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Johnson & Johnson MedTech Chair Ashley McEvoy announces resignation

Former Johnson & Johnson MedTech Worldwide Chair Ashley McEvoy [Photo courtesy of Johnson & Johnson]Johnson & Johnson (NYSE: JNJ) + MedTech Worldwide Chair Ashley McEvoy plans to leave the world’s second-largest medical device manufacturer, she and J&J said today.

After 27 years with J&J — starting in consumer products and rising to the position of EVP and head of the company’s medical devices group — McEvoy gave her notice on Friday “to pursue new opportunities,” she said today.

McEvoy will stay on into the company’s first quarter, which starts in January 2024.

Medical Design & Outsourcing: Ashley McEvoy joins J&J’s top-paid executives

New Brunswick, New Jersey-based J&J has already appointed Tim Schmid, most recently J&J MedTech Asia Pacific (APAC) company group chair, as a J&J EVP and J&J MedTech’s new worldwide chair.

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FDA clears DePuy Synthes TriLeap plating system for foot and ankle surgeries

The TriLeap lower extremity anatomic plating system [Image courtesy of DePuy Synthes]DePuy Synthes, the orthopedic device business of Johnson & Johnson (NYSE: JNJ) + , has won FDA 510(k) clearance for its TriLeap lower extremity anatomic plating system.

The company said it designed the TriLeap system to address the intricate needs of orthopedic surgeons and foot and ankle specialists.

As conditions like bunions become more prevalent —with Cleveland Clinic reporting that one in three U.S. residents are grappling with the disorder—elective foot surgeries are witnessing a surge. Plating systems like TriLeap play an important role in these surgeries, functioning as implants that stabilize the bones during procedures such as bunionectomies and osteotomies.

TriLeap offers a wide range of plate options tailored for various procedures and screw diameters, according to DePuy Synthes. Its instruments can be used during th…

FDA issues warning letter to J&J’s Abiomed for Impella heart pump problems

The Impella RP Flex with SmartAssist pump [Image from Abiomed]Abiomed, a Johnson & Johnson (NYSE: JNJ) + unit, has received an FDA warning letter related to its Class I recall of Impella heart pumps.

The agency wrote Abiomed up for failing to report problems with the heart pump and selling its Impella Connect System software and hardware without FDA authorization. The FDA issued the letter in September after inspecting Abiomed’s facility in Danvers, Massachusetts in March and April.

“We are working closely with the FDA to fully resolve the observations as quickly as possible,” Abiomed said in an emailed statement. “As we continue to integrate into Johnson & Johnson MedTech, we are implementing quality system process improvements related to the observations, and many of these corrective actions are already in process.”

“We are …

Click chemistry breakthroughs drive Shasqi and J&J cancer alliance

In June 2023, the click chemistry-focused startup Shasqi revealed a research pact with Johnson & Johnson Enterprise Innovation. More recently, the company announced that it had expanded the research alliance, furthering work on its intratumorally injected biopolymer, known as SQL70. The collaboration will also apply its clinically validated Click Activated Protodrugs Against Cancer (CAPAC) technology to the development of new cancer therapies through preclinical testing.

Inside the click chemistry Shasqi J&J alliance

Shasqi is working with an interventional oncology unit at J&J, which is aiming to take a holistic approach to cancer care that spans therapeutics and therapeutic approaches to meet unmet needs. “That completely matches with our view of the world,” said Dr. José M. Mejía Oneto, the founder and CEO of Shasqi.

The partnership with J&J will bolster research on Shasqi’s intratumorally injected biopolymer SQL70 but also support the …

J&J’s DePuy Synthes wins FDA clearance for TriAltis tech

The TriAltis Spine system. [Image courtesy of DePuy Synthes]Johnson & Johnson MedTech announced today that its DePuy Synthes unit won FDA 510(k) clearance for two TriAltis technologies.

The FDA cleared the company’s TriAltis Spine system and the TriAltis navigation-enabled instruments. TriAltis Spine is a next-generation posterior thoracolumbar pedicle screw system. It offers a comprehensive implant portfolio and advanced instrumentation for integration with enabling technology.

DePuy Synthes’ TriAltis navigation-enabled instruments include drills, taps and screwdrivers. These offer manual operation or power operation for navigated and non-navigated use.

The company said combining its implants with a digital ecosystem can address unmet clinical needs. Its TriAltis Spine system could help surgeons achieve more consistent outcomes in treating complex spine conditions, too. That includes degenerative tumor, trauma and deformity pathologies.

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Biosense Webster: Catheter ablation leads to lower heart failure risk in AFib patients

Johnson & Johnson’s Biosense Webster today announced data supporting the use of catheter ablation in AFib patients.

The study, funded by the Irvine, California-based company, looked at heart failure incidence risks in AFib patients. It compared the use of catheter ablation versus antiarrhythmic drugs (AAD). Looking at non-specific catheter claims information, it showed catheter ablation’s association with lower heart failure risks compared to AAD only.

Biosense Webster says that several clinical studies highlight catheter ablation as a safe and superior alternative to AAD when performed appropriately. However, the company says less than 5% of the eligible population receive the procedure.

The study used the 2014-2022 Optum Clinformatics database to identify adult patients with AFib who previously used AAD. It classified them into two cohorts: those treated with catheter ablation versus those who received an AAD. The study matched the grou…

Johnson & Johnson MedTech plans manufacturing facility in Costa Rica

Johnson & Johnson MedTech will build a 200,000-sf² manufacturing facility in Alajuela, Costa Rica, the medical device developer said today.

