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Stryker Set for Unprecedented M&A Run
By Omar Ford
Stryker has closed its acquisition of Vertos Medical, a little more than a month after the deal was first announced. This marks the fourth deal the Kalamazoo, MI-based company has been involved with since August.
Vertos specializes in interventional pain management solutions for chronic lower back pain caused by lumber spinal stenosis.
Spencer Stiles, group president, for orthopedics and spine spoke about the deal in September, during the Stryker Corporation Wells Fargo 2024 Healthcare Conference.
“It's a really unique, minimally invasive way to do some soft tissue resection that removes some of the strain on the spinal cord that's causing this pain on some of the nerves,” Stiles said of Vertos’s therapy, according to a Seeking Alpha transcript of the call. “What's great about that? That's much earlier in the care environment and treatment for somebody versus a fusion. And what's wonderful? There are great clinical results behind that procedure. There's great growth. There's a significant patient population that qualifies for those particular procedures. And for whatever reason, if it doesn't work the way that its planned, it's not perfect, but if it doesn't, you still have these other interventions later on in the care environment, something like a fusion, for example.”
Stryker has been on an unprecedented acquisition spree. While it doesn’t top the nine deals Boston Scientific announced in 2018, what stands out about Stryker’s run is it’s quickness in closing the acquisitions.
“It's been a really good M&A season for us,” Stiles said according to a Seeking Alpha transcript of the call. “So, I'd leave us with that. We've been active again. Our expectations remain high there. Focused on tuck-ins, but we have some other things that we're looking at as well, and we expect more deals in our horizon.”
This Medical Device Has a Scary History
Back in 2014, MD+DI published a list of the scariest medical devices of that year. Topping the list was Thoratec's HeartMate II left ventricular assist device (LVAD).
Interestingly enough, the problem at that time had nothing to do with the LVAD itself, but user error due to not understanding instructions and lacking the training needed to hook up a backup system controller in cases of device alarm or malfunction.
Nevertheless, the problem resulted in four patient deaths and caused five other patients to lose consciousness or experience reduced blood flow.
FDA explained at the time that all reports were linked to patients whose HeartMate II device was originally attached to an older model of controller. When a new controller became available, patients were switched to the new controller but did not receive intensive training on connecting the new controller.
Fast forward 10 years, and the HeartMate 3, which Abbott inherited through its acquisition of St. Jude Medical (St. Jude acquired Thoratec in 2015), has been the subject of multiple recalls.
The life-saving heart pump, which has helped more than 30,000 people worldwide live longer, more active lives has now been linked to at least 273 injuries and 14 deaths.
Abbott recalled its HeartMate II and HeartMate 3 left ventricular assist systems due to a problem called extrinsic outlflow graft obstruction caused by longterm buildup of biological materials between the outflow graft and the outflow graft bend of HeartMate systems.
Typically, it takes buildup of more than two years to cause such an obstruction in the device. An obstruction makes the device less effective in helping the heart pump blood, according to an FDA notice tagging the?HeartMate recall?as a class I recall, the most serious type. FDA noted, however, that the recall was a correction, not a product removal.
Abbott asked customers via an urgent medical device correction letter to pay attention to low-flow alarms as this is the first indication of significant outflow obstruction.
How the HeartMate systems work
The HeartMate II and HeartMate 3 are used for both short- and long-term support in adult patients with severe left ventricular heart failure. The technology can be used as a bridge-to-transplant therapy for patients waiting for a heart transplant, to help the heart recover, or as a permanent solution when a transplant is not an option. HeartMate 3 can also be used in pediatric patients.
The HeartMate devices are designed to take over the pumping function of the left ventricle, the main pumping chamber of the heart. They divert blood from the weakened left ventricle and propel it into the aorta, helping to circulate blood throughout the body.
Medtronic’s PulseSelect Study Paves the Way for PFA
By Omar Ford
Pulsed Field Ablation (PFA) procedures gained a big victory after Medtronic revealed favorable data for the PulseSelect system.
领英推荐
The Results presented at the Asia Pacific Heart Rhythm Society (APHRS) meeting in?Sydney, Australia, show that the Dublin-based company’s PulseSelect demonstrated excellent lesion durability.
A total of 25 AFib patients with persistent or paroxysmal AFib (56% paroxysmal, 52% male, 69±9 years) undergoing pulmonary vein isolation (PVI) with the PulseSelect PFA System were evaluated.
