Getinge Archives - Medical Design Sourcing

FDA clears Getinge’s cardiovascular surgery offering, company lanches new table, light in U.S.

The Maquet Corin OR table. [Image courtesy of Getinge]Getinge this week announced a major FDA clearance and the beginning of a U.S. launch of multiple surgical tools.

The Gothenburg, Sweden-based company won 510(k) clearance for its Vasoview Hemopro 3. This adds to the company’s portfolio of endoscopic vessel harvesting (EVH) solutions.

Getinge said it designed the system with customer centricity top-of-mind. It hopes to offer enhanced procedural efficiency with the upcoming launch of this product, according to a news release. The company anticipates a U.S. launch in the third quarter of 2024. Submissions for approval in other key markets remains in progress.

Advanced features include enhanced smoke evacuation, regulated energy control, ergonomic game controller-style handle and an integrated cable.

“EVH is a therapy significantly helping patients towards faster recovery by minimizing surgical trauma and reducing post-operative pain. By o…

Getinge appoints Agneta Palmér as CFO

Agneta Palmér [Image courtesy of Getinge]Getinge announced today that it appointed Agneta Palmér as chief financial officer.

Palmér will succeed Lars Sandström, who is leaving Getinge for a new opportunity outside of the company. Palmér most recently was the EVP of operations services at Getinge and has been with the company since 2018.

”I am very pleased that Agneta is taking over as CFO. She has extensive experience from finance in global operations and has in-depth knowledge of Getinge’s business. In addition, in her previous role, she has been involved in establishing our current finance organization, which she will now continue to develop,” Getinge President and CEO Mattias Perjos said in a news release.

Before becoming EVP of operations services, Palmér was VP of corporate control at Getinge. She held similar roles at AB Volvo.

Her appointment takes effect at the end of March when Sandström steps down.

”Lars has contributed …

Getinge makes infection prevention play with Healthmark buy

Getinge announced today that it has acquired Healthmark Industries, a Fraser, Michigan–based provider of instrument care and infection control consumables.

The Swedish medtech company paid $320 million in cash for 100% of Healthmark.

The acquisition aims to bolster Getinge’s footprint in the U.S. sterile reprocessing market while paving the way for Healthmark’s global expansion. The field is more important than ever: In the U.S. alone, there are more than 2.8 million antimicrobial-resistant infections and 35,000 resulting deaths annually, according to the CDC.

“Together, we will offer a broad range of solutions to sterile processing departments in hospitals,” Stéphane Le Roy, president Surgical Workflows at Getinge, said in a news release.

“Healthmark’s position in the field of consumables for cleaning verification and packaging will be an ideal complement to our consumables, reprocessing capital equipment, and software solutions…

Getinge subsidiary Datascope has another serious intra-aortic balloon pump recall

The Cardiosave Hybrid system. [Image from FDA]The FDA issued a notice labeling another recall of Getinge subsidiary Datascope’s Cardiosave pump as Class I, the most serious kind.

This recall relates to the Swedish medtech company’s Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pumps (IABPs). Both devices were subject to two separate Class I recalls in March. The company also initiated a Class I recall for the systems in December 2021.

Datascope/Maquet/Getinge recalled the IABPs due to the potential to shut down unexpectedly. This occurs because of electrical failures in the power management board or solenoid board (power source path). Using an affected pump could cause serious adverse health events, including unstable blood pressure, injury and death.

The recall affects 4,586 devices in the U.S. Datascope/Maquet/Getinge reported 26 complaints with no reports of injuries or death related to the issue. The company and its subsidiaries dis…

FDA clears non-invasive mechanical ventilator from Getinge

The Servo-Air Lite ventilator. [Image courtesy of Getinge]Getinge announced today that the FDA cleared its Servo-air Lite wall gas-independent, non-invasive mechanical ventilator.

Gothenburg, Sweden-based Getinge designed the turbine-driven ventilator to offer ICU-quality ventilation. However, its non-invasive nature gears it more toward spontaneously breathing patients in need of extra breathing support.

The ventilator features a powerful turbine and long-lasting battery backup power. Getinge said in a news release that it can operate independent of wall gas with suitability for intrahospital transports.

Additionally, the system offers embedded workflows, support for High Flow therapy and a CO2 monitoring option. It features tools capable of supporting the escalation of therapy if necessary, too, Getinge said.

The company plans to make the product available for U.S. customers beginning in September 2023.

“We are happy to broaden our ven…

Getinge to acquire High Purity New England for up to $290M

Getinge announces today that it will purchase High Purity New England, a Smithfield, Rhode Island–based provider of custom single-use products for bioprocessing applications.

The Sweden-based life sciences giant will pay SEK 1.3 billion ($120 million)for all of privately-held High Purity New England’s outstanding shares at closing. In addition, there could be a maximum earn out of approximately SEK 1.85 billion ($170 million) in 2024–2026 if agreed net revenue performance milestones are achieved in 2023–2025.

Getinge expects the deal to close in Q3 2023, subject to customary consents, closing and regulatory conditions.

