Report: Medtronic to close Portsmouth, N.H. transformative solutions facility

Medtronic logo updated

Medtronic (NYSE:MDT) said this week that it plans to close its Portsmouth, N.H.-based transformative solutions facility within the year, according to a Portsmouth Herald report.

The Fridley, Minn.-based company recently informed employees at the facilities that it planned to eliminate its Portsmouth jobs, according to the report. The facilities currently employ 150 individuals.

Medtronic spokesperson Brett Cromwell said that the transformative solutions division had announced changes “being made to help focus the business and strengthen its financial position,” according to the Portsmouth Herald.

“The business is being restructured and will report into Medtronic’s enabling technologies business in Louisville, Colorado, beginning April 27. As a result of the transition, the Portsmouth facility will eventually be closed, most likely within the next 12 months,” Cromwell said in a statement, according to the report.

Cromwell could not identify exactly which positions would be impacted, but indicated that many of the roles would be transitioned from Portsmouth to its Louisville, Colo.-based facilities.

“Portsmouth employees will have the opportunity to apply for those positions, as well as any other open positions at Medtronic. Any employees impacted by this transition will be offered a severance package and outplacement services,” Cromwell said, according to the Portsmouth Herald report.

Yesterday, Medtronic said that it launched its Deep Brain Stimulation system intended for medically-refractory epilepsy in the U.S.

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Late mortality rates ‘inadvertently reversed’ in 5-year study of paclitaxel-eluting stent

Cook Medical - updated logoThe journal Circulation said this week that the all-cause mortality rates in a study comparing a paclitaxel stent and percutaneous transluminal angioplasty in people with peripheral artery disease were “inadvertently reversed” by the authors.

In the first version of the paper, originally published in 2016, researchers reported that the 5-year all-cause mortality rate for people treated with Cook Medical‘s Zilver PTX stent was 10.2% and 16.9% for the PTA group. But the correction reversed those numbers.

Get the full story at our sister site, Drug Delivery Business News.

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Medtronic launches DBS for medically-refractory epilepsy in the U.S.

Medtronic logo updated

Medtronic (NYSE:MDT) said today that it launched its Deep Brain Stimulation system intended for medically-refractory epilepsy in the U.S.

The Fridley, Minn.-based company said that the first patient was implanted with the system at Atlanta’s Emory University.

“At Medtronic, we have a long-standing commitment to helping patients with medically refractory epilepsy through DBS, and we continue to explore other treatments and solutions along the epilepsy treatment pathway. With the FDA approval, commercial launch, and policy updates from several health insurers, we are positioned to help more people than ever before. We are also initiating a 140 subject post-approval study where we will evaluate three-year safety and effectiveness outcomes at centers in the U.S. and Europe,” brain modulation biz GM Mike Daly said in a press release.

Medtronic’s DBS therapy functions through the delivery of controlled electrical pulses to the anterior nucleus of the thalamus which is part of a network involved in seizures, the company said.

The DBS treatment won premarket approval last May for patients 18 years or older who are refractory or drug resistant to three or more antiepileptic medications, the company said.

Approval came based on seven years of data from the company’s SANTE trial, which examined the use of the DBS system in 110 patients with medically refractory epilepsy with partial-onset seizures.

“The commercial availability of DBS provides an important surgical treatment option for patients who suffer from epilepsy and do not respond to medication. ANT DBS has been shown to significantly reduce the frequency and severity of seizures and improve quality of life out to seven years. The first patient implanted since commercialization is doing very well. While it has only been 2 months since the system was turned on, his frequency of seizures has declined by more than 50 percent, and we expect improvement to increase further with additional programming sessions,” SANTE trial primary investigator Dr. Robert Gross of the Emory University Department of Neurosurgery said in a prepared release.

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Medtronic looks to retire up to $5b in debt

Medtronic logo updated

Medtronic (NYSE:MDT) today announced a cash tender offer for up to $5 billion in outstanding debt, according to recently posted SEC filing.

In the offer, which is being made through Medtronic Inc. and its Covidien International Finance subsidiary, the Fridley, Minn.-based company hopes to retire $2.5 billion in 2.5% senior notes due 2020 and $600 million in 4.2% senior notes due 2020.

