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Medical Device

Roche scores FDA breakthrough status for Alzheimer’s blood test

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Dive Brief:

Roche has received the Food and Drug Administration’s breakthrough device designation for a blood test to support earlier diagnosis of Alzheimer’s disease, the Swiss drug and diagnostics company said Thursday.
The test, once approved, could help healthcare providers identify whether amyloid pathology, a marker for Alzheimer’s disease, is present or absent in patients.
The Elecsys pTau217 plasma biomarker test is being developed as part of an ongoing partnership between Roche and Eli Lilly. 

Dive Insight:
The biomarker pTau217 is a fragment of the protein tau that has shown the ability in research to distinguish Alzheimer’s disease from other neurodegenerative disorders.
No FDA-authorized pTau217 or blood tests exist for Alzheimer’s detection.
New and emerging Alzheimer’s therapies aimed at slowing cognitive decline in the earlier stages of the disease call for confirmation of amyloid pathology, yet the only methods currently cleared for that task are cerebrospinal fluid (CSF) tests and amyloid positron emission tomography, or PET, scan imaging, according to Roche.
Some 75% of dementia cases remain undiagnosed, even as the incidence of Alzheimer’s disease is growing worldwide, Roche said.
The company said its blood test could help broaden and speed access to diagnosis and appropriate care, including participation in clinical trials and approved disease-modifying therapies.
 “We believe pTau217 is going to be crucial in the diagnosis of Alzheimer’s disease. We plan to leverage our installed base of diagnostic systems, which is the largest in the world, to ensure we are able to create access to this test for those who need it the most,” Matt Sause, CEO of Roche Diagnostics, said in a statement.
A positive Elecsys pTau217 result indicates a high likelihood of having a positive amyloid PET/CSF result, while a negative Elecsys pTau217 result indicates a high likelihood of having a negative amyloid PET/CSF result, the company said.
Roche already has CSF assays on the market.
The breakthrough designation allows Roche to work closely with the FDA, get direct feedback through the premarket review phase and receive prioritized review of regulatory submissions for the device.

Cook Medical wins contract to supply implants to US Defense Department

Dive Brief:

Cook Medical has received a contract to supply implantable devices to hospitals run by the U.S. Department of Defense (DoD), the company said Thursday.
The one-year contract, which has four one-year extension options, covers Cook’s Zilver PTX drug-eluting peripheral stent, Zenith aortic endografts and other implantable devices. 
Cook said the contract will streamline procurement to enable the DoD to quickly treat military service members, citing another contract it won in October 2023 as evidence it can improve the supply chain.

Dive Insight:
Through the new contract, Cook will make devices available to all DoD hospitals in the U.S. Ross Harvey, Cook’s vice president of supply chain, said in a statement that supply will expand to cover all overseas hospitals “in the coming months.” The contract takes advantage of Cook’s global network to cut the time it takes to get devices to physicians in the DoD network, Harvey added. 
The DoD published its most recent notice about a contract awarded to Cook in March. The original solicitation from the DoD covered drug-eluting stents and other cardiovascular products. The DoD listed the total value of the contract, including all options, at $13.7 million.
Cook’s statement follows an October 2023 release about its third contract with the U.S. Department of Veterans Affairs (VA). Like the DoD deal, the VA contracts cover the Zilver PTX stent and Zenith aortic endografts. Cook is also supplying the VA with its Biodesign line of biologics products, which are used in tissue repair. 
The company framed the contracts in the context of its work to provide a simplified procurement process that enables customers to treat more patients faster.
Cook’s successes with the VA and DoD have come in a period of change at the company, which has laid off 500 people in response to a “significant” shift in its operating environment and sold units to CooperCompanies and C2Dx over the past year.

Abbott’s Nadim Geloo on Triclip’s US launch, Edwards competition

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Abbott secured Food and Drug Administration approval last week for Triclip, a device to give patients too frail for open-heart surgery a less-invasive option for repairing a leaky tricuspid valve. The technology is based on Abbott’s successful Mitraclip repair device for the mitral valve but designed for the tricuspid.
Triclip is now the second transcatheter device approved in the U.S. to treat patients with tricuspid valve regurgitation, after Edwards Lifesciences in February said it gained the FDA’s nod for a valve replacement system called Evoque. The two companies took different treatment approaches: Edwards developed a replacement valve, while Abbott contends that repair is a better option.

