More device shortages pegged to sterilization plant shutdown

Cardinal Health’s Accu-Trace intrauterine pressure catheter (Image from Cardinal Health)

More medtech companies are experiencing shortages of medical devices due to the sudden closure in February of a Sterigenics sterilization plant.

Officials from Cardinal Health (NYSE:CAH), and Guerbet (EPA:GBT) have written letters to customers indicating that certain devices are already in short supply or may experience shortages, Medical Device & Outsourcing has learned.

The letter from Cardinal Health (Dublin, Ohio) said that the company expects a shortage of its Kendall Accu-Trace intrauterine pressure catheter until early August. This device is placed inside a pregnant woman’s uterus to monitor uterine contractions during labor. The letter from Guerbet (Villepinte, France) said that disposable power injectors used with its Optistar, Optivantage and Illumena contrast delivery systems may experience shortages. Officials from those companies did not immediately respond to requests for comment.

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Australia’s TGA considering, but not yet implementing, textured breast implant ban

Australia's TGA

Australia’s TGA said yesterday that it is seeking new data from suppliers of textured breast implants, which have been linked to a rare immune-system cancer, before making a decision on whether or not to suspend or cancel those products from its Register of Therapeutic Goods.

The regulatory body gave suppliers of the devices 10 working days to respond to the requests for more information, including dates they began to supply the devices and samples of the implants, according to a TGA release.

The decision comes after the convening of a breast implant expert panel on April 8, following recent decisions made in Canada and France to remove select implants from the market.

The implants have been linked to breast implant-associated anapestic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma.

The TGA said that the panel it convened discussed current data on the implants associated with BIA-ALCL and identified gap in the data that affected estimation of the true rate of the cancer in the country.

The regulatory body said that as of April 8, it has received 76 reports of BIA-ALCL in Australian women. The agency said that there are approximately 13,000 to 17,000 breast implant procedures performed in the country each year.

The panel also discussed the benefits of textured implants, particularly for reconstructive new surgery, and made suggestions including a need to update the TGA’s website with risks and benefits and to better encourage use of the Australian Breast Device Registry.

The TGA said that like the FDA and many other regulatory bodies, it has been monitoring BIA-ALCL cases since 2011, adding that the first adverse event report it received related to the cancer came in in 2009.

The agency said that textured implants of varying roughness are used in 82% of operations in the country.

Last month, a panel of experts convened by the FDA said that there’s not enough data to pull textured breast implants from the market over concerns that they may be linked to a type of immune system cancer.

AirXpanders touts study results

AirXpanders (ASX:AXP) said that a retrospective clinical study has concluded that the use of its AeroForm tissue expanders may be associated with reduced infection rates, less medical treatment and lower costs for patients and health systems.

The Palo Alto-based company makes the AeroForm tissue expander for post-mastectomy breast reconstruction. The device is designed to expand and stretch the skin and underlying muscle prior to a permanent breast implant using small amounts of CO2 up to three times a day.

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Health Canada notifies Allergan on intent to suspend Biocell breast implant license

Allergan - updated logo

Health Canada said yesterday that it plans to suspend Allergan‘s (NYSE: AGN) licenses to sell its Biocell breast implants in the region due to a possible association with a rare immune system-cancer.

The move follows the agency’s completion of a scientific assessment of macro-textured implants, which it said is part of a larger safety review of breast implants and their association with breast implant-associated anapestic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma.

Health Canada said it launched the review last November due to an increase in Canadian and international cases of BIA-ALCL, adding that it has been notified of 28 confirmed cases. A total 86% of those, or 24, involved Allergan’s Biocell breast implant, the agency said.

The agency said that it would provide Allergan 15 calendar days to present new evidence, and that if a satisfactory response is not received by then, “it is Health Canada’s intention that the Biocell medical device licenses will be suspended.”

Health Canada said that it continues to monitor and review scientific data on the safety of the implants, and that it is engaging with other regulatory bodies globally including the FDA and France’s National Agency for Medicines and Health Products.

The agency said that it plans to provide a full safety review of breast implants and BIA-ALCL by the end of April, and that it will “not hesitate to take further action, as necessary.”

In addition, the watchdog said that it has begun a second safety review of systemic symptoms associated with breast implants, which it plans to make public this summer.

Last December, Allergan said that it removed its textured breast implants from the market in Europe following a recall request from French regulators.

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Report: France to ban textured breast implants

France's ANSM

France is planning to ban textured breast implants, which have been linked a rare immune-system cancer, according to a report from France24.

France’s National Agency for Medicines and Health Products began informing manufacturers on April 2 of its plans to ban manufacturing, distribution, importing, exporting, promotion and wearing of textured breast implants and polyurethane breast implants, according to the report.

