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. Dexcom warns on G4, G5 CGMs
Dexcom Inc. today released a customer notice warning of possible malfunctions with the audible alarms and alerts from its G4 Platinum and G5 Mobile continuous glucose monitor systems.
San Diego, Calif.-based Dexcom said it received an “increase in complaints related to audible alarms and alerts,” associated with the 2 CGM units. Read more
4. St. Jude Medical launches Trifecta GT valve in Europe
St. Jude Medical said today that it launched its Trifecta GT aortic valve replacement in the European Union, hailing the device as its most advanced tissue valve.
The Trifecta GT won CE Mark approval in the EU in February, the St. Paul, Minn.-based company said. The valve’s titanium stent is covered with tissue to improve tissue-to-tissue contact during the leaflets’ motion. St. Jude said the Trifecta GT also features its Linx anticalcification treatment. Read more
3. ReCor Medical launches trial for Paradise renal denervation device
ReCor Medical said today that it’s enrolled the 1st patients in the 292-patient Radiance-HTN study of its Paradise renal denervation device for treating hypertension.
The blinded, randomized and sham-controlled trial is designed to evaluate the Paradise system in patients with essential hypertension taking 2 or fewer medications and patients with treatment-resistant hypertension on a minimum of 3 drugs. The trial has 2 arms: The Solo cohort is designed to evaluate the essential hypertension patients; the Trio cohort will study the treatment-resistant group, Palo Alto, Calif., and Amsterdam-based ReCor said. Read more
2. Johnson & Johnson’s $5m mesh settlement could push costs higher
Johnson & Johnson subsidiary Ethicon could be facing a steeper-than-expected tab when it comes to settling the more than 46,000 product liability lawsuits brought over its pelvic mesh products, after details about 1 settlement became public in a legal filing.
J&J agreed to pay $5 million to settle plaintiff Pamela Wicker’s lawsuit alleging that its Prolift mesh caused her injuries, Bloomberg reported. Wicker’s lawyer, Adam Slater, revealed the $5 million payment in a November 2015 filing seeking Judge Brian Marinotti’s approval for his $1.65 million legal fee, according to the news service. Read more
1. Report: Baxter to shutter Colorado plant
Baxter is reportedly planning to shutter a plant in Englewood, Colo., over the next year.
“Baxter has informed employees in its [Douglas County] … facility of the company’s plans to exit the facility over the next 12 months to enable effective deployment of the company’s product portfolio in order to best meet the needs of patients,” spokesman John O’Malley told the Denver Business Journal. “With this decision, our primary goal is to minimize the disruption to the customers and the patients that we serve, and support our employees through the change. Some employees will work remotely or relocate to other Baxter facilities. Baxter is still evaluating where the manufacturing currently taking place will transition to.” Read more