It’s the largest investment J&J MedTech has ever made outside the U.S., according to Procomer, the agency that promotes Costa Rican exports.

J&J MedTech — Johnson & Johnson’s medical device business — said the plant will manufacture products across its franchises, with an emphasis on heart rhythm solutions and orthopedics. The new plant will also have space for shared services and will assess and support demand for product across J&J MedTech’s portfolio, which includes DePuy Synthes, Biosense Webster, Cerenovus, Ethicon and Johnson & Johnson Vision.

Construction starts this year on the facility, which will add around 3,000 new jobs in the region over the next three to five years, the company said.

“Nearly 300 million patients are treated with Johnson & Johnson MedT…

How Biosense Webster aims to expand access to AFib care

Biosense Webster U.S. President Nikki Sidi [Image courtesy of Biosense Webster]

Electrophysiology is “an incredibly vibrant space,” said Nikki Sidi, but access remains a challenge.

Nikki Sidi, the U.S. president of Johnson & Johnson’s Biosense Webster, can look at her own company as one of those paving the way in electrophysiology (EP). Its recent milestones include multiple atrial fibrillation (AFib) mapping catheters, including ablation and mapping devices.

Sidi has worked across a number of businesses at J&J, including leading U.S. marketing for Biosense Webster. She took on the post of U.S. president at Biosense Webster in December 2022 after a stint with J&J Vision.

Her return to Biosense Webster — and her return to AFib treatments — has been nothing short of “amazing,“ she said in an interview. Biosense Webster competes in a market that also includes …

Pfizer beefs up while J&J slims to focus on oncology

Image by PDPics from Pixabay

Both Johnson & Johnson and Pfizer are gearing up to release third-quarter results. While J&J continues to display resilience with its diverse portfolio, Pfizer continues to face challenges with waning demand for its COVID-19 therapies.

To date, Pfizer’s stock is down by roughly a third so far this year, reflecting concerns over its ability to maintain the sky-high revenue levels driven by its COVID-19 portfolio. Also reflecting this trend is moderate volatility in its stock price

J&J, on the other hand, has seen a more modest dip in its stock price so far in 2023 — 8.82% to $162.47. Unlike Pfizer, J&J’s diverse portfolio, spanning consumer health, pharmaceuticals, and medical devices, provides it with a more balanced revenue stream. The company has also been active in addressing challenges, from legal issues to the loss of exclusivity for key drugs li…

Biosense Webster begins Omnypulse pulsed-field ablation trial

Johnson & Johnson’s Biosense Webster today announced the first cases with its investigational Omnypulse catheter as part of the Omny-IRE clinical trial.

The Omnypulse platform features the Omnypulse catheter and the Trupulse generator. Omny-IRE looks at the platform for mapping and treatment of symptomatic paroxysmal AFib during standard ablation procedures.

Dr. Dr. Mattias Duytschaever performed the first procedures at AZ Sint-Jan Hospital in Brugge, Belgium. Omny-IRE, a pivotal, prospective, multi-center, non-randomized trial looks set to enroll approximately 135 patients. Taking place in Europe and Canada, it will evaluate Omnypulse’s safety and effectiveness.

“In the cases I performed as part of the Omny-IRE trial, the contact force data from the Omnypulse catheter aided the initial map creation in the Carto 3 system, and the integrated PF Index module allowed me to correlate my ablation parameters with the lesion creation,” said Duyt…

These devices are the top targets of lawsuit-related advertisements

Surgical mesh products continue to drive medical device lawsuit spending. [Photo via Adobe Stock]

Spending on advertisements related to medical device lawsuits this year is on track to exceed last year’s tally.

That’s according to figures provided by Washington, D.C.-based X Ante, which uses data from ad intelligence firm Vivvix. X Ante supplies reports on medical device lawsuit ad spending to the Advanced Medical Technology Association (AdvaMed), which is calling for new federal regulations of mass tort advertising to protect device manufacturers from lawsuits bankrolled by third-party funders.

For the first half of 2023, $6.2 million worth of legal ads targeted five kinds of medical devices:

Pelvic mesh: $3.5 million Hernia mesh: $1.9 million CPAP machines: $532,000 Physiomesh: $262,000 Military earplugs: $54,000

Spending on the top five device categories totaled just under $11 mil…

Johnson & Johnson pharma rebrand highlights innovation as a pillar to reinforce trust

Global pharma and medical device giant Johnson & Johnson (J&J) has ditched its iconic cursive logo that dates back to the late 19th century, and rebranded its Janssen pharma division as Johnson & Johnson Innovative Medicine. The move underscores the company’s push to prioritize higher-margin prescription drugs. This strategic move comes amidst a backdrop of significant legal challenges the company has faced in recent years.

In the five-year period from 2018 to 2022, Johnson & Johnson was the most active defendant in medical device and pharmaceutical cases. In addition, before spinning off its consumer health division, the company was targeted in tens of thousands of lawsuits alleging J&J-branded talcum powder causes cancer. Earlier this year, a judge dismissed the company’s attempt to settle thousands of lawsuits through bankruptcy.

The chart below shows the number of cases filed against J&J-affiliated entities in the life sciences secto…