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Medos’ Cerenovus Cerebase DA Guide Sheath Recall Categorized as Class I
The recall comes after reports of cracking at the distal catheter shaft, possibly resulting in patient injury.
By Katie Hobbins, Managing Editor
Medos International Sàrl recently announced the recall of its Cerenovus Cerebase DA Guide Sheath after reports of cracking at the distal catheter shaft.
The guide sheath is categorized as a neurovascular catheter and is commonly used in procedures that require precise navigation and access to blood vessels in the brain. Designed to help deliver interventional devices into the blood vessels in the brain, the catheter allows for the placement of devices like stents or coils — treating neurovascular diseases and conditions.
The recall, identified as Class I by FDA, concentrates on complaints describing fractures of the distal catheter shaft. These potential cracks are found at the far end of the device that is placed into the brain, where different parts of the catheter join. Use of the affected product, according to Medos, may result in surgical procedural delay, vascular injury or hemorrhage, and, in extremely rare occasions, embolism. The company has reported 3 injuries connected to the recall and no deaths.
On Feb. 2, Johnson & Johnson Medtech, on behalf of Medos, sent an Urgent Medical Device Recall to all affected customers, recommending they examine inventory and quarantine any recalled product, remove all recalled products, communicate the issue to anyone who needs to be informed, and contact any facility where affected products may have been forwarded to arrange a return.
Currently, 1,343 devices have been recalled in connection with the issue. The affected devices were manufactured on July 7, 2023, and later, then distributed between June 14, 2023, and Dec. 14, 2023.
Behind the Design: Form Follows Function in New L-Shaped Widex Hearing Aid
A Widex product designer shares insights behind the design of the company's newest hearing aid.
Widex – the developer of the hearing aids that were music to my husband’s ears three years ago – seems to have outdone itself in terms of innovative hearing aid design.
The company recently launched the Widex SmartRIC, an L-shaped hearing aid designed to improve microphone angles to enhance hearing across listening environments.
By placing the SmartRIC higher up on the ear, the angle between the device’s two microphones becomes closer to horizontal. This enables the directional microphone to align with what wearers are focusing on, the idea being that it will improve the user’s signal-to-noise ratio, regardless of their environment.
In addition to the L-shaped angle, Widex has made several other design enhancements to craft an elegant and seamless device that lets wearers enjoy the freedom of not having to think about their hearing aids when they are on the go.
MD+DI connected with Martyn Beedham, an industrial designer for WSAudiology, Widex’ parent company, to glean product design insights from the Widex SmartRIC project.
What’s up with the L-shape design of the new hearing aid?
“In a way, it’s very simple. It's the old adage of form follows function,” Beedham said. “So, obviously, we want to deliver better hearing, we want people to have a device that is comfortable to sit behind the ear easily even if you're wearing glasses, we want something that's easy to use, and of course we want something to be appealing as well because as you can imagine – and maybe you know from your own experience – people are still not thrilled about having a hearing aid.”
So, the task was to design a Widex hearing aid that functioned well enough to improve the user’s ability to hear and communicate, but also to make wearing hearing aids easier.
“Every rechargeable hearing aid has a battery inside and this is no different. But what's different here is how we've arranged those components,” Beedham said. “And we've arranged that so that it is specifically performing better, it's also slimmer behind the ear, that means it's more comfortable, it's also discreet behind the ear. So, we're really trying to tick all those boxes and hit all those notes where we can get everything as good as we possibly can.”
The Widex SmartRIC is the company’s best performing and slimmest hearing aid today.
"I'm designing things nobody wants."
There's a lot of stigma attached to needing a hearing aid, and Beedham said Widex wants to destroy that stigma through product design. For many people when they think of a hearing aid, they picture something akin to a "big beige banana," he said.
"When I first started this job I always said, 'I'm designing things that nobody wants.' And that always felt like an odd position because as a designer, you want to be designing the cool stuff. But for me, this is the cool stuff."
Dare to take design risks
In any great design project, there are always things that don't go as expected, presenting challenges that must be overcome. In this case, Beedham said the key challenge was overcoming fear of risk.
“When you do something different, of course there is going to be a bit of fear ... you could say, ‘we’re just always going to play it safe and we’re never going to do anything differently’ so, I do think to a certain extent there were some concerns. Of course, people are rightly concerned that if you step outside the norm and do something outside the box there are concerns,” Beedham said.
The teams involved with the project – from designers like Beedham to audiology electronics engineers and project managers – overcame that fear of risk by following a robust design process.
“We have this good process in place, and we brought everybody along in the process,” he said. “Because it’s so new and it’s so different it always takes a bit more time. And in any business, time is money, and that money is an investment into what we want to do for the future.”
The team conducted thorough design research by hitting the pavement, so to speak, and talking to customers and doing human factors studies to inform the design of the new product.
