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. Boehringer Ingelheim touts Stiolto Respimat data
Boehringer Ingelheim yesterday touted results from a Phase III trial showing that its Stiolto Respimat, a drug-device combination helps people with chronic obstructive pulmonary disease walk for longer periods of time while relieving some shortness of breath.
When participants with moderate to severe COPD took Stiolto Respimat, a combination of tiotropium bromide and olodaterol, along with exercise, their exercise capacity increased by 45.8% compared to those receiving a placebo. The Physacto trial is a part of the Tovito Phase III clinical trial, investigating the efficacy of Respimat as a maintenance therapy for COPD. Read more
4. FDA: No evidence of data manipulation in clinical trials for Bayer’s Essure
The FDA said it completed a review of a trade complaint which alleged that Bayer was engaged in clinical trial misconduct and altering data, saying it found no signs of manipulation.
The agency set out to review the allegations, which accused Bayer of clinical trial misconduct, “notably that clinical trial participants’ medical records were altered to reflect more favorable data about participants’ experiences, and that the sponsor violated the terms of the PMA approval order and violated laws that relate to the manufacturing and marketing of Essure,” according to an FDA release. Read more
3. Medtronic opens office in Vietnam
Medtronic said yesterday it opened a new office in Vietnam to greater serve the region.
Fridley, Minn.-based Medtronic said it will “make important contributions” to fight cardiovascular diseases and cancer in the region, 2 of the highest contributors of non-communicable disease mortality in the region according to the World Health Organization. Read more
2. Edwards Lifesciences’ CardiAQ Valve wants to add $23m to Neovasc’s $70m trade theft loss
Edwards Lifesciences subsidiary CardiAQ Valve Technologies wants a federal judge in Massachusetts to add 33%, or more than $23 million, to the $70 million trade theft verdict lodged against Neovasc earlier this year.
A federal jury in Massachusetts found in May that Neovasc stole trade secrets and breached a non-disclosure agreement with CardiAQ in developing the Tiara transcatheter mitral valve replacement. (Edwards inherited the lawsuit when it acquired CardiAQ Valve for $400 million in August 2014.) Later in May, a Bay State federal judge tossed a claim alleging that Neovasc violated Massachusetts laws against unfair competition and unfair or deceptive practices, ruling that most of the wrongdoing took place in Canada, not Massachusetts as required by the statute. Read more
1. Rox Medical raises $40m Series E for hypertension ‘stent’
Rox Medical said today that it raised a $40 million Series E round for the stent-like Coupler device it developed to treat hypertension by connecting the femoral artery and the femoral vein.
The round was led by the Novartis Venture Fund and Apple Tree Partners, with participation from prior backers Versant Ventures and Domain Associates, San Clemente, Calif.-based Rox said. Read more