The soon-to-be-banned implants have been linked to breast implant-associated anapestic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma.

France’s ANSM has been tracking individuals with breast implants since 2011, according to the France24 report, the same year the FDA said it began tracking and reporting cases of BIA-ALCL.

In February, the FDA said that it has received reports of 457 unique cancer cases related to breast implants since 2010, including nine patient deaths.

The ANSM said it has recorded 53 cases of BIA-ALCL, with an over-representation amongst individuals with textured breast implants, according to the report.

Breast implant maker Polytech Health & Aesthetics responded to the ban saying that it objects to the conclusions of the ANSM, despite the fact that both textured implants are an “integral part of the company’s portfolio.”

“The ANSM decision is not based on any scientific proof and surgeons and their patients in France will now be offered very limited options, that may not allow them to achieve a safe and optimal surgical result,” Polytech said in a prepared statement.

The company said that it will continue to sell its POLYsmooth and MESMOsensitive micro-textured implants in France.

“As a leading manufacturer of breast implants, it is our obligation to educate both surgeons and patients on the subject of BIA-ALCL, with evidence-based information, recent medical publications and our gathered knowledge. Even as it is a very rare complication, we take the appearance of BIA-ALCL very seriously. However, we believe that a ban of textured and polyurethane-coated implants is a false decision in terms of the overall patient safety, when it is based on the currently available facts,” Polytech CEO Wolfgang Steimel said in a press release.

Last December, Allergan (NYSE: AGN) removed its textured breast implants from the market in Europe following a recall request from French regulators.

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FDA nixes Evoke Pharma’s gastro nasal spray

The FDA has rejected Evoke Pharma’s (NSDQ:EVOK) application for a metoclopramide nasal spray for diabetic women with gastroparesis.

The Solana Beach, Calif. company’s stock price tumbled 40% on the news yesterday that the agency had found dosing inconsistencies in the pivotal pharmacokinetic study for the spray, Gimoti. In an earlier multi-disciplinary letter to the company, the FDA had cited concerns with quality control, dosing, and a lack of information to support sex-based differences in efficacy.

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

Channel Medsystems wins PMA for Cerene cryoablation device

Channel MedsystemsChannel Medsystems last week won pre-market approval from the FDA for its Cerene endometrial cryoablation device, starting the clock on a mandatory three-year post-approval study.

Cerene, which is designed to treat heavy but benign bleeding in premenopausal women for whom child bearing is complete, won CE Mark approval in the European Union in June 2017. The PMA granted March 28 is based on 12-month data from the 242-patient Clarity pivotal trial, which must now be extended for another 36 months, according to the FDA.

Emeryville, Calif.-based Channel Medsystems must follow at least 85% of Clarity patients out to three years, documented by two years worth of bi-annual reports detailing a variety of outcomes, the federal safety watchdog said.

“We are extremely pleased by the results of the Clarity study and the positive feedback we have received about the Cerene device, both from study investigators and numerous gynecologists surveyed,” president & CEO Ric Cote said in prepared remarks. “The Cerene device provides gynecologists with the first realistic option for treatment in their office, a setting that is more comfortable for women and significantly less expensive for the healthcare system. The shift away from the operating room that the Cerene device enables could potentially reduce the cost to treat heavy menstrual bleeding by hundreds of millions of dollars annually.”

“Channel Medsystems has developed a treatment that is easy to use, is reproducible in any setting of care and is very well tolerated without anesthesia. The development of new technology like the Cerene device could allow gynecologists to provide a safe, effective, affordable and convenient treatment to the millions of women who seek care for heavy menstrual bleeding annually in the United States,” added study investigator Dr. Ted Anderson of Nashville’s Vanderbilt University Medical Center.

Channel Medsystems has raised at least $47.6 million in a series of funding rounds that included Boston Scientific (NYSE:BSX), which acquired a 20% stake for $20.6 million spread over two of the rounds. In November 2017 the companies agreed to a deal that would have seen Boston acquire the remaining 80% for $275 million if it won FDA approval by Sept. 30 of this year.

The agreement foundered in the wake of an alleged embezzlement scheme in which federal prosecutors indicted then-quality assurance VP Dinesh Shankar on six counts of mail fraud. Channel sued to enforce the buyout, claiming that Shankar’s theft didn’t affect Channel’s pivotal trial or impede its the PMA bid it filed last August. The case is still under way in a Delaware state court.

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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.

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Volpara expands distro deal with GE Healthcare

Volpara Solutions

Volpara Solutions said yesterday that it expanded its distribution agreement with GE Healthcare (NYSE:GE) to include the global distribution of its VolparaDensity software.

