Johnson & Johnson MedTech Archives - Medical Design Sourcing

J&J’s Abiomed has a Class I Impella recall with 49 deaths related to issue

This illustration shows the Impella 5.5 with SmartAssist placed in the heart. [Image courtesy of Abiomed]The FDA deemed a recall of heart pumps from Johnson & Johnson MedTech’s (NYSE:JNJ) Abiomed Class I, the most serious kind.

Abiomed reports 129 serious injuries, including 49 deaths, related to the issue of potential cuts in the wall of the heart.

This recall (a correction and not a product removal) affects a number of Impella pumps in the U.S. That includes Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAsist and Impella LD.

Impella pumps provide short-term support for the ventricles during high-risk catheter-based percutaneous coronary interventions (PCIs). Uses also include for ongoing cardiogenic shock, open-heart surgery or cardiomyopathy. The therapy aims to reduce the work of the heart’s ventricles and support the circulatory system.

Abiomed recalled the left-sided blood pumps in this…

Johnson & Johnson MedTech partners with Nvidia on AI in surgery

Johnson & Johnson MedTech announced today that it plans to accelerate and scale AI for surgery in partnership with Nvidia.

The two companies paired up to support increased access to real-time analysis and global AI algorithm availability. They hope to affect surgical decision-making, education and collaboration across the connected operating room (OR).

This marks the latest medtech collaboration involving Nvidia, a leader in AI computing. Asensus Surgical linked up with Nvidia last year to deliver novel clinical intelligence to surgeons in surgical robotics. Medtronic also partnered with Nvidia to enable an AI Access platform to boost the GI Genius intelligent endoscopy module’s capabilities.

Read more on Nvidia and its use of generative AI in the pharmaceutical industry here.

According to a news release, the companies executed a memorandum of understanding to accelerate AI for Johnson & Johnson MedTech’s extensive surgical technolog…

J&J’s Biosense Webster’s Varipulse PFA system wins CE mark

The Vaipulse pulsed field ablation platform now has regulatory approval to treat AFib in Europe. [Image courtesy of Biosense Webster]J&J MedTech’s Biosense Webster unit announced today that it won CE mark approval for its Varipulse pulsed field ablation (PFA) platform.

European officials approved Varipulse for the treatment of symptomatic drug refractory recurrent paroxysmal AFib using PFA. Varipulse features the Varipulse catheter, a variable-loop multielectrode catheter. The platform also includes TruPulse generator and the Carto 3 3D cardiac mapping system. According to Biosense Webster, Carto integration enables an intuitive and reproducible workflow with real-time visualization and feedback mechanisms.

In addition to European approval, Varipulse holds approval in Japan but remains investigational in the U.S. Biosense Webster hopes to become the third company to garner FDA approval for AFib-treating PFA technology. Boston Scientific won FDA approval …

J&J’s Biosense Webster begins trial for Laminar left atrial appendage elimination device

Johnson & Johnson’s Biosense Webster today announced the start of patient cases with the investigational Laminar LAAX system.

In November 2023, Johnson & Johnson MedTech completed a $400 million acquisition of Laminar, With that buy, the company brought in Laminar’s left atrial appendage elimination (LAAX) technology. Unlike other LAA technologies, which exclude or occlude the LAA, Laminar’s aims to completely eliminate it to treat AFib. Rather than use catheter-based devices to plug and occlude the LAA, Laminar’s approach utilizes rotational motion.

Irvine, California-based Biosense Webster commenced the patient cases as part of a pivotal FDA investigational device exemption (IDE) study. Dr. Saibal Kar (Los Robles Health System) and Dr. Devi Nair (St. Bernard’s Heart & Vascular Center) performed the procedures. Biosense Webster said they mark a “significant milestone” on the road to non-valvular AFib (NVAF) treatment.<…

Johnson & Johnson launches new intraocular lens in EMEA

Johnson & Johnson MedTech announced that its Vision unit made the Tecnis PureSee lens available in the EMEA region.

Tecnis PureSee is a purely refractive, presbyopia-correcting intraocular lens (IOL). It features a proprietary design aimed at delivering uninterrupted, high-quality vision. Johnson & Johnson says it offers high best-in-category contrast and low-light performance compared to a monofocal IOL.

According to a news release, current lenses require patients to make trade-off decisions. Some lenses offer clear sight at all distances without spectacles but might lead to glares and halos. J&J said Tecnis PureSee combats those issues and improves overall outcomes for both patients and surgeons.

“Cataract surgery is the number one surgery performed globally, with 28 million procedures each year. But only 10-15% of patients are getting advanced optical IOLs specifically designed for astigmatism and presbyopia,” said Jacqueline Henderson, pr…

Johnson & Johnson MedTech expands Ethicon operations in Puerto Rico

Manatí, Puerto Rico [Image courtesy of Google]Johnson & Johnson MedTech (NYSE: JNJ) + announced plans to expand an existing manufacturing facility in Puerto Rico to support Ethicon products.

According to a company spokesperson, the expansion plans in Manatí, Puerto Rico, aim to increase production capacity for key Ethicon products. The company expects to add an estimated 100,000 square feet of manufacturing capacity.

Customer demand has led to a need for supply chain expansion, according to J&J MedTech and Ethicon. The company feels refurbishing the Manatí site enables the shifting of key Ethicon manufacturing at its San Lorenzo facility to the new site to continue meeting demand.

