J&J’s Biosense Webster launches IDE-cleared Qdot Micro RF ablation trial

Biosense Webster

Johnson & Johnson‘s (NYSE:JNJBiosense Webster said yesterday it launched a new FDA investigational device exemption study of its Qdot Micro radiofrequency ablation catheter exploring its use in treating symptomatic drug-refractory paroxysmal atrial fibrillation.

The first patient in the trial has already been treated, with the procedure taking place at NYU Langone Health’s Heart Rhythm Center, the Irvine, Calif.-based J&J division said.

“The delivery of 90 watts of RF power in a short, four-second ablation session is a significant advancement in the treatment of paroxysmal atrial fibrillation. We’re eager to see whether this new technology helps to reduce procedure time and improve clinical outcomes,” Dr. Larry A. Chinitz of NYU Langone Health’s Heart Rhythm Center, who treated the first patient in the study, said in a prepared statement.

Biosense Webster touted that its Qdot Micro RF cath is the first such catheter to deliver 90 watts of RF power in a short, four-second temperature controlled session, as ordinary RF ablation systems use power levels on average of between 20 to 40 watts and durations of 20 to 40 seconds.

The QDOT MICRO IDE trial aims to enroll a total of 185 patients in the U.S. at 30 centers to explore the use of the new RF ablation cath in treating patients with symptomatic drug-refractory paroxysmal atrial fibrillation.

“The Qdot Micro RF Ablation Catheter is an example of the innovations we’ve been focused on developing to elevate the standard of care for patients with Cardiac Arrhythmias. We believe this ablation catheter will revolutionize the field of ablation and hope it will make a meaningful difference in outcomes for both physicians and patients, just as the first catheter created by our co-founder, the late Will Webster, did,” Biosense Webster worldwide prez Uri Yaron said in a press release.

Last November, Biosense Webster said that it enrolled and treated the first patient in its Stellar U.S. investigational device exemption study.

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Report: J&J, plaintiffs close to settling majority of Pinnacle suits

Johnson & Johnson

Johnson & Johnson (NYSE:JNJ) subsidiary DePuy is close to settling the majority of consumers lawsuits against it related to the alleged defectiveness of its Pinnacle metal-on-metal hips, according to a Bloomberg report.

A federal jury in Dallas that was hearing testimony in damage claims brought by Pinnacle recipients was dismissed upon news of the settlement deal, according to the report.

“The parties have reached an agreement that hopefully will resolve most, if not all, of the litigation,” attorney Mark Lanier, who leads one of the consolidated 10,000-suit litigations against J&J, said, according to Blloomberg.

The company has not yet officially commented on the case, and may not speak on the matter in the future, DePuy spokesperson Mindy Tinsely said, according to the report.

The settlement comes only weeks after J&J’s DePuy reached a $120 million settlement deal with 46 U.S. Attorneys General in a case alleging that the company illegally promoted its Pinnacle Ultamet and ASR XL metal-on-metal hip implants.

Last December, another Bloomberg report suggested that J&J was willing to put more than $400 million on the table to settle consumer allegations that its Pinnacle line of metal-on-metal hips were defective and caused problems including metal poisoning.

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J&J Vision launches Tecnis Eyhance IOL in EU

Johnson & Johnson Vision

Johnson & Johnson (NYSE:JNJ) Vision said today that it launched its Tecnis Eyhance intraocular lens intended to treat cataracts in Europe.

The newly launched next-gen IOL, which has already received CE Mark clearance in the European Union, is designed to provide high-quality vision at both immediate and far distances, which the company touted as “an important first for the monofocal IOL category.”

The Tecnis Eyhance IOL is designed to provide improved intermediate vision when compared with standard aspheric monofocal IOLs, as well as 20/20 distance vision. J&J Vision said that patient-reported outcomes indicated that the Tecnis Eyhance IOL enabled improvements in physical tasks including walking on uneven surfaces and improved engagement in personal activities and hobbies.

“Today, patients with cataracts are forced to make a trade-off decision on their vision when selecting a monofocal intraocular lens. They can have corrected vision at a distance, but require glasses for near and intermediate vision activities, which refers to everything at arm’s length such as computer work or looking at a car speedometer. Tecnis Eyhance IOL offers high quality intermediate as well as distance vision, which is an important advancement to allow patients greater ease in certain activities in their day-to-day lives,”  Dr. Oliver Findl of Hanusch Hospital Vienna said in a prepared statement.

The company said it is launching the device initially in the UK, Italy, France, Spain and Germany.

“With the availability of Tecnis Eyhance IOL in Europe, we are proud to deliver another meaningful solution for patients with cataracts. We saw an opportunity to build upon the legacy of the Tecnis Family of IOLs and the proven design of our 1-piece platform to reimagine what was possible with the standard aspheric monofocal IOL,” J&J Vision surgical worldwide prez Tom Frinzi said in a press release.