MedTech Dive spoke with Abbott’s Nadim Geloo, senior medical director of the structural heart division and an interventional cardiologist, to learn more about the U.S. launch of Triclip, how the device differs from Edwards’ tricuspid replacement system, and what the company has planned in the transcatheter aortic valve market.
This interview has been edited for length and clarity. 
MEDTECH DIVE: What medical condition is Triclip designed to treat?
NADIM GELOO: Tricuspid regurgitation is the name of the disease, and it’s a debilitating disease. It’s caused by a valve that rests between the two chambers in the right side of the heart. This is designed as a one-way valve, and it’s supposed to allow blood to flow from the atrium into the ventricle, which then sends it up to the lungs. Unfortunately, with tricuspid regurgitation, the flaps, or leaflets, of the valve, don’t meet correctly; they don’t create a tight seal.
When the heart squeezes blood up towards the lungs, it actually leaks back into the right atrium because of this defect, and unfortunately, this ends up causing a lot of fluid buildup for patients in their body, in their legs, in their abdomen. It causes them to feel generally very weak and tired. Some people are not able to lay comfortably because of the abdominal discomfort, and there is a long list of other effects that just reduces the quality of life for these patients.
I’ll just speak as a physician who’s still practicing and actually did these types of procedures for many years. When I saw these patients in the office, they were so debilitated. Surgeons oftentimes did not want to operate on these patients. You were essentially treating it with medical therapy, which for the most part amounts to diuretic therapy. Diuretics can be very uncomfortable for patients to take. For many patients, they just don’t do it. They’re living this existence where they can’t enjoy life.

How many patients could benefit from this treatment?
In the United States, up to 1.6 million are estimated to have clinically significant tricuspid valve regurgitation, and across the world, that number goes up to approximately 70 million. European physicians have deployed thousands of these clips in patients, and we’ve noticed a significant outcomes benefit, with patients feeling significantly better with a measurable improvement in their quality of life.
What is Abbott’s plan for rolling out the device in the U.S.?
The most important part of any device launch is ensuring the doctors are thoroughly trained on conducting the procedure and selecting the right patients. We will roll out the device in the U.S. at centers that were involved in the clinical trials because those are the most experienced centers, and then we’ll have a tiered approach thereafter.
We want to ensure that this is a safe procedure for the patient. It was demonstrated in the clinical trial that 98% of patients had no adverse effects from the procedure at 30 days. Of course, the outcomes from the trial were also fantastic, with 50% of the people who received Triclip experiencing a more than 15-point improvement in the KCCQ [Kansas City Cardiomyopathy Questionnaire] quality of life score. We want to achieve these results straight out of the gate, and we’re going to be very careful and deliberate in the way that we roll it out. That said, it’s going to be something that we want patients to have access to much sooner than later.

Abbott’s Triclip device was recently approved by the FDA, following a nod for Edward Lifesciences’ rival Evoque system.
Permission granted by Abbott

How does Triclip compare to Edwards’ Evoque tricuspid valve replacement device?
We feel that tricuspid valve repair is the better option for the majority of patients, and that’s based on a lot of history. If you go back to the surgical literature, before any catheter-based devices were available and surgeons were doing surgery to either replace or repair the valve, mostly in the mitral valve population, the vast majority choose to repair the valve because they feel results from repair are better for patients.
If you translate that to the catheter-based space, we feel the same. In the mitral and tricuspid, we feel that repair is the better option for patients. It’s less invasive. You don’t have a large valve there, which sometimes may require more aggressive anticoagulation early on.
But I think the important thing to know is the options are there for patients, and that’s who wins.
What has been the response to Triclip in the countries where it has been available for the past couple of years?
We’ve talked to a lot of physicians about how their patients do, and we hear great anecdotal stories about that, but more importantly, we have data from registries, particularly a large registry called the Bright registry. We saw great results, as we saw in the Triluminate trial, with patients feeling significantly better and having very few bad outcomes or adverse effects. While this is a new device to the United States, regarding approval, it has been an approved device overseas since 2020, and has demonstrated fantastic outcomes.
What does Abbott have planned in the aortic valve market?
We have a device that’s approved, called the Navitor, available both in Europe, and currently in the United States for patients who have an increased risk for heart surgery. We are conducting trials to achieve, pending trial completion, approval for all risk patients in the United States.
It’s a self-expanding valve, which means a balloon is not required to deploy it. Then it has tissue leaflets that open and close, and it replaces the aortic valve. You deliver it with a catheter from the femoral artery in the leg, and patients have the procedure and are often up and walking the same day.

We have launched a clinical trial, called the Envision trial, in the United States that hopefully will lead to approval for all risk patients — low, intermediate and high risk — and we’re confident that this valve is the right valve for patients.