According to The San Juan Daily Star, Puerto Rico Gov. Pedro Pierluisi Urrutia and Economic Development and Commerce (DDEC by its Spanish acronym) Secretary Manuel Cidre Miranda participated in Johnson & Johnson’s announ…

Biosense Webster supports duo of new studies using Varipulse pulsed field ablation tech

The Varipulse pulsed field ablation system. [Image courtesy of Biosense Webster]Biosense Webster today announced its support for two collaborative studies using its Varipulse pulsed field ablation (PFA) platform.

Johnson & Johnson MedTech’s electrophysiology unit says the two collaborative studies aim to better understand the use and workflows of the investigational platform in treating diverse arrhythmias.

Varipulse features the Varipulse catheter, a variable-loop multielectrode catheter, the TruPulse generator and the Carto 3 3D cardiac mapping system. This platform holds approval in Japan, while it remains unavailable for sale in the EU and U.S.

Earlier this week, Biosense Webster shared positive one-year results from multiple studies evaluating Varipulse. Both studies demonstrated significant freedom from AFib recurrence.

Pulsed field ablation is one of the hottest spaces in medtech. Biosense Webster hopes to use Varipulse to establish itself…

J&J’s Cerenovus launches next-gen stroke revascularization catheter

The CereGlide 71 catheter. [Image from Johnson & Johnson’s Cerenovus]Johnson & Johnson MedTech’s Cerenovus today announced the launch of its next-generation CereGlide 71 intermediate catheter with TruCourse.

The catheter’s indication covers the revascularization of patients suffering from acute ischemic stroke. It joins the company’s planned CereGlide family of catheters set to enhance the Cerenovus Stroke Solutions portfolio. The company said it optimized the system for effective direct aspiration and for the delivery of compatible stent retrievers. That includes the EmboTrap III revascularization device into the neurovasculature.

Cerenovus equipped the system with TruCourse technology to increase the flexibility of the device. It designed it to help physicians with improved navigation and access to clots, even in challenging anatomical conditions. The company said it provides optimal compatibility, durable delivery and reliable tr…

Biosense Webster has positive Varipulse pulsed field ablation data

The Varipulse pulsed field ablation system. [Image courtesy of Biosense Webster]Biosense Webster announced positive one-year results from multiple studies evaluating its Varipulse pulsed field ablation (PFA) system.

Johnson & Johnson MedTech’s electrophysiology unit shared results from its inspIRE and admIRE studies. The inspIRE study looked at pulmonary vein isolation using a variable loop catheter with 3D mapping integration. The admIRE study used a variable loop circular catheter with 3D mapping integration.

Both trials used the Varipulse platform, which features the Varipulse catheter, a variable-loop multielectrode catheter, the TruPulse generator and the Carto 3 3D cardiac mapping system. This platform holds approval in Japan, while it remains unavailable for sale in the EU and U.S.

Biosense Webster presented both sets of data at the 29th International AF Symposium last week.

“Biosense Webster is committed to bringing forward a versat…

Study backs Biosense Webster low/zero fluoroscopy AFib ablation

[Image courtesy of Biosense Webster]Johnson & Johnson MedTech’s Biosense Webster announced positive findings from real-world data looking at its AFib ablation technology.

The study evaluated the safety and effectiveness of low/zero fluoroscopy AFib ablation. Results supported the use of workflows to reduce radiation exposure during catheter ablation for treating paroxysmal AFib. Data also showed sustained safety, efficacy and long-term patient outcomes comparable to traditional procedures.

Biosense Webster says its workflow is the first and only of its kind available in a radiofrequency (RF) cardiac ablation device. The FDA approved this workflow last year and the company offers it with several products in its ablation portfolio. That includes the SmartTouch SF catheter, a commonly-used catheter for RF ablation compatible with the Carto 3 mapping system.

The company says its updated workflow shows that direct imaging guidance — like ultrasound — c…

10 surgical robotics companies you need to know

The surgical robotics space saw a major shakeup last year. The da Vinci SP surgical robotics system [Image courtesy of Intuitive Surgical]“Robotics is hard. Robotics in healthcare is hard.”

Hani Abouhalka, Johnson & Johnson’s company group chair for Robotics & Digital, said those words at our DeviceTalks West event in California in October.

It pretty much sums up the situation for medtech companies large and small that sought to compete against Intuitive in the soft-tissue surgical robotics space. Despite the increased competition, Intuitive remains the undisputed leader. It’s even moving forward on a next-gen da Vinci robot.

For its part, Johnson & Johnson is sticking with plans to develop its Ottava surgical robot. J&J now plans to submit Ottava for FDA investigational device exemption (IDE) in the second half of 2024 in order to start clinical trials.

Even though it is sticking with robotic surgery, J&J laid off employees in th…

Johnson & Johnson MedTech reports 13% sales uptick in Q4, has positive ablation outlook

Johnson & Johnson (NYSE: JNJ) + reported more MedTech growth as its fourth-quarter results came in ahead of the consensus forecast.

Shares of JNJ rose slightly before the market opened on the back of the results.

The New Brunswick, New Jersey-based company posted profits of $4.1 billion. That equals $1.70 per share on sales of $21.4 billion for the three months ended Jan. 1, 2024. Johnson & Johnson recorded a 28% bottom-line gain on sales growth of 7.3%.

Adjusted to exclude one-time items, earnings per share totaled $2.29. That landed 1¢ ahead of expectations on Wall Street. Sales also topped projections as analysts expected revenues totaling $20.99 billion.

“Johnson & Johnson’s full year 2023 results reflect the breadth and competitiveness of our business and our relentless focus on delivering for patients,” Joaquin Duato, chair and CEO, said in a news release. “We have entered 2024 from a po…