“The key is that myocardial tissue is uniquely susceptible to this pulse-field energy source. And as a result, you can irreversibly damage myocardial tissue without irreversibly damaging surrounding tissues.
• Dr. Kenneth Stein is SVP and CMO of CRM at Boston Scientific, which acquired Farapulse in 2021. The Farapulse PFA treated nearly 2,000 patients in nine European countries last year. It has a CE mark, and Boston Scientific is seeking FDA clearance.
• Dr. Khaldoun Tarakji is the CMO of the Cardiac Ablation Solutions operating unit at Medtronic. The medtech giant is in the process of completing a global clinical trial of its PulseSelect PFA system. It’s conducting the study in the U.S. under an FDA investigational device exemption. Medtronic also announced in January that it plans to acquire cardiac mapping and ablation technology developer Affera for nearly $1 billion. The plan is for the deal to close in the coming months.
• Dr. Steven Mickelsen founded Farapulse and is presently the chief translational science officer at Acutus Medical. The Acutus PFA system is under investigation in CE mark countries.
Top experts at Boston Scientific, Medtronic and Acutus Medical shared insights about pulsed-field ablation’s potential at DeviceTalks Boston.
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It’s hard these days to find a cardiac device company that is not doing something related to PFA. At our DeviceTalks Boston conference and expo in May 2022, we were lucky enough to have a panel of executives from three of the leaders in the space:
ulsed-field ablation is a nonthermal method for cardiac ablation that has the potential to positively disrupt the way atrial fibrillation (AFib) is treated.
Here are some key takeaways from the panel, lightly edited for length and clarity: 1. PFA could be safer, faster and more Stein:effective.
PFA’s roots go back to the dc ablation tech of the 1980s. These days, PFA generally involves high-voltage electric pulses from a catheter-delivered electrode or electrodes, each delivered at a tiny fraction of a second. Its potential advantages versus radiofrequency ablation or cryoablation include the characteristic that heart muscle tissue can be especially susceptible to it, while other types of surrounding tissue are injury resistant.
What is pulsedfield ablation? Here's what you need to know
Part of the Farapulse pulsed-field ablation system, the Farawave single-shot catheter is designed to create durable and circumferential lesions. Image courtesy of Boston Scientific September 2022 www.designworldonline.com
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Farapulse founder and ChiefScienceTranslationalOfficeratAcutusMedical
you’ve got a reversible field. And so the proof of the pudding isn’t until you do three-month remaps, or you wait and look at your one-year chronic results. >> It’s very easy to fool yourself early. That’s part of why the development path for the Iowa Approach, which became Farapulse, took too long. And then the second thing I’d say, which was one of the things that I think Farapulse did really well, is not just taking an RF catheter and trying to push PFA through it. Actually design a catheter from the ground up to use this energy source. You can put wings on a boat and tell people to fly it, but you don’t want to be a passenger in that airplane.”
SVP and CMO of CRM at Boston Scientific Dr. Kenneth Stein CMO of the Cardiac Ablation Solutions operating unit at Medtronic Dr. Khaldoun Tarakji
3. There are different approaches. Mickelsen: “What Acutus is looking at is that we need a flexible format that really highlights our ability to see and map AFib in real-time and choose targets based on that. And so one-size-fits-all didn’t necessarily meet the strategy of the company. That’s why we went with a point-by-point version of PFA. But I think every single company that’s in the space is going to have at least some offering that is a single shot, very simple, that doesn’t require the technical skills of moving around a deflectable catheter and the atrium for the purposes of a [pulmonary vein antrum isolation] tool. And then I think every one of the players in the field is also going to have a point-by-point offering because even if you do all your AFib ablation, you still have 50% of all ablations done on Earth that are not AFib.”
2. There are a lot of variables around PFA, and it’s going to take time to prove Mickelsen:results.“The field right now is very full with a lot of different strategies or recipes for pulse field. With RF — an oscillating wave where you get heating and it’s predictable — there’s a pretty narrow kind of bandwidth used universally throughout the field. But with PFA, there are a lot of options. That recipe can be a whole bunch of different engineering ways of playing with the knobs. And what I’m hoping to see is over the next five to 10 years is a convergence on what recipe works best for the heart.”
