Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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5. Grifols puts up $100m for a 49% stake in Interstate Blood Bank
Grifols said that it agreed to pay $100 million for a 49% stake in plasma collector Interstate Blood Bank.
The deal includes an option to buy the remaining 51% for another $100 million and a $10 million call option, Barcelona-based Grifols said. Read more
4. Vascular Solutions initiates voluntary recall of Guardian II valve
Vascular Solutions said today it initiated a recall of its Guardian II hemostasis valves designed for use in catheterization procedures over an increased risk of air leakage that could lead to air embolism.
The Minneapolis, Minn.-based company said the FDA labeled the recall as a Class I, the agency’s most serious classification of recall, which is used when there is a reasonable probability that product use could cause serious adverse health consequences or death. Read more
3. St. Jude Medical’s Axium chronic pain device makes its U.S. debut
St. Jude Medical today announced the U.S. debut of its Axium neurostimulator system, after the device won FDA approval in February for treating chronic pain.
The 1st patients were implanted in West Virginia and California with the Axium device, which uses dorsal root ganglion stimulation to treat moderate to severe chronic intractable pain of the lower limbs in adult patients with complex regional pain syndrome, St. Jude said. The Axium is slated to be implanted in 25 states in the coming weeks, with 100 procedures due in the 1st month after launch, the Little Canada, Minn.-based company said. Read more
2. Boston Scientific recalls Fetch 2 thrombectomy catheters
Boston Scientific recalled the Fetch 2 aspiration catheter it acquired from Bayer in 2014, after receiving complaints of shaft breakage during coronary thrombectomy procedures.
There were no injuries or deaths reported from the shaft breakage and there is no risk to patients who have already had thrombectomies using the Fetch 2 device, Marlborough, Mass.-based Boston Scientific said. The Class I recall, the FDA’s designation for problems that could cause serious injury or death, affects all 21,155 of the Fetch 2 catheters the company has on the market. Read more
1. Medtronic disputes newspaper’s Infuse story
Medtronic yesterday disputed a newspaper’s report about an internal review of some 3,647 patients implanted with its controversial Infuse bone-growth protein, saying the piece made false insinuations and omitted key facts.
The Minneapolis Star Tribune reported yesterday that Medtronic employees spent 2 years reviewing the records but failed to report the 1,000 adverse events to the FDA– including about 1,000 adverse event reports and 4 deaths – within 30 days, as the federal safety watchdog requires. The Fridley, Minn.-based company instead shut down the review in 2008; company executives said the adverse events database compiled from the review was misfiled but eventually reported to the FDA in 2013, according to the newspaper. Read more