Osso VR brings surgery training app to Apple Vision Pro

Dive Brief:

Osso VR has launched a medical training app for the Apple Vision Pro mixed-reality headset.
The app simulates the operating room to help healthcare professionals and patients preparing for surgery learn about the key steps in two procedures, carpal tunnel release and total knee replacement. The company announced the release on Thursday.
Osso VR’s launch follows Siemens Healthineers’ introduction of an Apple Vision Pro app that allows people to view interactive holograms of the human body through the headset.

Dive Insight:
Osso VR, which recently said it will lay off 67 people, has developed a virtual reality surgical platform for training and assessing physicians. The company has created software for Quest headsets from Meta, Facebook’s parent company, and taken advantage of technological advancements of that platform such as hand-tracking capabilities that eliminate the need for controllers. 
The Apple headset also has hand-tracking capabilities, as well as features that set the device, which is more expensive than Meta’s products, apart from the competition. Justin Barad, co-founder and chief strategy officer at Osso VR, explained some of the benefits of the Apple technology in a statement. 
“Apple Vision Pro unlocks new opportunities to scale spatial computing in healthcare with groundbreaking display quality and virtually lag-free learning experience, helping solve important challenges to education in healthcare,” said Barad, who stepped down as CEO in February.
Osso VR has not yet brought all of its content to the Apple device. The company provides more than 25 orthopedic training modules through Osso Academy, allowing people to practice procedures such as total shoulder replacement and anterior hip surgeries using virtual reality headsets. Meanwhile, Osso VR’s Apple app allows users to practice two procedures. 
The company plans to cut 30 people with titles related to art and illustration, as part of the elimination of 67 positions at its headquarters in San Francisco. Osso VR CEO Greg Born said the changes were intended to “enhance our operational efficiency and better align our resources with the market’s demands.”

Steris to sell dental segment for $787.5M

Dive Brief:

Steris has agreed to sell its dental business to investment firm Peak Rock Capital for $787.5 million in cash, the companies said on Thursday.
The sale will allow Steris to focus on its core markets of healthcare, pharma and medtech, CEO Dan Carestio said in a statement. The Mentor, Ohio-based company provides sterilizers and washers, surgical tables and other equipment.
Steris decided to divest the dental segment “after a thorough review of strategic alternatives,” Carestio said. The business reported $407 million in revenue and $86 million in operating income during the 12-month period ending Dec. 31, 2023.

Dive Insight:
Steris acquired the dental business in 2021 when it bought Cantel for $4.6 billion. The purchase was expected to complement Steris’ existing business, adding infection control products for endoscopy and providing an entry into the dental market.
Now, the company is looking to sell the segment. Peak Rock Capital agreed to pay an additional $12.5 million to Steris if the dental business achieves certain revenue targets in fiscal year 2025. 
“We are confident this business will do well with the investment and support of Peak Rock Capital,” Carestio said.
The planned sale comes after a few challenging quarters for the dental segment. Dental revenues declined by 6% on a constant currency basis in the quarter ending Dec. 31 because of “reduced orders from a large customer due to a temporary disruption of their operations as a result of a cybersecurity incident,” Carestio said. Without the cybersecurity incident, revenue for the segment would have been flat year over year.
On a November earnings call, the CEO said the economic downturn has affected people’s ability to spend money on elective dental procedures, a trend that is rippling through the entire dental industry. 
Steris expects the sale to close in the first quarter of its 2025 fiscal year, subject to regulatory review and other customer closing conditions. The company expects the sale to reduce its interest expenses by about 35 cents per diluted share on a full-year run rate basis. 
Steris will use most of the proceeds to repay debt.

FDA expands import alert to block all plastic syringes from Chinese manufacturer

Dive Brief:

The Food and Drug Administration published an expanded import alert Wednesday to stop all plastic syringes made by a Chinese manufacturer from entering the U.S.
On March 28, the FDA issued an import alert to stop the company, Jiangsu Shenli Medical Production, from importing only unauthorized plastic syringes into the U.S. The agency expanded the blockade this week to all plastic syringe models because the company failed to meet device quality system requirements.
The expanded import alert is the latest in a series of FDA actions in response to reports that plastic syringes made in China can leak, break and otherwise suffer quality problems.

