Bayer loses bid to toss some claims in Essure class action suit

A federal judge in Philadelphia will allow six women who are suing Bayer (ETR:BAYN) over its Essure sterilization implant to proceed with their personal injury claims and three others to pursue their breach-of-warranty claims. One woman who became pregnant following implantation with Essure will be able to pursue her claim that Bayer fraudulently concealed the risk of pregnancy, the judge ruled.

Bayer had filed a motion for partial summary judgment on all 12 plaintiffs’ claims in the class action suit, citing statutes of limitations. Judge John Padova of the Eastern District of Pennsylvania granted Bayer’s motion for summary judgment on the personal injury claims of six of the women and on some or all of the breach-of-warranty claims of nine women.

The women had the Essure coils implanted in their fallopian tubes between 2006 and 2013 and claimed they suffered a variety of ailments afterward, including pain, bleeding and autoimmune disorders. Two became pregnant.

Under Pennsylvania law, the women had two years to file claims seeking damages for personal injury and four years to file claims for breach of warranty. Bayer and some of the women differed on when the clock began to run, based on when the women — or their doctors — connected their health problems to Essure and when they filed suit.

Padova heard the arguments on Bayer’s motion on February 11. Bayer took Essure off the market in the United States in December 2018. In April of 2018, the FDA put restrictions on U.S. sales of Essure, a small metal coil that’s placed in the fallopian tubes via catheter, after concluding that some patients were not adequately warned of its risks.

The post Bayer loses bid to toss some claims in Essure class action suit appeared first on MassDevice.

Gynesonics touts fibroid study’s long-term outcomes

A long-term retrospective study of patients treated with Gynesonics’ Sonata uterine fibroid treatment system revealed low rates of surgical reintervention, improved symptom severity and quality of life, the company said today.

Patients at the study site in Monterrey, Mexico were treated with the Sonata system, designed to provide incisionless transcervical radiofrequency energy ablation of uterine fibroids under intrauterine ultrasound guidance. The mean follow-up period for the patients enrolled was 5.4 years.

Highlights from the study include:

  • No surgical reinterventions in the first 3.4 years.
  • Annualized surgical reintervention rate per year of 2.2%.
  • 11.8% cumulative reintervention rate through 5.4 years average follow-up.
  • 37 point mean improvement in symptom severity score at follow-up.
  • 49 point mean improvement in health-related quality of life at follow-up.

“We have evaluated many new fibroid treatment innovations in our facility and are especially impressed with the patient results achieved with Sonata over this extended time frame,” said Jose Gerardo Garza-Leal, M.D., of the Universidad Autonoma de Nuevo Leon in Monterrey in a prepared statement from Gynesonics. “Such lasting results are even more impressive considering the low risk and quick recovery our patients experienced with the Sonata procedure, especially when compared to other fibroid treatment alternatives.”

Redwood City, Calif.-based Gynesonics said its Sonata system platform provides transcervical access to a wide range of fibroid types, most of which cannot be treated with current operative hysteroscopy methods.

In January, the company released 12-month results from an FDA investigational device exemption pivotal trial of Sonata at 21 outpatient sites in the U.S. and a single site in Mexico. Data from the trial indicated that 99% of patients required no surgical reinterventions for heavy menstrual bleeding, with 97% reporting satisfaction with the treatment. Symptom improvement was reported by 96% of patients, with 95% reporting a reduction in menstrual bleeding. A total of 65% of the trial’s 147 patients reported at least a 50% reduction in menstrual bleeding.

The National Institutes of Health estimate 200,000 hysterectomies are performed in the U.S. each year specifically to address symptomatic uterine fibroids. With an estimated volume of more than 1 million annual global uterine fibroid procedures, Gynesonics projects a $3 billion-$4 billion global market opportunity for its Sonata system, including a market opportunity of more than $1 billion in the U.S. alone.

The post Gynesonics touts fibroid study’s long-term outcomes appeared first on MassDevice.

How AI can detect cervical cancer

Cervical cancer cells (Image from National Cancer InstituteWinship Cancer Institute of Emory University)

Researchers have developed a computer algorithm that they say can analyze digital images of a woman’s cervix and accurately identify precancerous changes that require medical attention. This artificial intelligence approach, called automated visual evaluation, has the potential to revolutionize cervical cancer screening, particularly in low-resource settings.

Led by investigators from the National Institutes of Health and humanitarian tech investment fund Global Good, the researchers used comprehensive datasets to “train” a machine-learning algorithm to recognize patterns in complex visual inputs, such as medical images. The findings were confirmed independently by experts at the National Library of Medicine. The results appeared in the Journal of the National Cancer Institute (NCI).

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

The post How AI can detect cervical cancer appeared first on MassDevice.

