Innovation has “created a tailwind for the company that that we haven’t had in a long time,”
Medtronic
CEO Geoff Martha said this week at the annual JP Morgan Healthcare Conference.
“These are growth-drivers across some of the most exciting markets in medtech,” he said. “… It started about five years ago with a renewed commitment to innovation, which is the lifeblood of the company.”
Founded as a pacemaker developer decades before it became the world’s largest medical device company, Medtronic is still innovating in cardiac rhythm management (CRM) with technology like its Micra leadless pacemakers.
But at JPM, Martha spent the bulk of his presentation on growth-driving medtech innovations in newer areas, including one minimally invasive therapy that he said “could be the biggest thing we ever do.”
Free webinar: Nitinol knowledge with former Edwards Lifesciences Engineering SVP Ming Wu
Cardiac ablation
Medtronic’s cardiac ablation portfolio now includes two
pulse field ablation
(PFA) systems approved by the FDA for minimally invasive pulmonary vein isolation to treat atrial fibrillation (AFib), with another PFA catheter on the way.
Related: How Medtronic designed the PulseSelect pulsed field ablation system for AFib
PFA is “a $9 billion segment growing [in the] mid teens, with a really strong growth runway in front of it,” Martha said, highlighting Medtronic’s FDA-approved PulseSelect and Affera Sphere-9 systems.
“Both of these are — in addition to being very competitive — the safest catheters out there,” he said. “We’ve got really strong safety data on both of these, and as we’ve seen over the last week, safety here really matters.”
Related: Medtronic’s Affera Sphere-9 dual-energy ablation and mapping catheter uses nitinol in a new way
Medtronic EVP and Cardiovascular President Sean Salmon was on hand for questions and addressed one about the pause of Varipulse PFA cases by competitor Johnson & Johnson MedTech after reports of strokes.
“I don’t think [the Varipulse catheter] had a whole lot of traction or interest anyway, with the attendant safety risks around it and a procedure that’s done electively to avoid the complication that seems to be appearing,” Salmon said.
Related: PFA catheters take shape at Medtronic, Boston Scientific, Abbott and J&J’s Biosense Webster
Martha said Medtronic is “significantly expanding our manufacturing capability” to meet “overwhelming customer response and physician demand” for the Affera system.
Medtronic recently secured FDA approval for a new Affera manufacturing facility in Galway, Ireland, Salmon said.
“That’s one of our marquee factories,” he said. “Really high quality, excellent volume coming out of there, so that’s going to help a whole lot.”
Martha said cardiac ablation is the area that he feels best about growth over the coming year.
“The ablation space [is] so big and our technology is the most comprehensive. We believe it’s the best — particularly Afferra — and it’s the safest, no matter who you compare it against, all players,” Martha said. “We won’t be done here until we’re in every center, because that’s the kind of demand we have for Affera in particular.”
The next big innovation in Medtronic’s cardiac ablation pipeline is the Affera Sphere-360 PFA catheter for single-shot ablation to treat paroxysmal AFib.
First look: Medtronic’s Sphere-360 pulsed field ablation catheter design has some new tricks
Hypertension
Meanwhile, Medtronic’s Symplicity Spyral
renal denervation
(RDN) system for treating hypertension “could be the biggest thing we ever do,” Martha said, citing the “massive” opportunity of more than 1 billion hypertension patients globally, with only 1% penetration equaling a $1 billion market.
Related: What is renal denervation? Medtronic Coronary and RDN President Jason Weidman explains
“Half of all heart-disease- and stroke-related deaths are caused by hypertension, leading to half a trillion [dollars] in direct costs in healthcare systems around the world,” Martha said. “… And if you have hypertension, it’s likely that you don’t have it under control: 75% of hypertensive patients do not have their blood pressure under control, and 50% of them stop taking their meds within one year. [Symplicity is] a safe, one time, very tolerable procedure. It’s always on, and it’s going to drive meaningful benefits to patients.”
Symplicity Spyral is “poised to transform hypertension management, and it’s a large opportunity that’s right in front of us — and I really mean right in front of us. … This has been over 15 years in the making,” Martha said.
Related: What Medtronic learned on its long road to RDN approval
With a national coverage analysis coming for RDN procedures, Martha said he couldn’t see any remaining obstacles to the widespread adoption of RDN.
“We’re not fighting pharma on this,” he said. “Patients like it. Physicians know how to do it. Health systems are behind it. There’s just nothing to stop it, and it’s going to be a lot of fun.”
