Getinge AB has acquired Healthmark Industries Co. Inc. for $320 million on a cash and debt basis in a bid to bolster its presence in sterile reprocessing in the U.S. The deal was financed using cash on hand and existing credit facilities. Getinge expects to fully integrate Healthmark’s operations by the end of 2024 and is not expected to see any material integration costs in 2023 and 2024.
Getinge AB received U.S. FDA premarket approval (PMA) for its Icast covered stent system, which has been used by clinicians for 20 years under the brand name Advanta V12. Icast is designed to treat patients with iliac arterial occlusive disease, a type of peripheral arterial disease where atherosclerosis narrows and blocks peripheral arteries.
The U.S. FDA reported yet another recall of intra-aortic balloon pumps made by Datascope Corp., an unfortunate development for patients in need of these devices that are still on the FDA’s list of devices that are in short supply. While no injuries or deaths have been reported in connection with the coiled connector cables that prompted the recall, the need to replace these cables could further crimp units needed to sustain patients during cardiac surgery procedures.
The U.S. FDA has posted or updated several recalls in the second half of January 2023, such as the class I recall of Mahurkar hemodialysis catheters distributed by Medtronic plc., reported Jan. 30. This recall is associated with two injuries but no fatalities to date, but the potential for mixing of venous and arterial blood has forced Medtronic to request that its customers quarantine any unused catheter kits, which could be a substantial amount of product given the nearly 23,000 units are affected by the recall.
Getinge AB reported that intraortic balloon pumps (IABPs) manufactured by its Datascope subsidiary are in short supply following a recall of some of these devices in 2019. Getinge said manufacturing of units and parts is proceeding at the maximum pace allowed by supply chain volatility and recommended that hospitals facing shortages contact other nearby hospitals in the event of a lack of device availability.
Getinge AB reported a partnership with Medtronic plc for the Radiant stent, the first covered stent indicated for chimney endovascular aneurysm repair (ChEVAR). This new balloon-expandable stent graft for renal arteries obtained CE mark approval on Sept. 20.
The U.S. FDA has applied a class I designation to the recall of Flow-c and Flow-e anesthesia systems manufactured by Getinge AB of Gothenburg, Sweden, due to reports of faulty on-off switches, which could lead to a failure to provide the needed suction. While no injuries or fatalities have been reported in connection with the problem, the FDA said one possible consequence of device failure is pulmonary obstruction that could ultimately lead to death.
Getinge AB is acquiring 100% of the equity in fluorescence imaging company Fluoptics SAS, a company using the technology as an aid to surgery. Getinge will, through its subsidiary Getinge Infection Control SAS, acquire all outstanding shares in Fluoptics and will pay around $27 million in cash on closing the deal.
Though the Ukraine war has had an impact on the availability of medical devices and diagnostics, a number of companies based in the U.S. and Europe have announced measures to ensure their products will reach the war-torn nation. Device companies are donating millions to nongovernmental organizations for humanitarian assistance, while the Advanced Medical Technology Association (Advamed) said its member companies are tracking the situation and are eager to pitch in with desperately needed supplies and medical equipment.
The FDA posted a recall of a vaporizer unit that is used in several anesthesia gas machines distributed by Getinge USA Sales LLC, of Wayne, N.J., an issue that has triggered eight complaints. While no injuries or deaths have been reported, this is a class I recall due to the prospect that the problem can trigger irritation of the lung as well as pulmonary edema.