Johnson & Johnson MedTech Archives - Page 5 of 7

FDA approves multiple AFib ablation devices from Biosense Webster

The Thermocool SmartTouch SF ablation catheter [Image courtesy of J&J’s Biosense Webster]Johnson & Johnson’s (NYSE: JNJ) + Biosense Webster announced today that the FDA approved several products in its cardiac ablation portfolio for zero fluoroscopy workflow.

Products that received approval include the ThermoCool SmartTouch SF catheter, the most commonly used ablation catheter for radiofrequency ablation. The portfolio’s approved products also include the standard ThermoCool SmartTouch and Carto Vizigo bi-directional guiding sheath. Biosense Webster’s Pentaray Nav Eco high-density mapping catheter, DecaNav mapping catheters and the Webster CS catheter also picked up approval.

Updated workflows indicate that direct imaging guidance, like ultrasound, can offer an alternative to fluoroscopy.

“The label change approved by the FDA underscores that the Biosense Webster integrated eco…

Johnson & Johnson looks to split off Kenvue, focus on MedTech and Pharma

Johnson & Johnson (NYSE: JNJ) + today announced its intention to split off at least 80.1% of the shares of Kenvue.

The New Brunswick, New Jersey-based company plans for the split of its former consumer health business to take place through an exchange offer. Kenvue completed its IPO in May 2023.

Through the planned exchange offer, Johnson & Johnson shareholders can exchange all, some or none of their stock for Kenvue common stock. The company expects the exchange offer to be tax-free for U.S. federal income tax purposes. In connection with the planned split-off, J&J received a waiver of a 180-day lock-up. This relates to shares of Kenvue common stock held by the company from the joint lead book-running managers of the IPO.

“The separation of Kenvue further sharpens Johnson & Johnson’s focus on transformational innovation specifically in Pharmaceutical and MedTech,” said Joaquin Duato, chair and C…

J&J’s Biosense Webster launches AFib mapping catheter

The Optrell mapping cathter. [Image courtesy of Biosense Webster]Johnson & Johnson’s (NYSE: JNJ) + Biosense Webster announced today that it launched the Optrell mapping catheter with TrueRef technology.

Irvine, California-based Biosense Webster designed Optrell as a high-density diagnostic catheter powered by its Carto 3 system. It features small electrodes arranged in a fixed array formation. These provide high-definition electrophysiological mapping of complex cardiac arrhythmia cases.

Optrell with TrueRef maps cases like persistent AFib, redo AFib ablation, atrial tachycardia and ventricular tachycardia.

Biosense Webster received FDA 510(k) clearance for Optrell with TrueRef in 2022. In addition to this U.S. launch, it plans to make the technology available in Japan later this year.

Get the full story at our sister site, Medical Tubing & Extrusion.

Johnson & Johnson posts Street-beating Q2, raises guidance

Johnson & Johnson (NYSE: JNJ) + shares are up today on second-quarter results that topped the consensus forecast.

Shares of JNJ rose more than 5% to $159.50 apiece in morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was up slightly.

The New Brunswick, New Jersey-based company posted profits of $5.1 billion. That amounts to $1.96 per share on sales of $25.5 billion for the three months ended June 30, 2023. The company posted a 6.9% bottom-line gain on sales growth of 6.3%.

Adjusted to exclude one-time items, earnings per share totaled $2.80. That landed 18¢ ahead of Wall Street, where analysts projected sales of $24.6 billion.

Johnson & Johnson MedTech posted revenues of $7.9 billion, marking a 12.9% improvement year over year. Growth drivers for the segment included electrophysiology products in intervention…

J&J’s Abiomed recalls Impella again — this time it’s TAVR-related

This illustration shows the Impella 5.5 with SmartAssist placed in the heart. [Image courtesy of Abiomed]Johnson & Johnson’s (NYSE: JNJ) + Abiomed unit issued another recall for some of its Impella heart pumps.

FDA communications dated July 14 confirmed the second recall in a month for certain Impella products. 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.

The latest medical device correction notice sent by Abiomed includes potential issues with six Impella models. It covers the Impella 2.5, Impella 5.0, Impella 5.5 with Smart Assist, Impella LD, Impella CP and Impella CP with Smart Assist. The issue relates to potential contact with transcatheter aortic valve replacement (TAVR) implants.

This marks the first communication regarding the issue in the U.S., a…

J&J’s Ethicon has a serious Megadyne electrode recall due to potential burns in electrosurgery

The Megadyne Mega Soft and Mega 2000 electrodes manufactured by J&J’s Ethicon. [Images from the FDA]The FDA labeled a recall of Megadyne electrode products manufactured by Johnson & Johnson’s Ethicon Class I, the most serious kind.

Recalled products include a number of Megadyne Mega Soft electrodes and the Mega 2000 patient return electrode. Ethicon paid an undisclosed amount to acquire Megadyne Medical Products in 2017 after several years of collaboration.

According to an FDA notice, the recall affects 21,200 devices in the U.S. The firm distributed those devices between March 11, 2021, and May 9, 2023, before initiating the recall on June 1, 2023.

Both the Mega 2000 and Mega Soft reusable patient return electrodes are soft pads used during electrosurgery. During these procedures, an electric current heats or cuts tissue or stops bleeding. An electrosurgical generator creates the electric current and a small, pen-like attachment deliver…

They said it at DeviceTalks Boston 2023

Medical device industry leaders from Boston Scientific, Abbott, ZimVie, Medtronic, Stryker and more met at DeviceTalks Boston to share lessons learned and their perspectives on industry trends, device design and medtech innovation.