Related: Medtronic execs say renal denervation for AFib could be on the horizon
Structural heart
Martha highlighted Medtronic’s Evolut FX+ transcatheter aortic valve replacement (TAVR) system as a key innovation in the structural heart space, which he quantified as $6 billion-plus market growing at high-single-digit rates.
“There are some skeptics out there who questioned our ability to grow our TAVR franchise as new entrants came into the market,” Martha said. “But we’ve shored up this business with new products, new data and better sales execution, and we’re seeing strong commercial traction of our latest-generation Evolut FX+ valve, which is designed to facilitate lifetime management and easier coronary access.”
“Engaging with customers on this new valve also allows us to reiterate the benefits of our technology as well as the clinical performance of our Low Risk and SMART trials,” he continued. “SMART demonstrated non inferior clinical outcomes and superior valve performance in patients with small annuli, many of them who are women, which is very underrepresented in clinical research. And we expect two year data from the smart trial later this year. And we remain committed to data transparency in patient outcomes, which is not always done in this space.”
Related: As cardiovascular deaths soar for women, Medtronic’s Nina Goodheart and the medtech industry are responding
The Intrepid transcatheter mitral and tricuspid valve replacement system are other structural heart innovation in Medtronic’s pipeline, and Martha also noted the company’s bid to win an expanded TAVR indication for moderate aortic stenosis.
Neuromodulation
In 2024, Medtronic VP and Brain Modulation GM Amaza Reitmeier told
Medical Design & Outsourcing
that
adaptive deep brain stimulation (DBS) was coming soon as the next big advance in neuromodulation
. Medtronic
announced a CE mark for that technology
the same day as Martha’s presentation this week.
“It’s the world’s first complete closed-loop DBS system with real-time, self-adjusting brain stimulation for patients with Parkinson’s disease,” Martha said.
With the devices already implanted in 40,000 patients, that makes it the “most-scaled BCI technology in the world,” Martha said.
Neuromodulation “has been a newer growth-driver for us,” Martha said. “Even though the business has been around a long time — we pioneered it — we’ve got a lot of momentum. … We’re in a strong innovation cycle, which enables even more innovation in the future. We’re working from a real position of strength, and we expect to remain the category leader. This is an area where the investments we’ve made over the several past several years in sensing technology in the brain and the nervous system are now paying off.”
Another neuromodulation innovation to watch for in Medtronic’s neuromodulation pipeline is its tibial implant for overactive bladder.
Diabetes
Martha said smart dosing for diabetes patients “is expected to dominate by the end of the decade, as CGM alone is just not sufficient for this patient population,” Martha said.
“We remain the only company investing in a comprehensive ecosystem of differentiated technology for intensive insulin patients that takes more of the work of the diabetes management off their plates,” he continued.
Martha described Medtronic’s new Simplera Sync sensor as “half the size and much easier to apply than our previous sensor,” and said there are more sensors in the pipeline, as well as next-generation AID systems including the 800-series pump and patch pump technology.
Related: Medtronic’s MiniMed chief engineer on designing human-machine interfaces and automated systems
Surgical robotics
What about Hugo? Martha reported “a lot of progress” on Medtronic’s surgical robotics platform, with year-over-year procedure volumes doubling.
“We’re confident in our position to become a strong No. 2 player in the surgical robotics space,” Martha said, without mentioning surgical robotics leader Intuitive by name. “Usually we’re targeting No. 1, but right now we’ll just target No. 2 here, and I think that’ll be pretty good.”
Medtronic plans to file with the FDA for a urology indication before April, and Martha said enrollment is progressing quickly for the next two U.S. indications: hernia and gynecology.
“We’re leveraging data and AI capabilities in intraoperative solutions with Touch Surgery that will continue to advance this technology. We’re also making progress on bringing our advanced surgical technologies to Hugo with ICG (an abbreviation for indocyanine green) visualization technology, and we look to add our market-leading ligature vessel sealing technology this calendar year.”
During his presentation, Martha mentioned the articulating catheter technology Medtronic acquired from Fortimedix Surgical in 2024, noting that it has robotic and non-robotic applications.
“Our big businesses — our CRM, our spine business, TAVR, ENT and others — are fortified with innovation and growing well, and then we’re stacking growth-drivers on top of it,” Martha said. “… We’re well positioned in the moment, tomorrow and out into the future with with innovation.”