The offer also includes up to $1.9 billion in various other securities, including 6.55% senior notes due 2037, 6.5% senior notes due 2039, 5.55% notes due 2040, 4.625% notes due 2044, 4.5% notes due 2042, 4.625% senior notes due 2045, 4.375% senior notes due 2035, 4.125% notes due 2021 and 4% notes due 2043, according to the filing.

The tender offer is set to expire on March 19, Medtronic said.

Yesterday, Medtronic saw shares rise after the medical device giant posted third quarter fiscal year 2019 earnings that beat expectations on Wall Street.

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Medtronic risk prediction tool could help prevent opioid deaths: Here’s how

Medtronic logo updatedMedtronic officials continue to hone their arguments for how the company’s capnography and oximetry systems could reduce potentially deadly opioid-induced respiratory compromise.

The medical device giant on Feb. 17 announced preliminary results of its Prodigy study, in which the company’s Microstream and Nellcor monitoring technology provided continuous capnography and oximetry for 1,496 patients across 16 sites in the U.S., Europe and Asia.

The study resulted in what Medtronic says is an easy-to-use risk prediction tool. Called the Prodigy score, it helps identify patients on the hospital general care floor who are taking opioid medications and are at high risk of developing a respiratory compromise.

The score takes into account variables including age, gender, sleep disorders, chronic heart failure and opioid naïvety. During the Prodigy study, it identified more than three-fourths of patients with confirmed respiratory depression.

Overall, opioid-induced respiratory depression occurred in nearly half of the patients in the study.

“Clinical evidence shows that acute and unexpected respiratory compromise on the general care floor is increasingly common. Until now, we have not been successful in predicting which patients are at high risk when recovering on the general care floor,” said Dr. Ashish Khanna, the primary study investigator and an associate professor of anesthesiology and intensivist at the Wake Forest School of Medicine.

“These data validate an easy-to-use [opioid-induced respiratory depression] risk prediction tool to identify patients at the highest risk and guide early intervention using continuous capnography-based monitoring. Early identification and intervention in these high-risk patients has the potential to improve patient safety and decrease the economic and clinical burden of unplanned ICU admissions,” Khanna said in a news release.

Opioid-induced respiratory depression is a “common, costly and deadly but preventable condition,” and Medtronic through the Prodigy study is committed to help, said Vafa Jamali, SVP and president of the Medtronic’s respiratory, gastrointestinal and informatics business.

“We are encouraged by the data demonstrating the use of the Prodigy OIRD risk prediction tool,” Jamali said. “It can help clinicians prioritize resources by identifying those patients at highest risk on the general care floor who should be continuously monitored with capnography and pulse oximetry.”



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Medtronic shares rise on FY2019 Q3 earnings beat

Medtronic logo updated

Shares in Medtronic (NYSE:MDT) are up today after the medical device giant posted third quarter fiscal year 2019 earnings that beat expectations on Wall Street.

The Fridley, Minn.-based company posted profits of approximately $1.27 billion, or 94¢ per share, on sales of approximately $7.55 billion for the three months ended January 25, seeing a swing from red ink on the bottom line while sales grew 2.4% compared with the same period during the previous fiscal year.

After adjusting to exclude one-time items, earnings per share were $1.27, just ahead of the $1.24 consensus on Wall Street where analysts expected to see sales of $7.52 billion, which the company also topped.

“Our organization executed on multiple fronts to deliver a strong quarter for Medtronic. Revenue outperformance in our minimally invasive Therapies and restorative therapies groups, as well as broad strength across emerging markets, helped to offset certain market-specific headwinds we faced during the quarter, reflecting the full benefits of our diversification,” CEO Omar Ishrak said in a press release.

Medtronic updated its guidance for its coming fourth quarter and full fiscal year 2019, saying it now expects to see revenue growth of between 5.25% and 5.5%, narrowed from previous guidance of between 5.0% and 5.5%.

The company increased its fiscal year 2019 diluted non-GAAP EPS guidance to between $5.14 and $5.16, up from earlier guidance of between $5.10 and $5.15. Medtronic also lifted its free cash flow guidance to between $5.0 billion and $5.2 billion from between $4.7 billion and $5.1 billion.

