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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EO plant shutdown leads to pediatric breathing tube shortage

Smiths Medical Bivona tracheostomy tubes are in short supply, according to the FDA. (Image from Smiths Medical)

The February shutdown of an ethylene oxide (EO) sterilization plant has produced the first temporary medical device shortage, according to the FDA.

The device in short supply is the Bivona tracheostomy tube manufactured by Smiths Medical and used by many pediatric patients. The FDA anticipates the tube will be made available again the week of April 22, according to a statement from Dr. Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health (CDRH). The state of Illinois ordered the shutdown of the Sterigenics plant in Willowbrook, Ill. due to emissions of EO, a highly carcinogenic chemical compound.

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Bedfont wins FDA nod for ToxCO carbon monoxide monitor


British medical device firm Bedfont said today that it won FDA 510(k) clearance for its ToxCO breath analysis monitor designed to measure exhaled carbon monoxide to indicate levels of CO in the blood.

The newly cleared system is intended for use in triaging cases of CO poisoning as it provides instant results at the point-of-care, the Maidstone, UK-based company said.

Samples can be taken via a low-cost mouth piece or a face mask option for patients who are either unconscious or injured, the company said. The system also automatically samples the ambient air and alarms when CO in the environment reaches a harmful level.

“Not only can our breath analysis monitor help to evaluate patients quickly and effectively for CO poisoning, but it can also reduce emergency department visits and hospitalizations. We are thrilled with the FDA approval of the ToxCO; we believe it will be game-changer for healthcare personnel in America,” managing director Jason Smith said in a press release.

Bedfont said that it has already inked an exclusive U.S. distribution deal with CoVita.

“The ToxCO will be a useful tool for healthcare professionals such as paramedics in Firefighter Rehab. We believe it will fundamentally change how people are assessed for CO poisoning in the United States,” CoVita prez Jason Aversano said in a prepared statement.

Breath Therapeutics launches Ph3 trial for inhaled liposomal cyclosporine A therapy

Breath Therapeutics logoPrivately-held Breath Therapeutics said today that it kicked off a Phase III clinical program for its liposomal formulation of cyclosporine A for the treatment of bronchiolitis obliterans syndrome.

The company’s primary drug candidate, L-CsA-i, is an inhaled therapy delivered via Pari Pharma‘s investigational eFlow nebulizer.

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


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Novartis launches COPD inhalers in China

NovartisNovartis (NYSE:NVS) has launched its Ultibro Breezhaler and Seebri Breezhaler in China for the treatment of chronic obstructive pulmonary disease.

The Ultibro Breezhaler system is a once-daily fixed-dose combination of indacaterol and glycopyrronium bromide. Seebri Breezhaler is a fixed-dose formulation of glycopyrronium bromide.

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

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Philips touts adaptive servo ventilation sleep apnea study data


Royal Philips (NYSE:PHG) yesterday released results from a study exploring the use of adaptive servo ventilation in treating patients with complex sleep apnea.

Results from the study were published in the American Journal of Respiratory and Critical Care Medicine, the Amsterdam-based company said.

Investigators in the study compared the performance of four different ASV devices, including Philips’ DreamStation BiPap autoSV, as well as an ASV device originally associated with greater mortality during the SERVE-HF trial published in 2015, the company said.

“The pursuit for scientific understanding of various disease and treatment processes is an iterative process where we revisit successes and failures to deepen our understanding of disease processes. It’s imperative we keep this in mind and re-visit previous studies when technological advancements show promise for a certain type of therapy. Today, ASV isn’t used in certain clinical settings due to safety concerns associated with the therapy in patients with congestive heart failure and predominantly central sleep apnea. Now, through devices with smarter algorithms, providers can potentially ensure that patients are getting the right treatment and thereby improve treatment approaches in patients with complex or central sleep apnea,” lead study investigator Dr. Sairam Parthasarathy of the University of Arizona College of Medicine said in a prepared statement.

Data from the new trial suggests that certain physiological performances were different across different devices, and that the mechanisms underlying adverse effects of ASV may be secondary to excessive ventilation due to device-based effect rather than a class-effect, Philips said.

