Johnson & Johnson MedTech Archives - Page 4 of 7

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 …

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…

Johnson & Johnson drops 136-year old logo and renames Janssen

Johnson & Johnson is replacing its iconic cursive logo with a new look. [Logos courtesy of J&J]

Johnson & Johnson has rebranded with a new logo and a new name for its Janssen pharmaceutical business one year after renaming its medical device business — and just weeks after spinning off its consumer health business.

New Brunswick, New Jersey–based Johnson & Johnson (NYSE: JNJ) has replaced its 136-year-old logo — based on the signature of co-founder James Wood Johnson — with a “more modern logo and brighter red, keeping the iconic ampersand,” J&J CEO Joaquin Duato said today in a post on LinkedIn. The change is meant to call attention to J&J’s focus on innovative medicine and medtech, he said.

The Janssen Pharmaceutical Cos. of Johnson & Johnson, meanwhile, is from now on going as Johnson & Johnson Innovative Medicine, “leading where medicine is goin…

What are the largest medical device companies?

Medtronic, Johnson & Johnson MedTech and Siemens Healthineers again lead the Medtech Big 100 list of largest medical device companies.

However, there is so much more to Medical Design & Outsourcing and MassDevice‘s 2023 edition of the Medtech Big 100 report. We pulled thousands of data points to provide information on annual revenue, R&D spending, headcount, CEOs and key leaders, headquarters locations and descriptions of each of the 100 largest medical device companies.

Senior Editor Danielle Kirsh’s analysis shows that even as the largest medtech companies engaged in layoffs over the past year, they also made a bet on innovation to boost future growth: R&D spending increased nearly 13% to $26.4 billion. (Read the full story on MDO.)

In addition, the full Medtech Big 100 list includes already completed medtech company spinoffs such as Embecta , GE HealthCare and ZimVie.

Read the full Medtech Big 100 report to find out …

Johnson & Johnson finalizes Kenvue spilt-off

Johnson & Johnson (NYSE: JNJ) + announced today that it completed the separation of its Kenvue consumer health business.

Kenvue completed its IPO in May 2023. Johnson & Johnson last month announced its intention to split off at least 80.1% of the shares of Kenvue. The separation enables the company to sharpen its focus on its MedTech and Pharmaceutical businesses.

Today’s announcement confirmed the final results of an exchange offer to shareholders, which expired on Aug. 18. J&J accepted nearly 191 million shares of its common stock in exchange for more than 1.5 billion shares of Kenvue common stock.

According to a news release, the oversubscribed exchange offer means J&J only accepted a portion of shares validly tendered. Shareholders who owned fewer than 100 shares and validly tendered all shares were not subject to proration. J&J retains approximately 9.5% of the outstanding shares o…

FDA deems latest Abiomed Impella recall Class I

The Impella RP Flex with SmartAssist. [Image from Abiomed]Abiomed, a Johnson & Johnson (NYSE: JNJ) + unit, issued another recall for some of its Impella heart pumps.

This marks the third safety notice regarding the heart pumps in as many months. In June, the company recalled 466 Impella 5.5 with SmartAssist devices. Abiomed initiated that recall after receiving complaints relating to purge fluid leaking from the purge sidearm of the pump. Last month, the company issued another Impella recall, this time for potential contact with transcatheter aortic valve replacement (TAVR) implants.

The FDA shared a notice labeling the recall as Class I, the most serious kind. It impacts 65 of Abiomed’s Impella RP Flex with SmartAssist devices in the U.S. It’s a voluntary correction — not a product removal.

Abiomed distributed affected devices between Nov. 1, 2022, and now, initiating the recall on June 29, 2023. …

Device design and development tips for the future of stroke care

Michael Gilvarry is the GM of Cerenovus in Galway, Ireland. [Photo courtesy of Johnson & Johnson MedTech]

Simplicity and speed will be the most important innovations for medical devices that treat strokes in the years ahead.

That’s according to Michael Gilvarry, GM of Johnson & Johnson MedTech’s Cerenovus business. While he declined to divulge his neurovascular unit’s plans for future products, he offered advice for other device developers in a field where every minute counts.

A large vessel ischemic stroke can destroy more than 2 million brain neurons per minute before treatment restores oxygenated blood flow. A study quantifying the “time is brain” stroke mantra found that hourly neuron loss is equivalent to more than three years of normal aging.

“The drive for simplicity in stroke is very, very strong,” Gilvarry said in a Medical Design & Ou…

J&J used RWE for an expanded indication — and you can, too

Two J&J MedTech leaders shared advice to help medical device developers use real-world evidence (RWE) in FDA submissions.

J&J MedTech’s Biosense Webster ThermoCool SmartTouch [Image courtesy of J&J MedTech]

Real-world evidence (RWE) took a big step forward recently when the FDA approved an expanded indication for a Johnson & Johnson MedTech ablation catheter.

For the first time, the federal medical device safety regulator approved a label expansion based on RWE from a retrospective study of health records documenting off-label use by physicians.

“The clinical evidence used to support the expansion of indications was based solely on an analysis of a dataset comprised of electronic health records from two hospital systems,” the agency said. “The FDA worked closely with the study sponsor to ensure that the RWE resulting from the analysis was both relevant and reliable…

Find solutions to your most demanding medtech problem at DeviceTalks West

Add some essentials to your toolbox with engineering expertise from our upcoming show in California.

Intuitive President Dave Rosa will give a keynote interview at DeviceTalks West 2023. [Photo courtesy of Intuitive]

In the medical device industry, stubborn problems can cost millions in development expenses and delay the introduction of new life-saving tools and technologies.

That’s why we build our DeviceTalks meetings as a forum where successful medical device engineers, manufacturers and market-builders can share their best practices, providing solutions that help clear hurdles, speed product development and potentially save lives.

DeviceTalks attendees leave our meeting with notebooks full of critical advice and pockets full of business cards. We’ll help fill both at DeviceTalks West, which takes place Oct. 18-19 at the Santa Clara Convention Center in California. You can view the full agenda on our…