“We continue to make progress on our robust and exciting pipeline, which contains more opportunities for growth than at any time in our company’s history. We expect this forthcoming innovation to disrupt existing markets and invent new markets, all with the goal of creating significant value – for patients, physicians, healthcare systems, and for our shareholders,” CEO Ishrak said in a prepared statement.

Shares in Medtronic are up approximately 2% so far today, at $94.09 as of 10:10 a.m. EST.

Last week, the FDA slapped a Class I status on a recall of approximately 156,957 Medtronic dual chamber pacemakers.

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Medtronic: Patient deaths left out of paclitaxel-coated balloon analysis

Medtronic logo updatedMedtronic (NYSE:MDT) said last week that it inadvertently omitted an undisclosed number of patient deaths from recent studies of its paclitaxel-coated balloons.

The company noted that the mistake ultimately does not affect the conclusion that there was no statistically significant difference in all-cause mortality between its In.Pact Admiral drug-coated balloon and plain balloon angioplasty at five years.

Get the full story at our sister site, Drug Delivery Business News.

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Medtronic wins FDA’s breakthrough status for closed-loop insulin system

Medtronic logo updatedMedtronic (NYSE:MDT) said today that it won breakthrough status from the FDA for its investigational personalized closed-loop insulin pump system.

The company touted its technology as enabling automated insulin delivery in a real-time, adaptable and personalized fashion.

Get the full story at our sister site, Drug Delivery Business News.

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Medtronic inks 5-year value-based healthcare deal with S.C. hospital

Medtronic logo updated

Medtronic (NYSE:MDT) said today that it inked a five-year value-based healthcare partnership deal with the Medical University of South Carolina, looking to improve health outcomes, patient care experiences and reduce costs.

Fridley, Minn.-based Medtronic said the partnership will initially focus on addressing chronic disease and acute conditions prevalent in the region.

An initial program involves standardizing a vascular disease care pathway across the continuum of patient care and implementing a model for identifying, diagnosing, treating and follow-up care for patients with vascular disease.

The two groups also plan to implement a standardized care pathway program for joint replacement patients addressing the bundled payment methodology used by the Centers for Medicare and Medicaid Services.

“This strategic partnership with Medtronic is based on our shared vision and drive to lead the transformation of health care delivery. It’s about providing what’s best for our patients. The mutual goal of our organizations is to deliver the best patient outcomes at the lowest cost possible. That’s the true meaning of value-based health care. Through our collaborative partnership, we plan to combat chronic disease and address community health needs in South Carolina and beyond. We look forward to an innovative and productive relationship with Medtronic and will share tangible results of our efforts as our strategic partnership evolves,” MUSC prez Dr. David Cole said in a press release.

“Together with MUSC, we are committed to fundamentally improving the way patient care is delivered. Medtronic has a long history of collaboration with health care providers to invent and develop new markets to solve a variety of clinical problems. The partnership with MUSC is an extension of that collaboration, as we look to systematically work together to develop scalable programs aimed at improving patient outcomes while reducing the cost of care,” CEO Omar Ishrak said in a prepared statement.

Last week, Medtronic said that it won expanded FDA approval for its Pipeline Flex embolization device.

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3M names CEO Roman as board chair | Personnel Moves – February 7, 2019

3M CEO Roman

3M (NYSE:MMM) said yesterday that its board of directors nominated CEO Mike Roman as its new chairperson, with current exec chair Inge Thulin announcing their intention to retire.

The move is slated to take effect following the St. Paul, Minn.-based company’s annual meeting of shareholders on May 14.

“Under Inge’s leadership, 3M evolved into a more agile and competitive enterprise while generating tremendous value for customers and shareholders. Today’s decision underscores the Board’s confidence in Mike’s leadership and strong character to lead 3M into the future as both CEO and chairman of the board,” board independent lead director Mike Eskew said in a prepared statement.

“I am proud of 3M, our people, and what we’ve accomplished together. I’ve known and worked very closely with Mike, including since his appointment as CEO. I’m very confident that 3M’s best days are ahead and Mike will do a fantastic job leading 3M into the future,” Thulin said in a press release.

