Abbott’s Absorb fares well again against Xience in Japanese study

Abbott (NYSE:ABT) today released positive data from a Japanese study of its Absorb fully dissolving heart stent that pitted it against its own Xience permanent drug eluting stent. The results were announced at the European Society of Cardiology’s annual meeting in London.

The 400 patient multi-center, randomized Absorb study, published in the European Heart Journal, set out to compare the safety and effectiveness of the 2 stents in patients with coronary artery disease.

The study reported a rate of target lesion failure, the primary endpoint of the trial, of 4.2% for the Absorb stent and 3.8% for its Xience stent at 1 year. Target lesion failure includes heart disease-related deaths, heart attacks due to the treated vessel and repeat procedures.

Rates of angiographic late lumen loss, the trial’s secondary endpoint, were also similar between the 2 stents, according to the study, varying by 0.02 mm at maximum.

Stent thrombosis rates were similar between the cohorts at 1.5%, and the rate of repeat procedures was 2.6% for the Absorb group and 2.3% for the Xience group.

“The results of the Absorb Japan study  continue to affirm that Absorb shows strong performance near-term and preserves the vessel for potential future procedures. Fully dissolving heart stents are the next evolution in percutaneous coronary intervention and are designed to leave nothing behind in the body, thus restoring the vessel more naturally over time, which cannot be achieved with a permanent drug eluting stent,” principal investigator Dr. Takeshi Kimura of Japan’s Kyoto University Hospital said in a press release.

“The Absorb Japan results contribute to the growing body of Absorb data, providing further clinical evidence that the fully dissolving stent initially functions like a permanent, metallic stent by opening up blocked heart vessels and restoring blood flow. However, unlike a metallic drug eluting stent, Absorb naturally dissolves over time, leaving nothing behind. The fact that Absorb completely dissolves means that the restored vessel has the potential to move as it needs to, based on lifestyle activities,” vascular medical affairs chief medical officer Dr. Charles Simonton said in a prepared statement.

In May, Abbott won CE Mark approval in the European Union for a next-generation delivery device for its Absorb stent. The GT1 upgrade consists of an updated delivery catheter, which Abbott said incorporates several improvements.

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Stryker closes Muka Metal buyout

Stryker (NYSE:SYK) said today it closed its purchase of Turkish hospital bed and stretcher maker Muka Metal for an undisclosed amount.

Kayseri, Turkey-based Muka began producing hospital beds in 2004, and has expanded into patient handling equipment, stretchers and hospital furniture. The company, founded in 1966, developed the 1st wireless nurse calling system, and exports to 60 countries across the U.S. It also makes non-medical products, including office furniture and household electrical appliances.

The deal was officially announced in July, with Stryker commenting that the “acquisition of Muka aligns with our strategy to expand our global presence through existing channels with an established brand.”

Stryker will use the purchase to bolster its offerings of beds and stretchers, as well as helping to drive growth in Turkey and other regions.

The Kalamazoo, Mich.-based company said the transaction is expected to be neutral in terms of the company’s 2015 earnings per share excluding acquisitions, according to a press release.

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HeartFlow study shows reduced unnecessary ICA with FFRct

HeartFlow presented data from a clinical trial of its FFRct analysis that showed a significant reduction in unnecessary invasive coronary angiography after evaluation with the device. The data was presented at European Society of Cardiology’s annual meeting in London today.

HeartFlow’s FFRct platform is an imaging approach that helps physicians treat coronary artery disease by getting a detailed look at the extent of blockage and blood flow. The technology allows the company to approach a problem cardiologists have been struggling with for a long time, CEO John Stevens told MassDevice.com in an interview.

“This is what we’ve really focused on in the last 5 and a half years. The clinical question that cardiologists ask tens of millions of times every year around the world – ‘does my patient have coronary artery disease, yes or no, and if so, what do I do about it?’ And that is a remarkably hard question to answer,” Stevens said.

Data from the study of the company’s device showed that it is helping physicians get closer to answering that question.

The 580-patient multi-center prospective Platform trial reported that among patients who had a planned ICA, 73% showed no significant blockage or obstruction.

To compare, only 12% of patients who were evaluated with HeartWare’s FFRct platform who went on to have an ICA procedure found no blockage or obstruction. In 61% of patients, the FFRct test resulted in the cancellation of a planned invasive test, according to the study.

Despite that difference, both ICA only and FFRct evaluated patients had similar rates of revascularization at 31.6% and 28.5%, respectively.

But the reduction in unnecessary invasive procedures is important, Stevens said, as more procedures inherently raises the rate of adverse events and other related issues.

“In the current state of affairs, the way we are practicing in the U.S. today, the number of patients going to the cath lab that don’t have any obstructive disease is well over 50%,” Stevens said.

The technology, and its ability to help avoid unnecessary interventions, could be the 1st signs of a fundamental shift in how coronary artery diseases is managed, Stevens said.

“I think this was a real world demonstration of, I think, how practice might change in the coming years. So, you see the patient’s quality of life we want to see, the economic benefits we want to see, and finally there wasn’t a single adverse event,” Stevens said.

Stevens said the report wasn’t all the data, however, with economic and quality of life data to be presented at a late-breaking clinical trial at the Transcatheter Cardiovascular Therapeutics meeting in October.

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NovoCure files for $300m IPO

NovoCure registered for an initial public offering that could fetch as much as $300 million for its tumor-zapping Optune brain cancer treatment as it awaits a decision from the FDA on a new indication for the device.