“And I think it’s really paid off with an absolutely unique product,” Beedham said. “... What's interesting for me is that looking at this project there are already now more people coming and saying, ‘We want to do more, we want to go further, let's do that again.’ So, I think doing things right and doing it in a robust way, doing it with the right people behind it ... success breeds success.
The power of portability, with a ‘bit of magic’
As with the Widex Moment hearing aid, the Widex SmartRIC comes with a charger. What’s different about the new model, however, is that this time the charger itself is a portable, compact, battery-powered case. That means users can recharge their hearing aids even when they’re not connected to a power supply. This would have come in handy earlier this week when one of my husband’s hearing aids hadn’t charged properly overnight and died shortly after he arrived at work.
So, not only is the SmartRIC the company’s longest-lasting rechargeable receiver-in-canal (RIC) hearing aid, providing up to 37 hours on a single charge, but the hearing aid case is designed to fully charge the hearing aids in four hours. If the user can’t wait that long, a 30-minute fast charge will buy them up to eight hours of continuous use. What’s more, the case offers five full charges before it needs to be connected to a power source, offering the hearing aid user more than a week of off-the-grid hearing.
“That obviously gives you a lot of freedom, a lot of peace mind, you can go away for a weekend or longer depending on how long you use your hearing aids without that worry of not being able to recharge,” Beedham said. “We put a lot of effort into our chargers because the charger is a highly important part of the whole ecosystem.”
He said the team integrated the LED display into a hidden panel so the LEDs are hidden behind a metallic strip.
“When you open the charger, it lights up and the LEDs come on and it's a bit of magic,” Beedham said. “...It feels more sophisticated, it’s also more discreet than having something with flashing lights all over it. We put the same care and attention into the accessories that we do into the hearing aid.”
Music to a designer's ears
While the Widex hearing aids, especially the Widex SmartRIC, are designed with discretion in mind, these modern hearing aids are so different from the hearing aids of the past that a lot of users are actually proud to show them off.
During the usability studies some people commented that they would take their Widex SmartRIC hearing aid off to show people how cool it is. And that, Beedham said, is music to his ears.
New Cardiovascular Company Emerges from Stealth Mode
Fresh off a $42 million series A financing, Reprieve Medical is developing an intelligent automated fluid management system for heart failure patients.
Reprieve Cardiovascular recently emerged from stealth mode after raising $42 million in series A financing.
The Milford, MA-based company is developing a system intended to personalize decongestion management and remove excess fluid to improve patient outcomes and prevent hospital readmissions. The Reprieve System monitors physiological parameters such as urine output to deliver personalized diuretic dosing and fluid replacement for patients with acute decompensated heart failure (ADHF).
“Today, the standard of care for heart failure patient fluid removal is diuretics. Originally approved 60 years ago, diuretics remain the primary treatment option but can be difficult to administer optimally without real-time patient information,” said CEO Mark Pacyna. “Reprieve Cardiovascular is bringing intelligent decongestion management to heart failure patients. The Reprieve System provides physicians and care teams added visibility and control throughout treatment.”
Reprieve expects to use the funding to advance its clinical and development programs, including an ongoing FASTR trial and an upcoming pivotal trial. Lightstone Ventures and Sante Ventures co-led the round, which also included Deerfield Management, Genesis Capital, and Arboretum Ventures.
While in stealth mode, Reprieve has been growing its leadership team. Pacyna joined the company in May 2021. Before Reprieve, he spent 16 years at Medtronic in various leadership positions, most recently as VP and general manager of Medtronic’s peripheral vascular business.
MD+DI recently spoke with Pacyna to learn more about Reprieve Cardiovascular. The Q&A below has been edited for length and clarity.
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MD+DI: Are you looking to eventually tackle unmet needs within heart failure more broadly? Will the Reprieve System be the first of many products?
Pacyna: There is ample opportunity to improve heart failure overall, right? You’ve got the chronic care and there’s a lot of different angles to that, but you also have this substantial need for the acute heart failure patients that show up to the hospital volume overloaded, shortness of breath, and they need to get that excess fluid off. So, we felt like the best place for us to start was to address that acute need. We aren't changing the underlying disease of heart failure, but we are alleviating those acute symptoms.
MD+DI: What was the genesis of the Reprieve System?
Pacyna: The genesis of the idea is that these acute patients take up a substantial amount of healthcare dollars because they’re the single largest admission reason for Medicare patients in the U.S. So, there’s a lot of these patients showing up and on average, they’re in the hospital over 5 days, so as you can appreciate, that's a significant burden on the system. And that was the opportunity that we saw is that there was a way to more aggressively get all that fluid off, while at the same time making sure that you're mindful of the potential injuries to the kidney.
