FDA: GE R860 ventilator safety guard recall is Class I

GE Healthcare

The FDA today labeled a select recall of GE Healthcare‘s (NYSE:GE) CareScape R860 inspiratory safety guards, designed for use with a ventilator, as Class I.

Class I designations, the FDA’s most severe classification, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.

The R860 inspiratory safety guard is a breathing accessory intended for use with the Carescape R860 ventilator, which is designed to provide mechanical ventilation and breathing support to patients.

The devices are being recalled due to a risk of the safety guard disconnecting from the patient’s breathing circuit due to a manufacturing defect that may cause the outlet connector to have incorrect dimensions. Affected devices may result in the device not having a secure fit with the breathing circuit, which may result in the patient not receiving breathing support, the federal watchdog said.

No patient injuries have been reported in relation to the issue, but “there remains a risk of ventilation and oxygen-loss (hypoxia) should the patient’s airway become disconnected from the breathing circuit,” the FDA wrote in its recall notice.

GE Healthcare began notifying customers of the issue in October, outlining instructions for identifying the error and instructing them to return or destroy any incorrect and affected unused guards.

The recall affects a total of 307 GE Healthcare CareScape R860 inspiratory safety guards in the US with model numbers 2066713-001 for single packs and 2083208-001 for boxes of ten single packs, and with lot numbers 17/00951, 17/01174, 17/01937, 17/01994, 17/02372, 17/02393, 18/00126, 18/00127, 18/00128, 18/00129, 18/00130, 17/00951, 17/01174, 17/01937, 17/01994, 17/02372, 17/02393, 18/00126, 18/00127, 18/00128, 18/00129 and 18/00130. The recall only affects devices manufactured and distributed between August 2017 and September 2018, according to the release.

In November, GE Healthcare said that it closed out a full field inspection of all of its Millenium MG, MC and Myosight nuclear medicine systems after an incident in which the system malfunctioned.

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Olympus wins FDA nod for Spiration bronchial valve

Olympus

Olympus (TYO:7733) said yesterday that it won FDA approval for its Spiration Valve System intended to treat severe emphysema, which was designated as a breakthrough medical device.

The Spiration Valve is an umbrella shaped device intended to improve breathing by blocking airflow to diseased portions of the lung, the Tokyo-based company said. The device is placed during a bronchoscopic procedure to reduce lung volume in diseased lung sections and allow healthier tissue in the remaining portion of the lung to function better.

Approval of the device came based on the results from the Emprove clinical trial of the SVS, which demonstrated that patients treated with the system showed statistically significant and clinically meaningful improvements in lung function and quality of life as compared to the standard of care.

Results also indicated a favorable risk benefit profile and a shortened procedure time, which Olympus said may reduce the risk of adverse events. Serious adverse events noted in the study included chronic obstructive pulmonary disorder exacerbations, air leaks, pneumonia and death.

“In the patients I treated in the Emprove trial, the most important outcome was a marked reduction in shortness of breath, or dyspnea. This resulted in improved quality of life and patient satisfaction. Dyspnea is the most common symptom in patients with advanced emphysema and severe hyperinflation, and is the most refractory to medical treatment,” Dr. Gerard Criner of the Lewis Katz School of Medicine at  Temple University said in a press release.

In October, Olympus said that it launched the Endoeye Flex 3D and FlexDex needle driver laparoscopic surgical tools in the U.S.

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Medtronic updates software for Puritan Bennett 980 ventilators in FDA-labeled Class I field action

Medtronic logo updated

Medtronic (NYSE:MDT) said this week that it released a software update for its Puritan Bennet 980 ventilators in a field action labeled by the FDA as Class I.

Class I designations, the FDA’s most serious classification, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.

The Puritan Bennett 980 is a mechanical ventilator intended for prescription use by trained professionals to support patient breathing, the Fridley, Minn.-based company said.

The software patch is intended to update the external USB drive performance and its impact on graphical user interface functionality, as well as the labeling displayed on the GUI during ventilator use. The update also includes product enhancements, Medtronic said.

