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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Wireless preemie monitoring system allows more parental contact

A tiny participant in the Northwestern University study of a wireless NICU monitoring system. (Image courtesy of Science, per a Creative Commons 4.0 license)

A new, less invasive system for monitoring preterm and critically ill newborns’ vital signs would allow parents skin-to-skin contact with their babies when they otherwise couldn’t have it.

The system, designed by researchers at Northwestern University in Chicago, uses ultrathin, skin-like electronic sensing technology to overcome the limitations of traditional systems that require a large number of wired sensors. The researchers developed a pair of sensors that only require water to adhere to a newborn’s fragile skin and allow for untethered monitoring of key vital signs and can streaming data wirelessly it in real time to external devices.

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Abbott wins FDA approval for Amplatzer Piccolo occluder for neonates

AbbottThe FDA granted pre-market approval for the Amplatzer Piccolo occluder made by Abbott (NYSE:ABT) to treat a congenital heart defect in neonatal infants as small as two pounds, the company said today.

The Chicago-area healthcare giant said Amplatzer Piccolo is a transcatheter, self-expanding, wire mesh device that’s inserted via the aortic or pulmonary artery to close a hole in the heart known as patent ductus arteriosus.

“Piccolo is a critical advancement in the standard of care for the most vulnerable of premature babies who may not be able to undergo surgery to repair their hearts,” structural heart VP Michael Dale said in prepared remarks. “Our mission is to develop life-changing technology to help people live better lives through improved health. This approval is another important step toward achieving our mission for the patients and physicians we serve.”

“This approval is a potentially life-saving advance for the very smallest premature infants that will help us treat these delicate babies who might otherwise not be able to survive,” added Dr. Evan Zahn, of the Cedars-Sinai’s Smidt Heart Institute Los Angeles, who was principal investigator for the Amplatzer Piccolo pivotal trial.

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Empatica’s pediatric seizure-predicting smartband wins FDA nod


Empatica’s Embrace smartband for pediatrics

Empatica said that its Embrace epilepsy smartband has received 510(k) clearance from FDA for use in children, a year after winning clearance for adults with epilepsy.

Embrace was designed to detect motion patterns and physiological signals that may be associated with generalized tonic-clonic (“grand mal”) seizures and immediately alert caregivers. It is the first non-EEG based, physiology-signal seizure monitoring system that FDA has cleared for use in a pediatric population, according to the Cambridge, Mass. company.

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FDA green-lights pediatric indication for Paragonix’s SherpaPak heart transport device

Paragonix Technologies said today that the FDA granted 510(k) clearance for a design change to its SherpaPak heart transport device so that it can be used with small and pediatric hearts.

Braintree, Mass.-based Paragonix said it will begin shipping heart connectors covering most aortic diameters during the first quarter of 2019.

“This FDA clearance is an important milestone in making the Paragonix SherpaPak CTS accessible for all donor populations, increasing the market reach of this important transplant product,” chairman & CEO Bill Edelman said in prepared remarks. “Our goal is to establish a new standard of care for donor organ preservation and with our FDA cleared and CE marked devices for both heart and kidney organ stage and transport, we are on our way to make this a reality.”

Paragonix won won 510(k) clearance from the FDA in December 2014 for the SherpaPak heart device and landed CE Mark approval in the European Union in February.

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OrthoPediatrics announces pricing of common stock offering

OrthoPediatricsOrthoPediatrics (NSDQ:KIDS) said today it will price an underwritten follow-on public offering of 1.5 million shares of its common stock at $27 per share.

The company said it plans to use the proceeds of offering to invest in implant and instrument sets for consignment to its customers, fund research and development activities, expand its sales and marketing programs and working capital and general corporate purposes.

The offering is expected to close on or around December 11, 2018, according to a regulatory filing. The Warsaw, Ind. company has also granted the underwriters a 30-day option to purchase up to an additional 225,000 shares of its common stock at the public offering price.

In May, OrthoPediatrics won FDA 510(k) clearance for its Femur pediatric nailing platform. The company’s Femur system is designed to accompany two pediatric-specific nail offerings and is an upgrade to an earlier version of the device. OrthoPediatrics said the clearance of the device is the “next step” in the evolution of its intramedullary nailing franchise.

The company’s shares opened at $27.25 today, and had climbed to $30 by noon Eastern time.