Wellington, New Zealand-based Volpara said that its VolparaDensity software is designed to analyze mammograms using machine learning to provide automated, objective and volumetric breast density assessments and a breast density category that correlates to BI-RADS 5th and 5th editions.

“There are still certain signs of breast cancer that are best seen on a mammogram, which is why the Invenia ABUS is used in addition to mammography. ABUS screening helps find cancers hiding in dense tissue. Accurate density measurements and quality imaging are very important in breast cancer detection. I encourage women to learn their breast density, understand their risk, and talk to their healthcare providers to get the personalized healthcare they need,” Dr. Joseph Russo of St. Luke’s University Health Network said in prepared remarks.

Volpara touted that the system has been the subject of more than 100 peer-reviewed papers and 250 publications, and said that it is currently

“We are excited to expand access to VolparaDensity as part of our product portfolio. Now, our customers outside the US will also have access to a proven technology that will help them identify women who may benefit from a supplemental screening modality, such as the Invenia ABUS,” GE Healthcare automated breast ultrasound GM Luke Delaney said in a prepared statement.

“We have had a very productive partnership with GE over the past several years. We are thrilled to expand our agreement beyond the US market, working with GE Healthcare to offer customers a well-researched and widely adopted breast density assessment tool to help them deliver excellent breast health care. Providing an accurate and consistent assessment of breast density is becoming increasingly important to identify women at high risk of developing breast cancer,” Volpara Solutions prez & CCO Mark Koeniguer said in a press release.

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FDA wants to update mammography standards

The FDA today issued a proposed rule that would modernize mammography quality standards and require mammography facilities to provide more information to patients and healthcare providers.

The proposed rule would be the first update in 20 years, amending regulations issued under the Mammography Quality Standards Act of 1992, which authorizes FDA oversight over mammography facilities, including their accreditation, certification, annual inspections and enforcement of standards. The new proposal could help patients and providers make more informed decisions regarding care, and boost the FDA’s regulatory power over the safety and quality of mammography services, the agency said.

The proposed amendments include:

  • Adding specific language about breast density to the mammography results summary letter provided to patients and to the medical report sent to providers.  Mammograms of breasts with a higher proportion of dense fibroglandular tissue compared to fatty tissue can be difficult to interpret because the dense tissue can obscure signs of breast cancer, lower the sensitivity of the image and increase the risk of developing breast cancer.
  • Codifying three more categories for mammogram assessment, including one titled “known biopsy-proven malignancy,” which would help identify for health care professionals cases in which cancer that is being evaluated by mammography for therapy has already been identified.
  • Adding more detailed information about the mammography facility to patient summaries and medical reports for caregivers to aid in post-exam communications.

Proposed changes to boost the FDA’s enforcement powers include:

  • Expressly stating that the FDA can directly notify patients and their health care professionals, should facilities be unwilling or unable to do so, that mammography at a facility did not meet quality standards and that reevaluation or repeat of the mammogram at another certified facility may be needed.
  • Requiring facilities to use only FDA-approved or -cleared digital accessory components for mammography, or that facilities use components that otherwise meet the requirements under the rule.
  • Strengthening record-keeping requirements to minimize information loss and improve access to and transfer of patient mammography records.

“As part of our overall commitment to protecting the health of women, we’re proposing new policies to modernize our oversight of mammography services, by capitalizing on a number of important advances in mammography, like the increased use of 3-D digital screening tools and the need for more uniform breast density reporting,” said FDA commissioner Dr. Scott Gottlieb in a prepared statement. “We’re committed to making sure patients have access to high-quality mammography. Today’s proposed rule would help to ensure patients continue to benefit from advances in new tools and robust oversight of this field.”

According to the National Cancer Institute (NCI), approximately 12.4% of women will be diagnosed with breast cancer at some point during their lifetime. NCI estimates that, in 2018, more than 260,000 women were diagnosed with breast cancer and more than 40,920 women died of the disease. Aside from skin cancer, breast cancer is the most common cancer among women and the second leading cause of death. Mammography can also be an important tool in detecting male breast cancers. According to the NCI, breast cancer may occur in men at any age, but usually occurs in men between 60-70 years of age.

“The FDA is committed to advancing efforts that improve the health of women,” said FDA principal deputy commissioner Dr. Amy Abernethy. “Given that more than half of women over the age of 40 in the U.S. have dense breasts, helping to ensure patient access to information about the impact that breast density and other factors can have on the risk for developing breast cancer is an important part of a comprehensive breast health strategy.”

The proposed rule may be found here and is available for public comment for 90 days from publication.

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