Clinical Innovations purchases Australian distributor JB Medical Supplies

Labor, delivery and neonatal intensive care devices company Clinical Innovations (Salt Lake City) has acquired Australian distributor JB Medical Supplies.

The deal, announced yesterday, is meant to bolster Clinical Innovations’ position in Australia. JB Medical Supplies will operate as a wholly owned subsidiary of Clinical Innovations.

Financial terms of the deal were not disclosed.

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

The post Clinical Innovations purchases Australian distributor JB Medical Supplies appeared first on MassDevice.

Power morcellation: Questions linger for controversial tech

Dr. Amy Reed’s tragic case brought to light the cancer risks posed by power morcellation. Her death hasn’t stopped lingering questions about the technology.

Power morcellators were used for 20 years to laparoscopically remove fibroids, benign tumors of the uterus, raising not a single adverse event report with the FDA. That all changed in 2013, when Dr. Amy Reed, an attending physician at Beth Israel Deaconess Medical Center, underwent a myomectomy using power morcellation at nearby Brigham & Women’s Hospital.

Reed’s fibroids were not benign, but instead a malignant form of cancer called uterine sarcoma that’s difficult to distinguish from benign tumors. Days after her procedure, Reed’s formerly treatable condition had been upstaged to a deadly cancer.

It turned out that power morcellation, a laparoscopic procedure in which surgeons use the device to mince the tumors, can seed malignant cells throughout the abdomen, drastically accelerating the cancer’s advance. Reed died last year at 44 of complications from her 2013 myomectomy, but not before she and her husband, Dr. Hooman Noorchasm, mounted a successful public health campaign to raise awareness of the risks posed by power morcellation. In 2014 the federal safety watchdog issued a black box warning for power morcellators, prompting Johnson & Johnson to pull its power morcellator from the market.

With the devices gone, a void emerged in the market – women who would have undergone a laparoscopic procedure with a morcellator now faced an open uterine resection. Organizations including the American College of Obstetricians & Gynecologists teamed with the Agency for Healthcare Research & Quality to lobby for the FDA to reconsider its 2014 guidance, arguing that patients need a laparoscopic option for tissue removal.

Meanwhile, some medtech entrepreneurs saw the risks posed by morcellators as an opportunity to create a device that would address the morcellator’s shortcomings. Eximis Surgical, a tiny Colorado-based company, set out to do just that.

Eximis came across Noorchasm’s radar after announcing that it raised $5 million from 33 investors to fund the development of its laparoscopic tissue removal system. He noticed that on their LinkedIn account, Eximis named Reed as the inspiration behind their technology. Noorchasm penned a letter to Eximis executives and published it online, asking them to remove any reference to Reed and, among other things, acknowledge that their technology is simply a resurrected version of a power morcellator.

“What they’re marketing is something that goes directly in opposition to what Amy and myself have been speaking out against,” he told Medical Design & Outsourcing. “It doesn’t matter what words you use, it doesn’t matter if you say morcellate, slice up, dice up, XCor out – if you take a tumor that has malignant potential and you mince it up, you’re exposing that patient to the risk of their cancer being upstaged.”

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

The post Power morcellation: Questions linger for controversial tech appeared first on MassDevice.

British health watchdog recommends vaginal mesh ban

Share

Pelvic meshA British health watchdog reportedly plans to recommend that the National Health Service there ban vaginal mesh implants to treat pelvic organ prolapse, citing “serious but well-recognized safety concerns.”

In recommending that the implants be limited to research use only, the U.K.’s National Institute for Health & Care Excellence said “evidence of long-term efficacy [for implants treating organ prolapse] is inadequate in quality and quantity,” according to the BBC.

Randomized, controlled trials “showed no added benefit of using mesh compared with native tissue repair,” according to the NICE report. “[W]hen complications occur, these can be serious and have life-changing consequences.”

More than 92,000 women had vaginal mesh implants in England between April 2007 and March 2015, the BBC reported, citing NHS data. About one in 11 women experienced problems with the implants, according to the data.

The proposed ban does not mention the use of pelvic mesh to treat female urinary incontinence, the British news service said.

In the U.S., tens of thousands of product liability lawsuits have been filed against medical device companies over their respective pelvic mesh offerings.

Last month a federal appeals court upheld a plaintiff’s $27 million win over Boston Scientific (NYSE:BSX) in a product liability lawsuit brought over its Pinnacle pelvic mesh, a month after Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon was hit with a $57.1 million verdict in a pelvic mesh case out of Pennsylvania.