The federal safety watchdog granted pre-market approval for Optune in April 2011 for adult patients with glioblastoma whose cancer recurred after chemotherapy. Last April, the company applied for another indication, newly diagnosed glioblastoma, under priority review from the FDA.

The Optune device uses NovoCure’s “tumor treating fields,” which use low-intensity, intermediate-frequency alternating electric fields to kill cancer cells. It’s on the market in the U.S., Germany, Switzerland and Japan, NovoCure said.

“Upon FDA approval of Optune for newly diagnosed GBM, we believe TTFields will transform the standard of care for patients with newly diagnosed and recurrent GBM,” NovoCure said in its IPO filing, noting that a Phase III pivotal trial was halted early after it met its endpoints after showing “significant improvements in both progression-free and overall survival” in GBM patients. More than 1,600 patients have been treated using Optune, the company said.

NovoCure said it has clinical programs in place for other types of cancer, including metastases, pancreatic, ovarian, mesothelioma and advanced non-small cell lung cancer.

NovoCure’s losses grew 4.3% to -$80.7 million last year on sales of $15.5 million, for top-line growth of 49.5%, and the company said it expects to be in the red for “at least the next several years.” The company, which is based on Jersey, an island in the English Channel, had deficits of $329.1 million as of June 30, according to the filing.

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Diabetes: CeQur raises $100m for PaQ 3-day insulin device

CeQur said today that it raised a Series C round worth $100 million in what its backers called the largest medtech financing in Europe since 2006. CeQur said it plans to use the proceeds to further the planned 2016 launch of the 2nd generation of its PaQ 3-day insulin device for Type II diabetics.

Woodford Investment Management and Arthurian Life Sciences led the round, with prior backers Endeavour Vision, Schroder & Co. Banque and VI Partners also getting in on the round. CeQur, which is based in Lucerne, Switzerland and Marlborough, Mass., raised $27 million in a Series B round in April 2014 and closed a $30 million Series A round back in January 2010. The 1st-generation PaQ device won CE Mark approval in the European Union in November 2012.

PaQ, a patch-like device, is designed to deliver both basal insulin and on-demand bolus insulin over 3 days. CeQur said that, having made some 12,000 of the devices, it’s optimized the device for high-volume, low-cost manufacturing ahead of its planned commercialization. http://ift.tt/1JzKrp5

“We are very excited to work with such experienced investors who share our views about the significant opportunity PaQ brings to transform the lives of millions of people with type 2 diabetes,” CEO Doug Lawrence said in prepared remarks. “Today when people with Type II diabetes progress to insulin, they need to inject, and current alternatives have cost and complexity limitations. CeQur’s 2nd-generation PaQ will provide a superior alternative to injection therapy and allow us to build a high-growth business in the emerging category of simple and cost-effective insulin infusion to benefit patients, physicians and payors.”

“CeQur has a world-class management team with a best-in-class device that provides a much needed alternative for millions of people with type 2 diabetes on insulin injections. This was truly a unique and very compelling investment opportunity, and we were delighted to again work closely with Neil Woodford to make this significant investment,” added Arthurian Life Sciences chairman Chris Evans.

Material from Reuters was used in this report.

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Medtronic pays $150m for Medina Medical

Medtronic (NYSE:MDT) yesterday said it agreed to pay $150 million to acquire Medina Medical and its embolization coil for treating brain aneurysms.

The Medina device is a self-expanding mesh designed to fill the inside of an aneurysm. Menlo Park, Calif.-based Medina won CE Mark approval in the European Union for the device in September 2014, a month after naming ex-Foundry partner Erik Engelson to be its new CEO. Back in October 2012, the company raised more than $6.5 million in an equity offering that aimed to raise $9.5 million.

Medtronic said it already owned a stake in Medina, meaning a pre-tax gain for its 2nd-quarter 2016 balance sheet. The deal includes an up-front payment of $150 million plus milestones pegged to unspecified events. Additional terms were not disclosed.

“Medtronic is committed to fighting stroke through the innovative therapies we bring to clinicians and patients. Medina Medical’s breakthrough technology makes it a natural fit with our Neurovascular portfolio, further strengthening our hemorrhagic stroke portfolio,” neurovascular president Brett Wall said in prepared remarks. “The Medina embolization device features advanced technology to treat cerebral aneurysms that we think can 1 day disrupt the coil market.”

“This acquisition offers Medina Medical a unique opportunity to bring together our breakthrough technologies with Medtronic’s leading clinical, regulatory, market development, and commercial expertise,” Engelson added. “We look forward to working closely with Medtronic to provide expanded access and economic efficiencies to our clinical partners in fighting stroke – particularly aneurysms and hemorrhagic stroke.”

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Anvisa formally recognizes MDSAP program for foreign quality system audits

By Stewart Eisenhart, Emergo Group

Brazilian medical device market regulator ANVISA has formally recognized a program whereby the agency will accept quality system certifications from US, Canadian and/or Australian regulators in order to register devices from foreign manufacturers for sale in the country.

The new resolution (link in Portuguese) states that any auditing organization that complies with requirements of the Medical Device Single Audit Program (MDSAP) will be recognized by ANVISA and published in the Brazilian government’s official gazette.

By officially recognizing MDSAP, Brazilian regulators may now proceed with developing and providing specific criteria and requirements in order to accept quality system audit reports from accredited US, Australian or Canadian auditors or inspectors.

For foreign manufacturers hesitant to enter the Brazilian market because ofBrazilian Good Manufacturing Practice (BGMP) requirements, ANVISA’s formal recognition of MDSAP shows that the regulator is serious about providing alternate quality system compliance options.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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