The company that Reprieve spun out of was a company called RenalGuard in Boston. And RenalGuard had a product in clinical program designed to address acute kidney injury by providing saline to moderate the effects on the kidney.
That’s really what’s happening in acute heart failure. The kidney is the organ that basically moderates all the fluid within the body and so you take a diuretic today and that forces the kidney to produce urine and the kidney doesn't really love that, as you can appreciate, and it adapts to the doses. And this is why it's so hard to get the fluid off is because the kidney doesn't necessarily give that fluid up. So, by giving a little bit of fluid back, you can moderate some of those signals to the kidney and moderate the potentially harmful effects of diuretics on the kidney. And it allows you to work with the kidney longer to get more fluid off these patients.
MD+DI: Where does your technology come in with the intelligent aspect?
Pacyna: We say it's a personalized and intelligent system to do this. Diuretics have been the foundation of treatment for 60 years, and what's interesting about diuretics is they’re a threshold drug. So, the level that you need, the level that I need, the level that Julia needs is all different. Every one of us. So, you have to get over a certain threshold for you to have a robust response and to produce a lot of urine. Right now, physicians don't know what that threshold is for each patient and so they go based on rules of thumb that if the patient is on X dose at home maybe they go X times 1.5 and they start there. ... But they don't have perfect information, so they'll start them on a dose in the morning, they'll check back either that afternoon or the next day to see if it worked and it didn't work well enough, they'll up the dose. That's why it takes so long to find the appropriate dose that those patients need.
What we do is we have a dose finding algorithm because we're watching real time urine production as a signal for us to know when we've gotten to a dose that is going to be impactful for that individual. We’re really personalizing the dose and we can do that within the first hour versus what oftentimes today in the healthcare system can take a couple days to find.
MD+DI: Are there any other outputs or biometrics that you’re looking at for signals in addition to urine output?
Pacyna: The two main things that we look at is total urine output as well as the sodium content of the urine. Why is the sodium content important? Actually the core mechanism that the body uses to regulate fluid balance is how much sodium you have in your system. So, if you get rid of the sodium and if the kidney excretes sodium, the fluid will go with that. So, we really look at urine sodium content as well as total urine output as inputs into our system of how much fluid we're taking off and how those patients are going to do long term.
MD+DI: So, just to be clear, it sounds like this is not meant to replace diuretics but optimize them?
Pacyna: I think that’s very well said, that’s exactly what we’re doing.
MD+DI: Turning to the financing and the current environment for fundraising, what kind of feedback have you received from your investors? What about the company and the technology seem to get them the most excited what do they find most attractive about this investment opportunity?
Pacyna: It is a challenging environment, but I think if you're in the right space with a big unmet clinical need, that's what investors are always looking for. Acute heart failure remains one of those big unmet needs. From an individual funding standpoint, the fact that we're very close to going into a pivotal trial and there's real clinical data that they've been able to take a look at and understand and get a gauge of the risk that's left in the program was very helpful for us. ... We generated both in the U.S. through the FASTR pilot trial that we're currently enrolling in as well as work we've done outside the U.S. ... So, the combination of having good data, having a big market opportunity, and the right timing.
MD+DI: What timelines are you looking at for those trials?
Pacyna: We would anticipate receiving approval to start a pivotal trial in the back half of 2024.
MD+DI: Are you thinking about potential exit strategies down the road? Are you thinking about going public eventually, or maybe hoping to catch the eye of one of the strategics and get acquired?
Pacyna: I spent 16 years at Medtronic before Reprieve, and part of that time was in Medtronic’s mergers and acquisitions group. So, I have a pretty good sense for how a lot of the bigger organizations think through things. ... It's still way too early for us to understand where this is going to go. More importantly, I think if we build this organization and build the technology and try to build the marketplace that we will be doing that long term ... we're going to make the right decisions today and we're going to make the right decisions if a strategic were to become interested that they will be inheriting something that has been built the right way.
Is the SMART Trial a Game Changer for TAVR?
Analysts discuss the potential impact of a clinical trial that had Medtronic’s Evolut technology go head-to-head with Edward’s Sapien platform.
By Omar Ford
Edwards Lifesciences has had the lion’s share of the transcatheter aortic valve replacement (TAVR) market. This is partially because the Irvine, CA-based company pioneered the space and has had a much longer runway than its competitors.
But could results from a new clinical study begin to turn the tide in favor of one of Medtronic, one of Edwards’s chief rivals in the space?
Several medtech analysts weighed in on the?SMall?Annuli?Randomized?To Evolut or SAPIEN?(SMART) Trial?that was presented at the American College of Cardiology Annual Scientific Session this past weekend.
But first - in plain terms, the SMART trial showed Medtronic’s Evolut TAVR platform outperformed Edwards’s Sapien platform.