Medtronic said that it also updated the PB980 operators manual with additional information, according to a press release.

The company said that the devices are still safe to use without the update, and that it has not received any confirmed reports of serious adverse health consequences related to the issue the patch is intended to address.

Also this week, Medtronic said that it agreed to pay $50.9 million to settle a number of U.S. Dept. of Justice probes into marketing activities from companies it acquired, including Covidien and ev3.

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Inspire Medical offers another 1.5 million shares following April IPO

Inspire Medical Systems (NYSE: INSP) is offering 1.5 million shares of common stock for sale to the public, and its stockholders are selling 1 million additional shares of the stock, according to a regulatory filing. The company hopes to make $66.8 million on the sale.

Maple Grove, Minn.-based Inspire, which spun out from Medtronic (NYSE:MDT) in 2007, makes devices for treating obstructive sleep apnea. The company had said it planned to issue 5 million shares at $14 to $16 apiece in its IPO in April 2018, but in May upped the offering to a least $108 million.

Inspire posted a net loss of $17.1 million for the nine months ended September 30, 2018 on sales of $34 million and a gross margin of 80%.  Those results compared to a net loss of $13.3 million on sales of $18.6 million and a gross margin of 78% for the same period last year. Its accumulated deficit as of September 30, 2018 was $142.1 million.

Inspire’s common stock closed at $47.89 per share on Dec. 3 and dropped to $42.95 at the opening today, bouncing back slightly to $45.25 by 11:30 a.m. EST. Inspire based the $66.8 million figure on selling the stock at $47.89 per share, which is the last reported sale price on December 3.

The company said it intends to use the net proceeds from the offering to hire additional sales and marketing personnel, expand marketing programs in the U.S., Europe and Japan, to fund product development and R&D, for working capital and other general corporate purposes. It might also use some of the proceeds to acquire, in-license or invest in products, technologies or businesses that are complementary to its business, but said it has no agreements or commitments to complete any such transaction.

Inspire said it will not receive any proceeds from the sale of its common stock by the selling stockholders in the offering.

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ResMed puts $225m on the table for Propeller Health

ResMed, Propeller HealthResMed (NYSE:RMD) said today that it inked a deal to acquire Propeller Health and its digital medicine platform for $225 million in cash.

Propeller Health, which sells small sensors that attach to inhalers and track medication use, will operate as a standalone business under ResMed’s respiratory care portfolio.

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

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Pulmatrix raises $3m in offering

PulmatrixPulmatrix (NSDQ:PULM) said this week that it inked a deal with an institutional investor to sell 9,375,000 shares of common stock at
32¢ apiece.

The Lexington, Mass.-based company expects to reel in $3 million in total gross proceeds from the offering.

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

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Propeller Health touts link between air pollution, rescue inhaler use in nationwide asthma study

Propeller Health

Propeller Health today touted results from a nationwide study that indicated a direct association between daily air pollution and rescue inhaler use.

Results from the study, which spanned five years and involved more than 2,800 individuals with asthma, were published in the Proceedings of the National Academy of Sciences, the Madison, Wisc.-based company said.

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

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Philips wins CE Mark for V60 Plus high flow ventilator

Philips

Royal Philips (NYSE:PHG) said today it won CE Mark approval in the European Union for its Philips V60 Plus ventilator system.

The Netherlands-based company said that the newly cleared system features both noninvasive ventilation and high flow therapy, which allows the system to be used with changing patient conditions without having to switch devices.

The V60 is intended for early interventions into respiratory failure, Philips said, but is designed to deliver a wide range of non-invasive support for patients to lessen the challenge of weaning patients off of noninvasive ventilation.

“When treating respiratory patients in intensive and emergency care settings, it’s critical for clinicians to be able to wean efficiently or to quickly escalate care depending on their patient’s condition and specific needs. This often means complex workflows and alternating devices in time-sensitive situations. We are excited to offer a comprehensive noninvasive solution that enables quick therapy and interface transitions, so clinicians can focus on providing for their patients while spending less time setting up equipment,” Philips hospital respiratory care biz lead Jim Alwan said in a prepared statement.

