Getinge shares jump on FDA deal

February 4, 2015 By Brad Perriello Leave a Comment

Getinge (PINK:GETI B) today inked a deal with the FDA to fix manufacturing problems that led to a string of warnings from the federal safety watchdog.

The Swedish medical device giant signed a consent decree with the FDA’s Center for Devices & Radiological Health that means a temporary halt for some products made at its Atrium Medical operation in Hudson, N.H., according to the company and court documents, although Atrium can continue making products deemed "medically necessary" by the FDA. The closure is expected to hit Getinge’s operating profits by about $61 million, or 500 million kroner, the company confirmed today.

"Patients must be assured that medical devices are safe, effective and high quality," acting director of CDRH’s Office of Compliance Jan Welch said in a statement. "The FDA will remain vigilant in bringing companies that do not meet our regulatory requirements back to a sustainable state of compliance."

The ruling means Atrium’s ProLite, ProLoop and C-QUR hernia meshes, its Flixene vascular graft and its Ivena vascular patch will be off the market until the issues are resolved, the FDA said.

“We have learned from this experience, and this agreement with the FDA provides us with a clear path forward," CEO Johan Malmquist said in prepared remarks. "We have taken this situation very seriously and have committed substantial investments into the quality management system. The remediation work is well underway and has already led to significant improvements."

News of the consent decree sent Getinge shares up 3.6% to about $28.38 (219.50 kr) in early trading today. Getinge acquired Atrium in 2011 for $680 million.

The settlement stems from FDA inspections in 2012 and 2013 at Atrium’s Granite State facilities and at plants in Wayne, N.J., and in Hechingen and Rastatt, Germany, according to filings with the U.S. District Court for New Hampshire. Inspections at the Atrium plant in 2013, after an October 2012 warning letter, still found problems, according to the filings.

Inspections at the New Jersey plant during the same period in 2013, following warning letters in 2010, also turned up violations, as did FDA inspections in Hechingen and Rastatt during September 2013. The German plant inspections resulted in Form 483 warnings to Maquet, according to the filings.

Maquet Cardiovascular is still facing a warning letter issued Dec. 4, 2014, for marketing its CardioHelp extracorporeal membrane oxygenation without pre-market approval from the FDA. The agency requested that CardioHelp, which was cleared via 510(k) in 2011, be taken off the U.S. market until its PMA requirements are met.

New 510(k) boosts iRhythm, Verily efforts for AFib screening
The latest 510(k) clearance for the Verily Study Watch will further the efforts of the Google sister company and iRhythm Technologies (NSDQ:IRTC) to improve atrial fibrillation treatment. Verily — a life science company under Alphabet (NSDQ:GOOGL) — recently received an FDA 510(k) clearance to include an irregular pulse monitor in its Study Watch wearable. “We’ve worked carefully to meet the FDA’s stringent… […]
Argon Medical debuts IVC filter retrieval kits
Argon Medical Devices (Frisco, Texas) said this week that it has launched single-loop and triple-loop retrieval kits for percutaneous removal of inferior vena cava (IVC) filters that are no longer medically required. The kits are indicated for use via a jugular approach and offer the following features: A coil-reinforced outer sheath with the strength needed… […]
NANS 2020: Neuromodulation news you need to know
Neuromodulation devices from companies including Medtronic (NYSE:MDT), Abbott (NYSE:ABT) and SPR Therapeutics are showing promise treating pain. That’s one of the initial takeaways from study results that medical device companies in the neuromodulation space are touting this weekend at NANS 2020 in Las Vegas. NANS is a joint conference of Congress of Neurological Surgeons and the North American Neuromodulation… […]
Injection Molding Principles
Optimizing custom part designs for injection molding requires a thorough understanding of the process and outcomes. In this e-book, you’ll learn about common molding resins, special molding terms you should know, and most importantly, how to optimize your part with undercuts, even walls, drafts, and more. Download this e-book from Xometry to learn more… The […]
GW Plastics expands Vermont manufacturing and tech center
GW Plastics announced that it has completed a $10 million expansion of its Royalton, Vt., manufacturing and technology center. The company said it has added a 30,000 ft2 to the building to accommodate the growth of its thermoplastic injection molding and medical device contract assembly business. The expansion includes a new 13,000 ft2, Class 8… […]
Certain GE Healthcare patient-monitoring devices vulnerable to cyberattack
The federal government and GE Healthcare (NYSE:GE) announced today that the certain of the company’s patient monitoring devices are vulnerable to cyberattack. If attacked, some versions of the Carescape and ApexPro telemetry servers, the Carescape Central Station version 1 and Central Information Center systems could stop monitoring patients, silence alarms or produce unnecessary alarms during… […]
Cardinal Health recalls 9 million surgical gowns, sends hospitals scrambling
Cardinal Health (NYSE:CAH) announced that it is voluntarily recalling 9.1 million surgical gowns produced by an unnamed contract manufacturer after discovering quality issues with the product. The Dublin, Ohio-based company said that some gowns were produced in unapproved locations that did not maintain proper environmental conditions as required by law. Some of the gowns were also… […]
KNF launches compact swing piston pump
KNF Neuberger is touting its NPK 06 swing piston micro gas pumps, designed to deliver high-flow and high-pressure performance in a compact size. The new pumps work well for medical diagnostics, therapy, monitoring, and general compression applications, according to the Trenton, N.J.-based company. NPK 06 measures 1.85” (47mm) wide and can produce free flow up… […]
Heraeus Medical Components and Myant partner on electrical sensing for textiles
Heraeus Medical Components (St. Paul, Minn.) and Toronto-based Myant have entered a partnership enabling Myant to use Heraeus’ Tectitoat for electrical sensing applications in textiles, the companies announced today. Tecticoat is a conductive polymer-based coating that can be applied to textiles to control electrical conductivity, electromagnetic shielding and electrostatic dissipation, making it suitable for integration… […]
Cook Medical’s peripheral artery set debuts in U.S.
Cook Medical recently announced the U.S. launch of its TriForce peripheral crossing set to support vascular obstruction procedures. The TriForce set is designed to be percutaneously introduced into blood vessels to support a wire guide while performing a peripheral intervention, according to the Bloomington, Ind.-based company. This device is also intended for injection of radiopaque… […]
Bayer and Exscientia partner to bring AI to drug discovery
Bayer (ETR:BAYN) announced that it is entering into a collaboration agreement with artificial intelligence drug discovery company Exscientia to identify and optimize novel lead structures for potential drug candidates in treating cardiovascular and oncological diseases. The agreement, announced earlier this month, is slated to see the companies work together on early research projects combining Exscientia’s proprietary… […]