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Vapotherm touts automated oxygen controller in preemie study

VapothermA recent clinical trial showed that Vapotherm’s (NYSE: VAPO) new IntellO2 module for its Precision Flow system greatly improved the chances of keeping premature babies in the target oxygenation range.

The prospective, multi-center, controlled, order-randomized crossover trial demonstrated that using the IntellO2 module helped clinicians maintain newborns in the physician-prescribed oxygen saturation range 80% of the time, compared with 49 % for manual control alone, the company said in a statement. The study was published in the Archives of Disease in Childhood: Fetal and Neonatal Edition.

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Wishbone Medical picks up pediatric device maker Response Ortho

WishBone Medical acquires Response OrthoWishBone Medical said this week that it acquired Turkish pediatric fixation device maker Response Ortho for an undisclosed amount.

Istanbul-based Response’s portfolio includes 30 pediatric orthopedic systems; WishBone had eight before the acquisition, the Warsaw, Ind.-based company said.

Eighteen of the Response Ortho products are cleared or approved for the U.S. market. Wishbone said it’s opursuing 501(k) clearance for the others.

“With the acquisition of Response Ortho, we are thrilled about our pediatric orthopedic product offerings. The combination of Response Ortho’s thirty product systems and WishBone’s eight product systems will give WishBone Medical the broadest product portfolio in pediatric orthopedics worldwide,” founder, chairman & CEO Nick Deeter, who also founded OrthoPediatrics, said in prepared remarks. “These pediatric orthopedic products can be delivered in sterile packed, procedural kits anywhere in the world, next day, to the surgeons that care for children.”

“We are excited that Response Ortho is now part of WishBone Medical. Our primary focus has been outside the U.S., and we will now be able to offer these innovative orthopedic product systems everywhere. Having more than 50 years of combined experience, Nick and I understand the unmet needs and will provide global solutions to children with orthopedic issues,” added Response Ortho CEO Sehmuz Isin.

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Natus takes a hit on Q3 misses

Natus MedicalInvestors pushed share prices down today for Natus Medical (NSDQ:BABY) after the neonatal care company missed expectations with its third-quarter results.

Pleasanton, Calif.-based Natus pared its losses by -34.5% to -$5.6 million, or -17¢ per share, on sales growth of 6.5% to $130.6 million for the three months ended Sept. 30, compared with Q3 2017.

Adjusted to exclude one-time items, earnings per share were 40¢, 2¢ below the consensus forecast on Wall Street, where analysts were looking for sales of $132.9 million.

“Our 2018 third-quarter results are highlighted by 6.5% year-over-year revenue growth and 12.1% growth in non-GAAP operating income driven both by the acquisition of our neurosurgery business last year and modest organic growth in neuro,” president & CEO Jonathan Kennedy said in prepared remarks. “We also continued to make progress on the regulatory front, successfully completing an FDA audit and our first MDSAP audit in our Seattle facility during the quarter.”

Natus cut its earnings outlook for 2018, saying it now expects to report adjusted EPS of $1.47 to $1.50, down from from $1.50 to $1.60 previously, and lowered the top end of its revenue guidance to $525.0 million to $530.0 million, compared with $525.0 million to $535.0 million previously.

Fourth-quarter adjusted EPS are forecast to be 48¢ to 51¢ on sales of $135.0 million to $140.0 million; analysts on The Street are looking for adjusted EPS of 54¢ on $138.0 million in sales.

BABY shares were off by -1.1% at $30.82 apiece today in early trading.

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Report: FDA’s Gottlieb says pediatric device approvals are lagging

FDA head Scott Gottlieb said that over the past 10 years there have been “far too few” devices hitting the US market designed specifically for a pediatric population, according to a recently posted Regulatory Affairs Professionals report.

The statement came at a two-day FDA workshop this week, according to the report.

Barriers including sample size issues, regulatory concerns and problems with research infrastructure are keeping such devices from hitting the market, according to an audience poll from the workshop.

While the number for adult devices approved by the FDA grew at a rate of 3.8 per year between 2008 and 2017, pediatric devices grew at a much smaller rate of approximately 1 per year, according to RAPS.

The same trend is reflected in other submissions, including de novo and humanitarian device exemptions for pediatric patients, according to the report.

The FDA has launched initiatives looking to support development in the pediatric space, including a new division on pediatric internal medicine for drugs, according to the report. The agency is also “looking for new ways to protect children who participate in clinical trials,” Gottlieb said, according to RAPS.

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