Philips said that it is also seeking FDA 510(k) clearance for the system, and that it has already submitted to the agency.

“We are delighted with the high flow function of the V60 Plus. It saves us a lot of time and space as we can use the same equipment for both NIV and high flow. When you need to wean patients from NIV to HFT, it is very simple with the one device. Additionally, the cannula is high quality, easy to adjust, soft against the patient’s skin and V60 flow is much quieter than our standalone high flow system,” registered nurse Peter Lindberg of Stockholm, Sweden’s St. Goran Hospital said in a press release.

Last month, Philips said that it launched an all-in-one breast assessment solution designed for use with its Epiq and Affiniti ultrasound systems.

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Vapotherm closes $64m IPO

Vapotherm

Vapotherm said today it closed its initial public offering, raising a total $64.4 million in gross proceeds.

The Exeter, N.H.-based company developed the Precision Flow line of devices to provide high-velocity heated, humidified and oxygenated air to treat patients with conditions such as pneumonia, chronic obstructive pulmonary disease, asthma and heart failure. Some 1,200 of the devices have been sold in the U.S., mostly into hospital ICUs, the company said.

Vapotherm said it floated 4.6 million shares of its common stock at $14 per share, and that the offering featured a fully exercised underwriter’s option to purchase an additional 600,000 shares of common stock.

The company said that shares began trading on the NYSE under the ticker symbol “VAPO” on Wednesday, according to a press release.

Proceeds from the flotation are earmarked for expanding its sales and marketing teams and increase its marketing footprint in the U.S. and overseas, the company has said. Some of the cash will also go toward R&D, working capital and general expenses, according to a regulatory filing.

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Pulmonx wins Aetna coverage for Zephyr endobronchial valve

Pulmonx

Pulmonx said yesterday that it won national coverage through health insurer Aetna for its Zephyr endobronchial valve system intended for treating severe emphysema and chronic obstructive pulmonary disorder.

The coverage will make the Zephyr valve available to Aetna’s 22 million members, the Redwood City, Calif.-based company said.

Under its new policy, Aetna specifically named the Zephyr as an approved bronchoscopic option for lung volume reduction, considering it medically necessary for the broncoscopic treatment of adult patients with hyperinflation associated with severe emphysema in regions of the lung with little or no collateral ventilation, Pulmonx said.

“Zephyr Valves are a major step forward in treating severe emphysema and it is very exciting to see a large health plan like Aetna offer coverage to its members. This coverage gives patients access to a new treatment that can improve their lives long term without the risk of major surgery. Patients with severe emphysema often suffer with poor breathing and mobility. As a physician who cares for patients with COPD, I am looking forward to being able to offer a minimally invasive treatment to patients that can help them breathe easier and get back to living a more active life,” Dr. MeiLan Han of the University of Michigan said in a prepared statement.

The valve is implanted in a bronchoscopic procedure that requires no cutting or incisions, the company said. During the procedure, an average of four valves are placed in the airways to block off the diseased sections of the lungs to allow air to escape until the lobe reduces in size.

Pulmonx said that reducing hyperinflation and preventing air from getting trapped in the diseased areas of the lung allows healthier areas of the lungs to expand and take in more air, letting patients breathe more easily and have less shortness of breath.

“Patients with severe emphysema need new treatment options. The Zephyr Valve has been shown in four consecutive published clinical trials to improve the pulmonary function, exercise capacity, and quality of life of these patients which led FDA to designate the Zephyr Valve a ‘breakthrough device.’ Aetna’s coverage policy is serving its members well by making this well-proven new treatment available to them,” prez & CEO Glen French said in a press release.

In June, Pulmonx won pre-market approval under the FDA’s breakthrough device designation for the Zephyr valve.

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