“It’s an honor to be nominated to the additional role of chairman of the board. I thank Inge for his leadership and partnership throughout my career, especially over the past year in his role as executive chairman,” Roman said in prepared remarks.

 VentureMed names former NxThera prez Paulson as CEO

VentureMed said on Tuesday that it named former NxThera prez & CEO J. Robert Paulson, Jr. as its new prez & chief executive, effective January 1.

Paulson will replace Gary Smith, who the Toledo, Ohio-based company said will continue to serve as a member of the leadership team.

Prior to joining VentureMed, Paulson served as prez, CEO and board director of NxThera from 2009 until the company’s acquisition by Boston Scientific (NYSE:BSX) last year.

Before joining NxThera, Paulson also held president and CEO positions with Restore Medical, which was acquired by Medtronic (NYSE:MDT) in 2008.

“Bob brings tremendous knowledge and experience to the VentureMed Group, together with a strong track record of building successful teams and commercializing compelling new medical technologies. We look forward to Bob’s contributions and leadership during this next phase of the company’s growth. On behalf of the board of directors, I would like to thank Gary for his significant contributions, which have created a solid foundation for the future success of the VentureMed Group,” board member and Endeavour Vision partner Alexander Schmitz said in a press release.

“I am thrilled to be working with our team and physician partners to expand adoption of our Flex VP System, to improve the treatment of peripheral arterial disease, and AV fistulas and grafts, in millions of patients around the world,” Paulson said in a prepared statement.

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 Repro-Med Systems lifts prez & CCO Petigrew to the corner office

Repro-Med Systems said on Monday that its reconstituted board of directors promoted prez & CCO Don Petigrew to the position of CEO.

Petigrew will replace interim CEO and chair Dan Goldberger, who is assuming the position of exec board chair, the Chester, N.Y.-based company said.

“As an industry leader in the home infusion market, RMS delivers invaluable medical and lifestyle solutions to patients who rely on our products. My vision as CEO is to innovate and improve our products such as the FREEDOM system, partner with the medical community to identify new patient needs and expand our reach in the US and abroad. Achieving these goals is a win-win for patients, providers and shareholders alike,” prez & CEO Petigrew said in a prepared statement.

“Don’s presence since joining the company has been immediately accretive. His experience in the infusion industry has uniquely positioned him to build upon the company’s successful foundation. I look forward to working with Don and the team at RMS and our newly reconstituted Board of Directors in my role as Executive Chairman to help the company achieve its potential and execute on our strategy,” exec chair Goldberger said in a press release.

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 Myomo taps Henry as CFO

Myomo said yesterday that it named David Henry as its new CFO, taking over for current chief financial officer Ralph Goldwasser, who is retiring effective February 18.

The Cambridge, Mass.-based company said that Goldwasser will stay on to help in the transition for an anticipated three months.

Prior to joining Myomo, Henry served as chief financial officer of Eos Energy Storage, and has also held CFO positions with American Semiconductor Corp and AMI Semiconductor.

“I would like to thank Ralph, who has worked with me at Myomo for the past eight years, first as a consulting CFO and later as our chief financial officer, enabling us to raise growth capital, including leading our June 2017 IPO and listing on the NYSE American exchange and our follow-on equity financing in December of 2017. We wish Ralph the best in his retirement. We are pleased to have David Henry join Myomo’s executive team as chief financial officer. David has extensive experience to support our efforts to grow the company,” chair & CEO Paul Gudonis said in a press release.

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 Amazon, Berkshire Hathaway & JP Morgan venture snags Kutan as CTO

The joint healthcare venture between Amazon (NSDQ:AMZN), Berkshire Hathaway and J.P. Morgan Chase has picked up former tech chief at digital healthcare startup ZocDoc Serkan Kutan as its new chief technology officer, according to a recent CNBC report.

The move was confirmed as official by the new health venture, according to the report.

“I am thrilled to now announced that I am serving as CTO of this new venture,” Kutan wrote in a LinkedIn posting, according to CNBC.

During his time at ZocDoc, Kutan was tasked with building technology allowing consumers to book doctors appoints digitally, according to the report.

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