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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New 6-month data presented today on Abbott‘s HeartMate 3 left ventricular assist system indicated fewer adverse clotting and bleeding events than with its HearMate II.
Data came from a 6-month analysis of its pivotal Momentum 3 trial, a randomized, non-blinded study which aimed to compare the new HeartMate 3 system to the previous-generation HeartMate II. Read more
A federal judge in Texas this week ruled that emails exchanged between Medtronic and Neurovision hashing out a settlement in their patent infringement dispute constitute a valid agreement, setting the stage for a hearing on whether the subsequent, unsigned contract is binding.
Neurovision sued Medtronic in the the U.S. District Court for Eastern Texas in February 2016, alleging infringement of a pair of patents covering the “Electrode for Prolonged Monitoring of Laryngeal Electromyography” by Medtronic’s NIM nerve monitoring system. The case was stayed after Medtronic asked the Patent Trial & Appeals board for inter partes review of the patents, which the board launched for 1 of the patents Dec. 29, 2016, according to court documents. Read more
This year so far has been an especially good one for medical device company stocks. More than four-fifths of the world’s 100 largest medical device companies saw their stock values increase during the first quarter of 2017 – about half enjoyed double-digit percentage increases, according to an analysis of how the stocks of our Big 100 companies are faring. Read more
Abbott plans to restrict the use of its Absorb bioresorbable stent in Europe after a clinical study found a higher risk of serious adverse events.
In a March 31 letter to physicians (posted online April 5 by a prominent cardiologist from Atlanta), Abbott said it would restrict use of the Absorb and Absorb GT1 devices to clinical registry studies as of May 31. Read more
Medtronic yesterday confirmed the recall of its StrataMR adjustable valves and shunts, reported last month by MassDevice.com, saying 1 death has been reported but not confirmed to be associated with the issue.
The problem relates to flow resistance that could lead to under-drainage of cerebrospinal fluid, arising when the valve mechanism is adjusted to a position which causes higher-than-intended flow resistance, according to a letter dated March 2017 that the Fridley, Minn.-based company sent to physicians in Europe. Potential health consequences from the flow issue include headache, nausea, vomiting and lethargy and coma or death if the problem is not addressed. Read more