BD Chair, CEO and President Tom Polen (right) at DeviceTalks Boston with DeviceTalks Editorial Director Tom Salemi [Photo by Jeff Pinette for Medical Design & Outsourcing]

Bidding farewell to DeviceTalks Boston 2023, we look back at an exceptional two-day medical device conference teeming with insights from over 100 top industry leaders.

These experts unfolded many complexities of the medtech industry in more than 35 sessions, walking attendees from the medical device product development continuum through the latest medical innovations and strategies to tackle regulatory challenges, prototyping, manufacturing, product launches and more.

Between the high-profile keynote int…

Data supports Biosense Webster RF ablation for treating AFib

The QDOT Micro catheter. [Image from Biosense Webster/Johnson & Johnson MedTech]Johnson & Johnson MedTech’s Biosense Webster today announced data from a study of its QDOT Micro catheter for treating AFib.

JACC: Clinical Electrophysiology published data from the Q-FFICIENCY study evaluating QDOT Micro’s safety and 12-month effectiveness. The study observed use of the catheter in paroxysmal AFib ablation using a combination of high-power and conventional modes. QDOT features a very high-power, short-duration QMODE+ mode and a conventional-power, temperature-controlled QMODE setting.

Irvine, California-based Biosense Webster conducted its prospective, multicenter study across 22 U.S. centers. It evaluated 166 patients with drug-refractory, symptomatic paroxysmal AFib. The study demonstrated that the use of QDOT’s QMODE+ setting, alone or inc combination with QMODE, improved procedural efficiency. It also showed enhanced 12-month effectivenes…

Medtronic and Johnson & Johnson reportedly consider Shockwave acquisition

The Shockwave Intravascular Lithotripsy (IVL) System uses pressure waves to break up calcification restricting blood flow. [Image from Shockwave Medical]Medtronic (NYSE:MDT) and Johnson & Johnson (NYSE:JNJ) are interested in acquiring Shockwave Medical (Nasdaq:SWAV), according to a StreetInsider.com report citing an unnamed source.

The financial news website did not say how the source knows the information or why they are not being identified by name.

“We don’t comment on rumors or speculation,” Medtronic spokesperson Erika Winkels said today.

Johnson & Johnson and Shockwave have not yet responded to requests for comment, but we’ll update this post if they do.

Bloomberg last month said that Boston Scientific (NYSE:BSX) was also eying Shockwave. The Bloomberg report cited “people with knowledge of the matter” — who asked not to be named due to the privacy of the talks.

There’s no doubt Shockwave is hot.…

Johnson & Johnson MedTech: ‘Stay tuned’ for Ottava next-gen surgical robot

Martin Buehler.

It’s been about two and a half years since Johnson & Johnson (NYSE:JNJ) unveiled its plans for a next-generation surgical robot.

At the time, the six-armed “Ottava” system generated a lot of buzz. Johnson & Johnson shared details on the surgical robotic platform set to offer unrivaled flexibility and control compared to the rest of the market. It features six arms to provide more control and flexibility in surgery, while those arms will be integrated into the operating table.

The company said its platform has a zero-footprint design to enable patient access, increase space in the operating room and improve workflow.

Over the past 30 months, though, the company remained tight-lipped over developments with the platform. In October 2021, J&J pushed back the platform’s development timeline by about two years due to multiple factors. It initially expected was to begin the verification and validation processes for …

Johnson & Johnson MedTech’s leader is AdvaMed’s new chair

Johnson & Johnson MedTech EVP and Worldwide Chair Ashley McEvoy [Photo courtesy of Johnson & Johnson]AdvaMed announced today that it has named Ashley McEvoy, EVP of MedTech at Johnson & Johnson, as its new chair.

The group’s board of directors unanimously elected McEvoy as its chair during its quarterly meeting yesterday. She is the first woman to serve as chair at the major U.S. medical technology trade association, which was founded in 1974. (Pam Bailey, who is board chair at medtech contract manufacturing giant Integer, was AdvaMed’s CEO from 1999 to 2005.)

McEvoy succeeds Abiomed’s former CEO Michael Minogue. She starts a two-year term as board chair at the same time that major medtech companies such as Johnson & Johnson face a host of challenges. Health provider customers in the U.S. and elsewhere are grappling with staffing shortages and operational challenges. There are macroeconomic headwinds, and the Chinese government is seeki…

The biggest cardiology tech stories from ACC.23

Medtronic, Abbott, iRhythm and more presented new data at a major cardiology conference, ACC.23. [Images courtesy of Medtronic, Abbott and iRhythm] Major medtech players presented a range of intriguing studies at a gathering of some of the biggest names in the cardiology tech space.

Some of the hottest topics were covered this past week at the American College of Cardiology’s Annual Scientific Session Together With the World Congress of Cardiology (ACC.23/WCC) in New Orleans.

Ablation, cardiac implants, monitors and imaging technology represented a handful of the technologies on display. Medtronic, Abbott, Boston Scientific, Edwards and more offered new data on their innovative technologies in these areas.

Here are some of the biggest stories that came out of the cardiology conference.

Excitement builds around using pulsed-field ablation to treat AFib

Medtronic, Boston Scientific and Johnson & Johnson MedTech’s Biosense Webster all released new…