Last June, J&J Vision said that the FDA approved its iDesign Refractive Studio for planning lasik eye procedures.

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Philly jury hits J&J’s Ethicon with $41m judgment in pelvic mesh case

gavel, legal

Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon has been hit with a $41 million verdict in a pelvic mesh product liability suit in Philadelphia, according to a report from the Mesh News Desk.

A jury in Philadelphia found that Ethicon’s Gynemesh, Prolift and TVT-O meshes were defective, and that the company was negligent in manufacturing the devices, according to the report.

The plaintiff, Suzanne Emmett, was implanted with a Prolift pelvic mesh to treat pelvic organ prolapse, a TVT-O mesh as a treatment for incontinence and a Gynemesh implant, according to the Mesh News Desk report.

The verdict includes $25 million in punitive damages, $15 million in compensation and $1 million to Emmett’s husband, according to the report.

The company has not yet commented officially on the case, and has not stated if it plans to appeal the decision.

Last November, a state judge in Pennsylvania ordered a new trial in a suit alleging a that a woman was injured by Ethicon’s TVT-Secur pelvic mesh implant.

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Johnson & Johnson plans €36M expansion in Ireland

Johnson & JohnsonJohnson & Johnson’s DePuy Synthes is investing €36 million in expanding research and development capabilities at its Ireland Innovation Center.

As part of the expansion, DePuy Synthes will establish a 3D-printing Development and Launch Center and implement the Johnson & Johnson 3D Bioprinting Laboratory.

Get the full story on our sister site, Medical Design & Outsourcing.

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FDA approves J&J’s Tremfya self-injection pen for psoriasis

FDA has approved Johnson & Johnson’s patient-controlled injector for Tremfya, a treatment for adults with moderate to severe plaque psoriasis.

The self-injection approval may help Tremfya compete with AbbVie’s (NYSE:ABBV) Humira pen, which was previously approved for self-injection by psoriasis patients.

Get the full story on our sister site, Drug Delivery Business.

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J&J’s Ethicon touts surgical staplers study

J&J Johnson & Johnson Ethicon Echelon Flex GST system

Ethicon’s Echelon Flex GST system [Image courtesy of Ethicon]

Johnson & Johnson’ Ethicon business is promoting the results of a head-to-head study between an Ethicon surgical stapler and a Medtronic stapler system.

Ethicon’s Echelon Flex GST system had a 20% staple-line air leak rate when tested out on pig lungs under modeled physiologic breathing conditions, versus a 44% rate for Medtronic’s Endo Gia with Tri-Staple technology.

Ethicon funded the research, which is being announced this week at the 2019 Society of Thoracic Surgeons annual meeting in San Diego.

Get the full story on our sister site Medical Design & Outsourcing.

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J&J may nab surgical robotics company Auris Health

Johnson & JohnsonJohnson & Johnson (NYSE:JNJ) intends to acquire surgical robotics company Auris Health, according to a report by Bloomberg News.

In May 2018, Auris inked an agreement with J&J’s division Ethicon’s NeuWave Medical subsidiary to develop systems for the robotically-assisted bronchoscopic ablation of lung lesions. J&J has been working with Alphabet‘s (NSDQ:GOOGLVerily Life Sciences on Verb Surgical’s prototype robot-assisted surgery platform.

J&J wants to spend more for Auris than the smaller company’s $2 billion valuation from its latest funding round, the Bloomberg report said, citing anonymous sources. Redwood City, Calif.-based Auris closed on a $220 million equity financing round in November to help support its next-generation Monarch robotic interventional platform. The funding round brings the total raised for the Monarch platform up to $700 million, Auris Health said.

The Monarch platform has FDA clearance for diagnostic and therapeutic bronchoscopic procedures. The system features a controller interface for navigating the integrated flexible robotic endoscope into the periphery of the lung and combines traditional endoscopic views with computer-assisted navigation based on 3D patient models, the company said.

Auris’ system uses a game-like controller that allows for more direct control than existing one-handed interfaces to maneuver the endoscope.

Formed by Intuitive Surgical (NSDQ:ISRG) founder Dr. Frederic Moll, closely held Auris bought Hansen Medical, which Moll co-founded, for $80 million in 2016.

Under the Auris-NeuWave agreement, both companies are helping to develop an integrated system for robotic control, navigation and application of bronchoscope-delivered microwave ablation. The bronchoscope in development will be equipped with a small camera and accessory channel to allow tools to enter the lungs through the mouth, Auris said in May.

Yesterday, J&J reported a return to black ink for the fourth quarter and set its financial forecast for the rest of the year. The New Brunswick, N.J.-based healthcare giant posted profits of $3.04 billion, or $1.12 per share, on sales of $20.39 billion for the quarter, for a 1.0% top-line gain over Q4 2017, when J&J posted losses of -$10.71 billion.