More specifically, one-year results of the SMART trial with small aortic annuli (SAA) demonstrated noninferior clinical outcomes and superior valve performance as measured by bioprosthetic valve dysfunction performance for the Evolut TAVR platform compared to the SAPIEN platform.
"SMART was launched to better understand how the two most commonly used TAVR systems perform in patients with small aortic annuli, and particularly in women who tend to have smaller heart valves," said?Nina Goodheart, senior vice president and president, of Structural Heart & Aortic, which is part of the Cardiovascular Portfolio at Medtronic. "We continue to develop evidence to better understand the benefits of our Evolut TAVR technology in all patients, including patient populations that are underrepresented, under-diagnosed and under-treated. The results from the SMART trial demonstrate these benefits in a large patient population and reinforce our commitment to driving health equity and engineering the best technology to solve unmet patient needs."
Digging into the Data
The trial randomized and treated 716 patients, 87% of which were women, across more than 80 sites worldwide. Eligible patients had a computed tomography aortic valve annulus area of ≤430 mm2?and suitable anatomy for transfemoral TAVR with both an Evolut PRO/PRO+/FX or a SAPIEN 3/3 Ultra valve.
Results demonstrated that the Evolut TAVR platform met both co-primary endpoints of clinical non-inferiority and hemodynamic superiority at one year.
In an emailed statement to MD+DI, Edwards wrote, “The 1-year outcomes reported in the Medtronic-led SMART study, which was not an FDA approved trial, do not reflect contemporary experience in clinical trials or real-world evidence with the Edwards SAPIEN 3 TAVR platform.?Data presented at TCT 2023 demonstrated excellent durability for both Medtronic and Edwards TAVR valves at 4 and 5 years which should be reassuring to patients and their physicians.”
Unleash the Analysts
Robbie Marcus, an analyst with JP Morgan, gave insight on whether this would move the needle for Medtronic’s TAVR efforts.
“While the headline reads positive for Medtronic, we don’t expect today’s results to shift clinical practice or TAVR share and could actually lead to a relief rally in Edwards shares, in our view,” Marcus wrote in a research note.
The biggest sticking point for most analysts was the rate of bioprosthetic valve dysfunction (BVD) that was reported being found in the Sapien valves.
Marie Thibault, an analyst with BTIG, noted that some of the trial results were a bit surprising. She also noted that she didn’t foresee a huge shift in market share because of the data.
“This was largely expected by investors, but we were surprised by the magnitude of statistically significant superiority related to bioprosthetic valve dysfunction (BVD),” Thibault wrote in a research note. “We think the SMART results will generate buzz and discussion but that large market share shifts are unlikely. We would expect that as with any trial results, any shifts are likely to be smaller and more gradual as doctors do their own diligence and centers consider their protocols.”
Margaret Andrew, an analyst with Willaim Blair characterized the SMART results as one of the more “controversial debates” of the ACC weekend.
“While the hemodynamics benefits in Evolut were largely as expected, the Sapien arm showed significantly higher rates of BVD than what we have seen historically in years of clinical data on the Sapien platform,” Andrew wrote. “However, we also heard clinician concern about the misuse of definitions in the trial such as deterioration defined above 20 mmHg and nearly 30% of Evolut valves being 29 mm (i.e., not “defined” as small annulus patients and therefore could have led to discrepancies). We believe this data will continue to raise questions among clinicians, as it has already this weekend, and may lead to limited share shifts in the coming quarters. That said, Edwards has remained the market leader and clinically supported performance in its Sapien platform, which we expect to continue.”
Danielle Antalffy, an analyst with UBS, wrote that the degree of disparity with the level of valve dysfunction was likely to raise questions.
“Still, the level of valve dysfunction with Edwards is "perplexing" as one physician hosted by Edwards noted, given the obvious point that if in fact Edwards's valves had such a high level of BVD, not only would Edwards not have been able to retain ~70% market share for the past decade but also the TAVR market wouldn't likely be the ~$5B global market that it is today. Because of this discrepancy vs. what seem to be real-world results and what's been shown in other clinical trials, we remain of the view that this trial won't meaningfully change practice.”
The Current TAVR Landscape
Edwards won FDA approval for the first generation of the Sapien valve in 2011.
Medtronic’s entry point into the TAVR market was through its acquisition of CoreValveabout 15 years ago.
Since the deal – other companies have populated the market. In 2019, Boston Scientific won a nod from FDA for its Lotus Edge device. However, the Marlborough, MA-based company retired its entire Lotus platform in 2020, citing complexities with the product delivery system.
Boston Scientific went on to focus on its Acurate neo2 TAVR system. Abbott Laboratories has developed the Navitor transcatheter aortic valve implantation system. The system won CE mark in 2021 and FDA approval in January of 2023.
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