Invasive remapping conducted in all patients (57±9 days post-ablation) demonstrated durable isolation in 98% of PVs (102/104), and 96% of patients (24/25) had all veins isolated.
"These important results clearly address the durability question and add to the real-world evidence for PulseSelect," said?Rebecca Seidel, president, Cardiac Ablations Solutions business, which is part of the Cardiovascular Portfolio at Medtronic. "With expansion in new markets across the?Asia Pacific?region, physicians around the world are experiencing the benefits of PulseSelect, including proven safety, efficacy, efficiency and now durability as well. We are thrilled to provide this important tool to physicians for the treatment of patients with AFib."
The company said the broad adoption of PulseSelect continues worldwide, with more than 10,000 cases being performed worldwide. In the?Asia Pacific?(APAC) region, milestones include regulatory approvals in?China?and?Australia?and launch in?Japan?following reimbursement approval.
PFA procedures to treat atrial fibrillation have been on the upswing since late last year. In December, Medtronic was the first company in the space to win approval in the PFA market in the US – making it to the finish line before Boston Scientific and Johnson & Johnson.
Boston Scientific followed shortly, winning approval for the Farapulse PFA in January. The device was one of the most highly-anticipated medical device approvals of 2024. Marlborough, MA-based Boston Scientific began investing in Farapulse in 2014. The company signaled its intent to buy Farapulse in 2020 and acquired the company in 2021 after the device was CE-marked.
Johnson & Johnson is still seeking approval. However, earlier this year, the company unveiled promising results from the inspIRE for the Varipulse System at the 29th Annual International AF Symposium.
Yes, People Still Play Pokemon Go – Here’s Why Medtech Should Care
“People still play that game?”
This is by far the most frequently asked question when the subject of Pokémon Go comes up in front of non-players.
My husband and I have been playing the augmented reality game since it launched in July 2016 and became a worldwide cultural phenomenon practically overnight—breaking revenue records at $207 million in the first month.
I’m not the avid player I once was, but I still get a little dopamine boost when I catch a new “shiny” Pokémon or complete one of Professor Willow’s special research challenges.
It wasn’t until a recent conversation with colleagues that I fully realized Niantic, the developer behind Pokémon Go, has truly mastered audience engagement—something many industries, especially medtech, are still working to achieve.
In the past 30 days, Pokémon Go has had 90,378,910 active players. Even at 5:30 am U.S. Central Time today, there were more than 650,000 people logged into Pokémon Go, according to the live player count.
So yes, people still play that game. But beyond the numbers, the question for medtech professionals is: What can be learned from this massive, sustained engagement?
This is particularly important as we’ve witnessed numerous digital health and traditional medtech companies try, with mixed results, to embrace emerging technologies like augmented reality.
Earlier this year, for example, orthopedic surgeons at Mayo Clinic and St. Joseph’s Health Care London, in Canada, used Stryker’s Blueprint Mixed Reality (MR) Guidance System in shoulder arthroplasty surgeries. The Blueprint MR system combines Stryker’s software with Microsoft’s HoloLens 2 headset and allows surgeons to track the position and orientation of surgical instruments.
Despite examples like Stryker’s, many companies are grappling with the same questions: how can they drive sustained user engagement, and how can augmented reality achieve its full potential in medtech?
One company that came close was Akili Interactive, which had embraced gamification for ADHD. Once valued at $1 billion, the company was acquired this summer by Virtual Therapeutics for just $34 million after Akili had struggled with reimbursement challenges. Granted, Niantic hasn’t had to worry about reimbursement for any of the augmented reality games it has developed, but I can’t help but wonder if Akili’s story would have had a happier ending if it had engaged a partner like Niantic.
The AR gaming company does appear to be open to partnership opportunities. Specifically, Niantic is currently engaging its players and developers in an endeavor to create a new 3D map made for special experiences and anchoring digital content precisely within the physical world with its Niantic Visual Positioning System. I can think of countless ways medtech firms would benefit from adopting such a technology.
The lesson here is simple: engagement is everything. Medtech companies can’t afford to focus solely on technology—they need to think like Niantic, constantly adapting to maintain engagement and create meaningful interactions. By embracing strategies from industries outside their own, particularly gaming, they might just find themselves “catching” the next wave of innovation.
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