Auris declined to comment on the possible acquisition. J&J did not respond to a request for comment. J&J closed the $2.1 billion sale of its LifeScan blood glucose monitoring subsidiary to private equity player Platinum Equity in October 2018.

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J&J settles hip implant litigation with AGs for $120m

Johnson & Johnson

Johnson & Johnson (NYSE:JNJ) subsidiary DePuy has reached a $120 million settlement deal with 46 U.S. Attorneys General in a case alleging that the company illegally promoted its Pinnacle Ultamet and ASR XL metal-on-metal hip implants, according to a recent posting from New York AG Letitia James.

The New Brunswick, N.J.-based company faced allegations that it made misleading claims related to the longevity, or survivorship, of its metal-on-metal hip implants, according to the release.

Despite the National Joint Registry of England and Wales reporting a 7% revision rate at three years, DePuy advertised that its ASR XL hip implant had a survivorship of 99.2% over the same period. The company also reported a 99.8% and 99.9% survivorship rate at three and five years for its Pinnacle Ultamet, respectively, while the same national registry reported a 2.2% and approximately 4.3% revision rate at three and five years, according to the release.

The ASR XL was recalled in 2010, while DePuy discontinued its Pinnacle Ultamet hip implant in 2013, according to the release.

In addition to allegations of providing misleading data on longevity and efficacy of the hip implants, DePuy also faced claims that patients who required revision surgery experienced persistent groin pain, allergic reactions, tissue necrosis and the build-up of metal ions in the blood, according to the NY AG’s release.

As part of the company’s Consent Judgement, DePuy “agreed to reform how it markets and promotes its hip implants,” according to the release.

DePuy agreed to six new requirements related to its marketing of hip implants: basing survivorship, stability and dislocation data on scientific information and the most recent registry dataset for any such device; maintaining a post market surveillance program and complaint handling program; updating and maintaining internal product complaint handling operating procedures, including training complaint reviewers; updating and maintaining a system for tracking and analyzing product complaints that don’t meet the definition of Medical Device Reportable Events; maintaining a quality assurance program including audit procedures for those non-MDRE complaints; performing quarterly reviews of complaints and investigating subgroups with high incidence rates of adverse events to identify causes and alter promotional practices appropriately.

“Doctors and their patients need to have accurate and up to date information to ensure that patients are receiving appropriate healthcare. Companies should never be allowed to freely mislead the public, especially when there are health concerns involved. This settlement serves as an important message that deceptive and false medical practices will never be tolerated,” AG James said in a press release.

New York AG Letitia James said that New York will receive approximately $4.7 million of the settlement.

The investigation was led by Texas and South Carolina and joined by New York, Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Mexico, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Dakota, Tennessee, Utah, Vermont, Virginia, Washington, and Wisconsin.

Earlier this month, India’s Supreme Court reportedly approved a compensation plan for patients there who were implanted with a since-recalled metal-on-metal hip made by Johnson & Johnson.

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Johnson & Johnson swings to Q4 black

Johnson & JohnsonJohnson & Johnson (NYSE:JNJ) today reported a return to black ink for the fourth quarter and set its financial forecast for the rest of the year.

The New Brunswick, N.J.-based healthcare giant posted profits of $3.04 billion, or $1.12 per share, on sales of $20.39 billion for the quarter, for a 1.0% top-line gain over Q4 2017, when J&J posted losses of -$10.71 billion.

Adjusted to exclude one-time items, earnings per share were $1.97, 2¢ ahead of the consensus forecast on Wall Street, where analysts were looking for sales of $20.17 billion.

Full-year profits were $15.30 billion , or $5.61 per share, on sales of $81.58 billion. Adjusted EPS came in at $8.18, again 2¢ above The Street, where analysts were looking for sales of $8.37 billion.

“Johnson & Johnson delivered another year of strong operational sales growth of 6.3% and achieved our 35th consecutive year of adjusted operational earnings growth at 9.8% in 2018. This can be attributed to accelerated underlying sales performance across each of our businesses, where we also leveraged our scale across the enterprise to improve margins,” chairman & CEO Alex Gorsky said in prepared remarks. “Looking ahead, the strength of our broad-based business and disciplined approach to portfolio management positions us to continue to fuel investments in innovation that enable us to capitalize on strategic opportunities and deliver strong performance over the long-term.

Johnson & Johnson said it expects to log adjusted EPS of $8.50 to $8.65 this year, on sales of $80.4 billion to $81.2 billion – well below The Street’s consensus at adjusted EPS of $8.61 and sales of $82.68 billion.

JNJ shares were off -1.5% to $128.71 apiece today in pre-market trading.

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