Teva closes Plan B emergency contraception sale in $2.3B restructuring effort

  • 7 medtech stories we missed this week: Nov. 3, 2017

    From Hologic’s new product launch to CapsoVision gettting CE Mark approval, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Hologic launches new MyoSure device Hologic announced in a Nov. 1 press release that it has launched its MyoSure Manual Device in the U.S. The device is designed […]

  • OCTANe: Southern California leads in medtech jobs and job creation

    Southern California in recent years provided the highest level of employment to medtech, according to U.S. Dept. of Commerce data compiled by OCTANe. Bill Carpou, OCTANe’s president and CEO, presented the statistics during his welcome address at the Medical Technology Innovation Forum (MTIF) earlier this week. The area including Los Angeles, Orange County, and San Diego employed […]

  • FDA issues final guidance on medical device changes that need new 510(k) submissions

    By Stewart Eisenhart, Emergo Group Medical device regulators at the US Food and Drug Administration have published final guidance explaining when changes to registered devices warrant filing new 510(k) premarket notifications to the agency. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only […]

  • Medtronic’s CEO thinks value-based care is really important: Here’s why

    Value-based care is the future of healthcare, and according to CEO Omar Ishrak, it is the past, present and future of Medtronic. Ishrak spoke at OCTANe’s Medical Technology Innovation Forum (MTIF) this week about the opportunity and responsibility medical device companies have when it comes to adopting value-based care models.  In this future, Ishrak sees […]

  • 9 exhibitors to check out at MD&M Minneapolis

    MD&M Minneapolis is an event that brings together more than 5,500 medtech professionals and more than 600 suppliers together at one of the largest medical device industry hubs in the United States. Here are nine exhibitors showcasing some of their latest technologies and services at the show, which takes place Nov. 8–9 at the Minneapolis […]

  • This nerve-blocking treatment could treat asthma and heart failure

    Electrical nerve-blocking implants could help treat asthma and heart failure, according to new research from Case Western Reserve University. Niloy Bhadra and Kevin Kilgore, professors of biomedical engineering and orthopedic surgery respectively, have been working on the nerve-blocking research since 2000. The research blocks unwanted generation of nerve impulses in a variety of clinical applications. […]

  • The Mammography Quality Standards Act: A 25-year public health success story

    By: Dr. Helen Barr Mammography has been widely used as a screening tool to detect early-stage breast cancer since the mid-1960s. As the use of the technology expanded it became clear that there were wide variations in the quality of the mammograms and the dose being delivered to patients. Following a series of hearings, Congress stepped […]

  • Nelson Labs parent Sterigenics buys Toxikon’s European lab business

    Sterigentics International is seeking to turn its Nelson Labs business into a global extractables and leachables lab testing platform through its acquisition of Toxikon’s European division. The purchase of Toxikon Europe, announced yesterday, represents a capabilities expansion when it comes to serving the pharmaceutical and medical device industries. Sterigenics’s Nelson Labs business will now offer Toxikon […]

  • High-volume manufacturing: 4 points to consider before you scale up

    Scaling to high-volume manufacturing requires companies to think ahead and prepare for the future early in the product lifecycle. Here are four points to reflect upon before your company scales up. Gavin Wadas, B. Braun Medical, OEM Division High-volume manufacturing typically involves the introduction of automation into the medical device fabrication and assembly process. A […]

  • How Igus moving plastic components are enabling medtech innovation

    Advanced plastic components maker Igus sees more medical sector opportunities. Here’s how its e-chains, bearings and linear systems are enabling innovation.  Igus – maker of advanced plastic components including e-chain cable carriers, bearings and linear systems – has its main medical customers in Europe. But that could soon change. The company plans to sell to […]

  • DeviceTalks West: Expertise you need to know

    Medical device suppliers are light years away from the days when they merely filled orders to spec for medtech OEMs – as a visit to the upcoming DeviceTalks West will quickly confirm. From incorporating steerability into catheters to getting validation and testing done right, the companies serving the medical device industry have become specialized experts in […]

  • Teva closes Paragard sale to CooperSurgical

    Share

    The Cooper Co.'s, Teva PharmaceuticalsTeva Pharmaceuticals (NYSE:TEVA) said today that it closed the $1.1 billion cash sale of its Paragard intrauterine copper contraceptive device to Cooper Cos.‘ (NYSE:COO) CooperSurgical unit.

    The deal included Teva’s manufacturing facility in Buffalo, N.Y., the pharma company reported.

    The move is part of Teva’s efforts to restructure its business, narrowing its focus on CNS and respiratory conditions. The company also plans to divest of its oncology and pain businesses in Europe. In September, Teva inked deals to sell off the rest of its women’s health biz.

    “With completion of the sale of Paragard, Teva demonstrates strong execution of our strategic divestiture plan,” Teva’s out-going president & CEO Yitzhak Peterburg said in prepared remarks. “We now have an infusion of $1.1 billion to progress the repayment of term loan debt and are on track to deliver on our promise to generate net proceeds of at least $2 billion from the divestiture of non-core assets. We are very pleased to have completed this sale to CooperSurgical which will help to not only allow for greater focus within Teva’s global specialty medicines business but also assure that patients in the U.S. continue to benefit from access to this important contraceptive product.”