“This acquisition is another step in Getinge Life Science’s strategic journey to further expand our presence in the biopharma segment,” Eric Honroth, president of Life Science at Getinge, said in a news release. “High Purity New England (HPNE) has in recent years successfully supplied the industry with d…

Getinge’s Datascope has another serious intra-aortic balloon pump recall

The Cardiosave Hybrid system. [Image from FDA]The FDA issued a notice determining a recall of Getinge subsidiary Datascope’s Cardiosave intra-aortic balloon pumps (IABPs) as Class I, the most serious kind.

This recall relates to the Swedish medtech company’s Cardiosave Hybrid and Cardiosave Rescue IABPs. Both devices were subject to a separate recall that the FDA determined was Class I in December 2021.

Getinge’s Datascope subsidiary initiated their latest recall of an estimated 2,300 devices on Jan. 9, 2023. They distributed affected devices between March 6, 2012 and July 20, 2017, according to an FDA notice.

To date, Getinge received 44 complaints related to the latest issue with no reported injury or death.

Get the full story at our sister site, Medical Tubing & Extrusion.

Getinge acquires Ultra Clean Systems for $16M

Swedish medtech company Getinge announced today that it will pay SEK 170 million ($16 million) to acquire Ultra Clean Systems and its ultrasonic cleaning tech.

Getinge has already been the exclusive North American distributor of Tampa, Florida–based Ultra Clean Systems’ offerings for nearly a decade. Health providers use ultrasonic cleaning tech in hospitals and surgery centers to decontaminate surgical instruments.

In fact, ultrasonic cleaning is an integral part of best practices to reprocess instruments, especially the most complex ones used for robotic surgery, according to the company.

“With the addition of Ultra Clean’s expertise and technology, we significantly expand our offering to sterile reprocessing departments in North America, which now contains a complete range of process equipment, consumables and IT solutions,” Stéphane Le Roy, president of Surgical Workflows at Getinge, said in a news release.

“Getinge’s global sales reach …

Getinge launches new ventilator

The Servo-c ventilator. [Image courtesy of Getinge]Getinge this week launched its new Servo-c mechanical ventilator that offers lung-protective therapeutic tools for pediatric and adult patients.

The company aims for Servo-c to make healthcare accessible and affordable for more hospitals, according to a news release. Its design simplifies respiratory support, Getinge said.

“Lung protection challenges come in many shapes and sizes,” said Getinge President of Acute Care Therapies Elin Frostehav. “That is why Servo-c is designed for safe, easy and efficient use that enables personalized respiratory treatments. With the essential functionalities provided, it is ideal for hospitals in the targeted markets looking for a high acuity ventilator at an affordable price point.”

Servo-c uses modular component parts to enable smart fleet management. This ensures uptime and drives down costs without the need of proprietary disposables.

Other feat…

MDR reportedly causing medtech companies to leave EU market

The EU’s new Medical Devices Regulation (MDR) has created enough compliance costs that some medtech companies have stopped selling there., according to a report from Reuters.

Reuters spoke with eight companies, including the Swedish medtech giant Getinge, who are either withdrawing from the EU market or have stopped making medical devices. The costs of complying with the MDR were simply too much.

The EU’s MDR went into effect in 2021. Medical device makers have had until 2024 to transition previously certified devices to the new standard.

Reuters reports that European doctors’ groups are already reporting medical equipment shortages. The Russia-Ukraine war has caused material shortages that have further exacerbated the problem.

EU leaders have become aware of the problems. The EU Health Commissioner Stella Kyriakides has proposed extending the transition deadline to 2027 for high-risk devices — 2028 for medium- and low-risk produ…

Boston Scientific veteran is joining Getinge

Joanna Engelke, Getinge’s incoming EVP of quality compliance, regulatory & medical affairs [Image courtesy of Engelke]Getinge today announced a new EVP of quality compliance, regulatory & medical affairs.

Joanna Engelke will also join the Gothenburg, Sweden–based company’s executive team. Her experience includes a decade at Boston Scientific, with her final four years spent as the company’s SVP of global quality and regulatory.

Engelke most recently was chief quality officer at the electronic cigarette company Juul Labs. The FDA in June ordered the company to stop selling its e-cigarettes.

Getinge said Engelke will join the company on Oct. 6. She replaces Lena Hagman, who has decided to leave the company.

More about Getinge

Getinge provides a wide range of products and services to hospitals and life science researchers. It employs more than 10,000 people in 38 countries.

The COVID-19 pandemic had a major impact on thi…

Getinge partners with Medtronic to make Radiant balloon-expandable covered stent

The Radiant balloon-expandable covered stent created by Medtronic and Getinge [Image from Medtronic]Getinge announced today announced a partnership with Medtronic (NYSE:MDT) over the Radiant balloon-expandable stent, which received CE mark.

Radiant is designed for use in chimney endovascular aneurysm repair (ChEVAR) with the Endurant II/IIs stent graft system. It maintains perfusion to renal arteries when used in combination with the stent graft.

The medtech giant said that Radiant is the first and only covered stent indicated for such use. It comes from a long-term collaboration between Medtronic and Getinge. The platform leverages Getinge’s Advanta V12 balloon expandable covered stent design.

Get the full story at our sister site, Medical Tubing & Extrusion.