Dive Insight:
The FDA imposes import alerts to allow it to detain products without a physical examination. The agency uses the power when an inspection has found a company is breaching good manufacturing practices or if a foreign regulator has shared details of similar problems with the FDA.
The agency sent a warning letter to Jiangsu Shenli in March after inspecting Medline Industries, a company that distributes its plastic syringes in the U.S. FDA inspectors accused Medline of providing Jiangsu Shenli devices that have substantially different technological characteristics than the device authorized in the Chinese company’s 510(k) clearance. 
At that time, the FDA advised healthcare providers to immediately move away from using unauthorized plastic syringes produced by Jiangsu Shenli unless absolutely necessary. The company’s only authorized device is a 5 mL luer lock syringe. Later, the FDA issued an import alert against Jiangsu Shenli but limited the scope of the ban to the unauthorized devices it targeted in the warning letter. 
On Wednesday, the FDA expanded its import alert and recommendation against using Jiangsu Shenli devices to cover all the company’s plastic syringes. The agency said it expanded the alert “for not meeting device quality system requirements.”
The update means the FDA now has import alerts in place against all the products from both Chinese companies targeted in the investigation to date. The FDA issued an import alert against the other plastic syringe manufacturer, Jiangsu Caina Medical, on April 3.

IDC enhances the Reach Surgical Ultrasonic Shears with Improved Ergonomics

IDC enhances the Reach Surgical Ultrasonic Shears with Improved Ergonomics     Press Release: MTI Staff was not involved in writing this content April 8, 2024 / Berkshire, England – The leading international brand’s ultrasonic shears had once dominated the domestic market and played a pivotal role in introducing, promoting, and educating the market about this product category. A …

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Interest Rates, Labor and Cybercrime Keep Pressure on Healthcare

Interest Rates, Labor and Cybercrime Keep Pressure on Healthcare     The various pressures that have been a drag on the healthcare sector—many in place before the disruptions stemming from the COVID-19 pandemic—may relent to some extent this year. But it’s still no time for organizations to let down their guard against the risks. The good …

Interest Rates, Labor and Cybercrime Keep Pressure on Healthcare Read More »

Federal Court Enters Consent Decree Against Philips Respironics Following Recall of CPAP Machines

Federal Court Enters Consent Decree Against Philips Respironics Following Recall of CPAP Machines     On April 9, the U.S. District Court for the Western District of Pennsylvania entered a consent decree of permanent injunction against Philips RS North America (“Philips Respironics”), Respironics California, Philips Holding USA, and Roy Jakobs, CEO of Royal Philips, along with …

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Illumina CFO steps down amid executive shakeup

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Joydeep Goswami is leaving Illumina 14 months after becoming its permanent CFO, the company said Tuesday.
Ankur Dhingra, who worked with Illumina CEO Jacob Thaysen at Agilent Technologies, is joining the genome sequencing company to replace Goswami. Illumina also disclosed the appointment of Jakob Wedel as chief strategy and corporate development officer.
Evercore ISI analysts said the prior working relationship between Dhingra and Thaysen should be a positive, noting the fact that the CEO is “making these changes is a sign of him getting comfortable with the business and pushing the organization to the next level.”

Dive Insight:
Goswami joined Illumina in 2019 to work as chief strategy and corporate development officer, the role now held by Wedel. In 2022, Sam Samad stepped down as Illumina CFO after more than five years to take up the same position at Quest Diagnostics. Goswami initially took on the CFO role on an interim basis before Illumina gave him the position on a permanent basis in February 2023.
Now, Illumina’s financial team is undergoing another shakeup with Dhingra becoming the third person to hold the CFO title in as many years. Dhingra left Summit Therapeutics last week, walking away from the biotech after almost two years as CFO.
Goswami will stay on with Illumina in an advisory role through June 30.
Dhingra spent 18 years at Agilent earlier in his career, rising to vice president of investor relations before leaving the company in 2021. His time at Agilent overlapped with the decade that Thaysen spent at the company. Thaysen joined Illumina in September.
The new CFO’s compensation package includes a $650,000 base salary, $500,000 one-time cash payment and one-time grant of equity awards in aggregate of $3.5 million, according to a filing with the U.S. Securities and Exchange Commission.
Evercore analysts cited the existing relationship between the executives as a positive in a note to investors. 
“It is not overtly surprising to see such CEO changes during transition periods. Keep in mind Ankur worked with Jacob at Agilent and this working relationship should be a positive,” the analysts said.
The first step for Thaysen was to minimize disruption and get clarity on the Grail separation, the analysts added. In step two, Evercore expects the CEO to focus on turning around Illumina’s core business. Illumina reaffirmed the guidance it shared in February, when the company forecast that tighter funding and budget pressures would result in flat full-year sales. 
Wedel will support step two in his new role as chief strategy and corporate development officer, a post that makes him responsible for strategic planning, partnerships and acquisitions. The executive joined Illumina in November 2023 as CEO chief of staff.