So there’s a promise that ablation for atrial fibrillation is safer because you can avoid collateral damage. Because of that, you can ablate in areas a little more aggressively than you can with thermal techniques. And therefore, there’s a promise that it may be more effective than conventional thermal techniques. And then depending on the format of the catheters, the generator and the workflow, it clearly can be much faster than conventional energy sources. There are very few times in medicine, engineering or life where you ever get that trifecta of safer, more effective and faster. As long as we can prove out in clinical trials that it lives up to that promise, it will revolutionize ablation therapy.”
Tarakji: “I think the combination of durable lesions, effective therapy — at the same time achieving safety — that’s probably the main driver for the excitement in the EP [electrophysiology] community for pulsed-field ablation.”
Stein: “Every RF lesion in any catheter — if it’s the same sized catheter tip and the same back patch, it’s the same lesion. PFA is very much dependent on the particular waveform, the particular energy source and the particular workflow. And one of the things to watch out if you’re trying to create your own PFA startup is to remember the biophysics. The irreversible field of injury — that is always surrounded by a large field of reversible electroporation. One of the things you learn really fast when you start doing this is you’ve got to try really hard to get bad acute results with PFA. It always looks great acute, because even if you haven’t been irreversible, "There's a promise that ablation for atrial fibrillation is safer because you can avoid collateral damage. Because of that, you can ablate in areas a little more thermalthanaggressivelyyoucanwithtechniques."
Dr. Steven Mickelsen
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4. There’s still a need for innovation. Stein: “If someone had a way of knowing they can interrogate and tell whether tissue is reversibly versus irreversibly electroporated, that would advance the field substantially.”
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Tarakji: “You can achieve electrical silence, but that doesn’t give you the confidence of whether it’s going to be reversible or not. … Defining electrical silence, that’s easy. You put your catheter in, you can see that. But what’s reversible, what’s not? I agree, there’s still a lack of ability to do this.”
Stein: “No one goes out to play golf with just a single club in their bag, unless it’s me playing miniature golf. Ablation takes a lot more than just that. There is a question of integration with 3D. We have anatomic mapping systems, there’s the issue of transeptal access. We’re really excited about the technology that Baylis Medical [acquired by Boston Scientific for $1.75 billion] brought to us in terms of transeptal crossing. It can also come to what other things does a patient need? Do they need left atrial appendage closure with something like the Watchman device? We as a company try to look at ourselves as not just providing widgets for people who need widgets to treat their patients, but to really provide a comprehensive toolset for the overall management for patients with atrial fibrillation.”
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Image courtesy of Boston Scientific
K evin Sayer began thinking about automated insulin delivery all the way back in 1994 when he was working at MiniMed.
(continued on page 138) The Dexcom G6 CGM product family Photo courtesy of Dexcom 2022
136 Medical Design & Outsourcing 7 • 2022 www.medicaldesignandoutsourcing.com
In the '90s, MiniMed ran trials with a fully implantable system before Medtronic bought the company. Sayer admits the system with an implantable pump and sensor wasn't particularly practical, but it planted the seeds for what could grow.
"I've often asked myself the question, 'How big does this get?' The feedback I'm hearing from users of both Tandem's system and [Insulet's] Omnipod 5 is incredibly positive.
"I've been around the fringes of this for a very long time," Sayer told Drug Delivery Business News during the American Diabetes Association (ADA) Scientific Sessions in June.
136 September
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With the G7 nearing FDA clearance, Dexcom leadership foresees major innovations for integrated automated insulin delivery down the line.
Now with Dexcom, the maker of the leading G6 continuous glucose monitoring (CGM) system — and the next-generation G7, which is expected to receive FDA clearance soon — Sayer has seen the integration of CGM with automated insulin delivery through partnerships with Insulet and Tandem Diabetes Care. He believes room for growth remains, with pump penetration not yet passing 50% of intensive insulin users.
Nearly 30 years later, as CEO of Dexcom, that space continues to pique his interest.
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Recent rumors put Dexcom in the mix to enter the automated insulin delivery space itself, with Bloomberg reporting that the company was in talks to acquire Insulet.
I think this is going to be a very important part of our business going forward." Sayer said G7 offers an even better opportunity over time because it is 60% smaller than the G6, which "decreases the amount of real estate on the body."
"So, then, how does Dexcom play into this? The most important element is giving somebody an accurate glucose reading that is communicated on a timely basis. The second-most-important element is an algorithm that can drive that outcome, and we've got access to both, and we've got partners who can use it. We're very excited about the future here."
Once it garners FDA clearance, the integration into Tandem's and Insulet's systems will further highlight the benefits of the next-generation CGM. Dexcom owns the algorithm that represents the basis of Tandem's t:slim X2 insulin pump. Sayer said he sees the analytics angle as a "bright" future component of what the company does.
