. But will it be fast enough?
On its first quarter earnings call J&J singled out its Varipulse pulsed field ablation catheter as a crucial product to sustain growth. Pulsed field ablation, a treatment for atrial fibrillation, is safer than current ablation techniques and is expected to replace them in the next few years.
But J&J has two major competitors in the cardio behemoths Medtronic and Boston Scientific, and is expected to reach market behind both. Moreover, another interested party, Abbott, might fight its way into this space via M&A.
Current cardiac ablation catheters scar the heart muscle either using radiofrequency energy or by freezing the tissue. The scars stop the cardiac tissue conducting the faulty electrical signals that cause atrial fibrillation (AF). J&J is the undisputed leader of the $8bn worldwide ablation market thanks to its Biosense Webster subsidiary, which has a 60% market share, according to Stifel analysts. Abbott has 20%, Medtronic 15% and Boston Scientific the remaining 5%.
Finger on the pulse
But times are changing. Pulsed field catheters, which deliver electric pulses to interfere with the irregular electrical pathways in AF patients, appear to be both faster and more precise, causing less unnecessary damage to the heart than RF or cryoablation. They are widely expected to take over from the older tech, with some analysts suggesting that they will usurp almost the entire market over the next decade.
Inspire, the European pivotal trial of J&J’s pulsed field device Varipulse, hit in February, and the US trial ought to read out next year. On the group’s first-quarter earnings call Ashley McEvoy, head of J&J’s medtech division, declined to give an approval timeline, but the device is probably a year or two away from the US market.
Medtronic also posted data recently. The Pulsed AF US trial of its rival catheter PulseSelect was a success at last month’s ACC meeting, however because this trial had a very different design from J&J’s Inspire study effectiveness comparisons are tricky. US approval could come later this year or early next.
Boston Scientific, the smallest player in traditional ablation, is leading the race in pulsed field, albeit via dealmaking than in-house development. In 2021 it bought Farapulse, whose catheter of the same name, pictured above, had been CE marked a few months earlier. To its credit, Boston had taken the option to buy Farapulse before the approval came through.
Abbott is not sponsoring any ongoing clinical trials of pulsed field ablation, but it is interested. On the company’s fourth-quarter call in January its chief executive, Robert Ford, said pulsed field was “an important product to have”, adding that while it was too early to say whether the market would move completely over to this technology, Abbott was investing in a pulsed field programme.
Still, a few smaller companies including Kardium and Adagio Medical are also working on pulsed field catheters, and takeouts here cannot be ruled out. As the only ablation player without a late-stage presence in pulsed field, Abbott must surely be aware that an acquisition of a device would be the quick and easy way to become a contender.
The real opportunity here, however, might not be pulsed field alone but bringing to market catheters that can use two ablation methodologies at once.
“We actually think access to radiofrequency, which has 20-plus years of safety and efficacy, coupled with the newer generation of [pulsed field] is really going to be the winning combo for electrophysiologists,” J&J’s McEvoy said last week.
The company is studying a device called Thermocool Smarttouch SF dual energy, which is intended to marry the relative safety of pulsed field with the proven durability of radiofrequency ablation. The first procedures have been conducted in the European Smartfire study, which could yield data later this year.
Medtronic is pursuing a similar second-generation system. The pivotal US trial of its Sphere-9 device could report next year.
While J&J looks on course to be third to market with a single-method pulsed field system, it could be the pioneer in the second-generation space. This market is moving fast, and these new technologies should command premium pries over older ablation products. There is much to play for.
|Pulsed field ablation catheters|
|Company||Device||Trial status||Approval status|
|First-gen (pulsed field energy only)|
|Boston Scientific||Farapulse||Advent, US trial in 900 pts w paroxysmal AF, could report H2 2023; Advantage AF, in 417 pts w persistent AF, could report 2024||Approved in EU 2021; US approval poss 2024|
|Medtronic||PulseSelect||Pulsed AF, WW trial in 421 pts w either paroxysmal or persistent AF hit Mar 2022||US approval poss mid to late 2023|
|Johnson & Johnson||Varipulse||Inspire, European trial in 550 pts w paroxysmal AF hit Feb 2023; Admire, US trial in 362 pts w paroxysmal AF, could report 2024||US approval poss 2024-5|
|Kardium||Globe||Pulse-EU, European trial in 110 pts w unspecified AF, could report 2024; Pulsar, WW trial in 449 pts w paroxysmal or persistent AF, could report 2025||Unclear|
|Adagio Medical||Adagio PFA system||Parallel, WW trial in 78 pts w persistent AF, could report 2024||Unclear|
|Second-gen (pulsed field plus radiofrequency)|
|Johnson & Johnson||Thermocool Smarttouch SF dual energy||Smartfire, European trial in 135 pts w paroxysmal AF, could report 2023-4||US approval poss 2024|
|Medtronic||Sphere-9||Sphere-Per AF, US trial in 477 pts w unspecified AF, could report 2024||US approval poss 2024-5|
|Source: Evaluate Medtech, Stifel & clinicaltrials.gov.|