“Philips provides healthcare professionals and patients with innovative treatment solutions and services. The safety of patients who use our devices is our top priority. We also wish to maximize the benefits that patients receive from using our technology. As a science company, we are obligated to understand why and how ASV in the SERVE-HF trial can be associated with increased risk of mortality in patients with central sleep apnea and severe heart failure. Future research is needed to confirm if excessive ventilation during wakefulness and sleep due to device-specific ASV algorithms can result in potentially life-threatening consequences, especially in patients with heart failure,” Philips chief medical liaison Dr. Teofilo Lee-Chiong said in a press release.

Earlier this month, Carestream Health said that it agreed to deal its imaging IT business to Philips for an undisclosed amount.

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ResMed buys Korean home healthcare supplier HB Healthcare

ResMedResMed (NYSE:RMD) said today that it bought Korean home healthcare equipment supplier HB Healthcare for an undisclosed amount.

San Diego-based ResMed said the acquisition is aimed at extending its decade-old footprint in South Korea to “millions more patients through HBH and its wider network of trusted distributor partners.”

“ResMed has reaffirmed its leading role in Korea’s CPAP and respiratory care market, and commitment to improving millions of Koreans’ breathing and quality of life,” Resmed Korea sales & marketing director Kim Ho Kyun said in prepared remarks. “With HBH and our valued distribution partners in Korea, ResMed can maximize the number of people who can enjoy the benefits of life-changing cloud-connected sleep and respiratory therapy.”

“We’re excited to join the ResMed family and, together, help provide life-changing, cloud-connectable devices to millions of Koreans living with sleep apnea, COPD and other chronic diseases,” added HB Healthcare patient management director Hong Seung Chul.

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Propeller Health study suggests 84% of asthma inhaler use performed incorrectly

ResMed, Propeller Health

ResMed (NYSE:RMD) subsidiary Propeller Health today released results from a new study exploring real-world use of rescue or controller inhalers that indicated that the majority of users did not use their inhalers properly.

Results from the research were published in The Journal of Allergy and Clinical Immunology: In Practice, the Madison, Wisc.-based company said.

Read the whole story on our sister site, Drug Delivery Business News

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ARS Pharmaceuticals wins fast track status for epinephrine nasal spray

ARS PharmaceuticalsARS Pharmaceuticals said this week that it won fast track status from the FDA for its investigational intranasal epinephrine spray, ARS-1.

The San Diego, Calif.-based company’s device is designed to be an easy-to-use treatment for people suffering from severe allergic reactions to food, drugs and insect bites.

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

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Medtronic risk prediction tool could help prevent opioid deaths: Here’s how

Medtronic logo updatedMedtronic officials continue to hone their arguments for how the company’s capnography and oximetry systems could reduce potentially deadly opioid-induced respiratory compromise.

The medical device giant on Feb. 17 announced preliminary results of its Prodigy study, in which the company’s Microstream and Nellcor monitoring technology provided continuous capnography and oximetry for 1,496 patients across 16 sites in the U.S., Europe and Asia.

The study resulted in what Medtronic says is an easy-to-use risk prediction tool. Called the Prodigy score, it helps identify patients on the hospital general care floor who are taking opioid medications and are at high risk of developing a respiratory compromise.

The score takes into account variables including age, gender, sleep disorders, chronic heart failure and opioid naïvety. During the Prodigy study, it identified more than three-fourths of patients with confirmed respiratory depression.

Overall, opioid-induced respiratory depression occurred in nearly half of the patients in the study.

“Clinical evidence shows that acute and unexpected respiratory compromise on the general care floor is increasingly common. Until now, we have not been successful in predicting which patients are at high risk when recovering on the general care floor,” said Dr. Ashish Khanna, the primary study investigator and an associate professor of anesthesiology and intensivist at the Wake Forest School of Medicine.

“These data validate an easy-to-use [opioid-induced respiratory depression] risk prediction tool to identify patients at the highest risk and guide early intervention using continuous capnography-based monitoring. Early identification and intervention in these high-risk patients has the potential to improve patient safety and decrease the economic and clinical burden of unplanned ICU admissions,” Khanna said in a news release.

Opioid-induced respiratory depression is a “common, costly and deadly but preventable condition,” and Medtronic through the Prodigy study is committed to help, said Vafa Jamali, SVP and president of the Medtronic’s respiratory, gastrointestinal and informatics business.

“We are encouraged by the data demonstrating the use of the Prodigy OIRD risk prediction tool,” Jamali said. “It can help clinicians prioritize resources by identifying those patients at highest risk on the general care floor who should be continuously monitored with capnography and pulse oximetry.”



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