Dexcom has to incorporate artificial intelligence algorithms with data collected from its technology to find new and improved ways to help people manage their diabetes, he said.
"I think you'll see a science boom over the next 10 years with this stuff," Sayer said. "It can give people opportunities to pretty much get out of their diabetes care and let systems do it. Right now, we're not there, and there'll be a lot of trials and a lot of pain.
The Dexcom G7 continuous glucose monitor Photo courtesy of Dexcom The Dexcom One Photo courtesy of Dexcom 138 September 2022 www.designworldonline.com DESIGN WORLD
DEXCOM ‘SCIENCE BOOM’
DEXCOM ‘SCIENCE BOOM’
"Our focus will be on supporting our partners and helping the technologies that can best serve that space," he said.
"It's a give and take, back and forth, and the FDA has been very involved with us in discussions," Sayer said as ADA came to a close last month. "Would we like to be in all these discussions? No. Would we like to be done? Absolutely. But, we understand that, if they're going to grant us all-iCGM status where we're integrated with insulin delivery systems, they're entitled to ask a bunch of questions, because people's lives depend on this."
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Suggestions of a merger between the two diabetes tech giants were quickly put to rest when Dexcom issued a statement saying it is not in active discussions regarding any such transaction. The company said it did not intend to comment further on the matter, and Sayer declined to offer a comment a week after.
G7 excitement Plenty of focus remains on Dexcom's next-generation G7, which could be picking up FDA clearance any day now. Sayer earlier this year said clearance may come after ADA.
The platform features a nearly two-thirds size reduction, a 30-minute warmup period (down from waiting two hours for glucose readings to begin in the past) that offers reliable data after just that half-hour period, more information in one place with personalized insights, extended-wear design and more. Over Zoom, Sayer demonstrated the simplicity of the G7 experience, with the process containing very few steps. He opened a box, unscrewed a cap and showed that all the user has to do is place The Dexcom G6 (left) compared to the G7 (right) Photo courtesy of Dexcom 139
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Sayer echoed Leach's sentiment, pointing to the launch of Dexcom One — an easy-to-use, real-time CGM (rt-CGM) that it aims to make more affordable and accessible with a wearable sensor and transmitter to continuously monitor glucose levels and send real-time values wirelessly to a compatible smart device via the Dexcom One mobile app. Dexcom One was recently launched in the United Kingdom, and Sayer said there's a coming launch in Spain, too. The company also received FDA breakthrough device designation for the use of CGMs in hospitals. Sayer said they've assembled a team that features hospital device experience so Dexcom will be ready for full approval.
140 September 2022 www.designworldonline.com DESIGN WORLD FREE CATALOG Small Mechanical Components Stock and Custom • One Single Source Precision Gears and Gearboxes Timing Belts & Pulleys MotorGearheadsBearingsCouplingss Call Us at 516-328-3300 or Shop SDP/SI at www.sdp-si.com We have the expertise, state-of-the-art CNC machinery and world-class manufacturing facility you need. Check out our Engineering Resources DEXCOM ‘SCIENCE BOOM’ the apparatus on their body and push a button to apply the sensor."Everybody who's on it, they're never going back to what they had before," Sayer said. "Nobody's going back to G6. Nobody's going back to wearing no sensor. They absolutely love it. I think it'll be a wonderful product for us."
walk [at ADA] and everybody I talk to, Dexcom has become part of their company, part of their lives," Sayer said. "We really are dialed in here and have made a lot of progress. I think the future looks amazing."
And while clearance for G7 looms, G6 is still performing at a high level, with one study presented at ADA highlighting users in Belgium who switched from Abbott's FreeStyle Libre to Dexcom's G6 and experienced marked improvement over three years, Sayer Analystsnoted.areoptimistic about Dexcom and its upcoming offerings. BTIG’s Marie Thiabult wrote that the company is experiencing strong adoption trends as the introduction of G7 in the U.K. is “going well.”
Dexcom's expanded portfolio G7 isn't the only exciting technology at Dexcom, as Jake Leach, the company's chief technology officer, told Drug Delivery Business News in April. “We are producing a portfolio of products,” Leach said. “We’re differentiating our portfolio."
“Underlying business indicators are stable,” Thibault said. “We remain bullish on long-term, broad-based growth for CGM adoption.”Sayeragrees."EverywhereI
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