How Reggie Groves reinvented Medtronic’s atrial fibrillation biz

Reva Medical (ASX:RVA) CEO Reggie Groves got her start in the medical device industry at medtech titan Medtronic. In her upcoming keynote interview at DeviceTalks West, Groves will discuss how that experience has shaped her as a leader and an innovator. Here’s a preview:

When Reggie Groves joined Medtronic (NYSE:MDT) in 2002, she didn’t know very much about the medical device industry. That was by design, she told MassDevice – the company was looking for somebody outside of the medtech world to launch their CareLink Network. It was the world’s first remote monitoring system designed to link the data in patients’ implanted devices with physicians.

Reggie Groves“I knew that (Medtronic) was a big company that was well respected and that was about all I really knew about them,” she said. “I saw what they were doing in remote device check as the start of a complete transformation of the medical device industry – moving away from being the implant to being the data managers.”

After commercializing CareLink and then moving to the regulatory and quality side of the business, Groves stepped up to build Medtronic’s atrial fibrillation ablation business. At the time, according to Groves, Johnson & Johnson (NYSE:JNJ) held a sizable lead in the AF space, followed by St. Jude.

Medtronic’s AF unit “basically didn’t exist,” Groves said – the company had previously sold its electrophysiology business. It was Groves’ job to determine how the company could build an AF division that would stand out among fierce competition.

Catch Groves’ keynote interview at DeviceTalks West on Dec. 11 – register today!

She decided to rethink the way that the company’s sales force was selling its newest technologies to electrophysiologists.

“Most companies would have said, ‘We’ve got this great big sales force, here’s another product in their tool bag. Give it to them and let them sell it.’ And I said, ‘That’s the worst thing we could do because it’s a disruptive technology and we don’t want every customer to have it.’ If you’re the sales rep who’s also selling CRT devices and ICT devices, you’re going to bundle,” she said. “Something is going to be given away and the easiest thing to give away is the new novel thing. You’ll never make any money in AF, which is why Medtronic walked away from it the first time.”

Groves set up her own sales team and told them to only sell Medtronic’s AF technology to early adopters.

“When you walk in the door for the sales meeting, if you get the ‘Oh, it’s too expensive, oh it’s not flexible enough, oh it doesn’t do enough,’ – turn around and walk out the door. That’s not an early adopter. You need to find the customers who get the value proposition,” she explained.

At the time, competitive devices from St. Jude and J&J were designed to allow the very best doctors to perform an ablation anywhere in the heart. At Medtronic, Groves was positioning the company’s AF device as usable by any electrophysiologist who was looking to isolate the pulmonary vein.

Her plan was not without pushback, according to Groves.

“It wasn’t easy, even within Medtronic. I had lots of naysayers and it took the CEO stepping in, listening to the argument and making the call,” she said. “But I got really lucky that I believed in a different approach to launching a product compared to most big companies and Medtronic let me do it my way.”

Don’t miss out on the rest of Groves’ exciting story – see her at DeviceTalks West on Dec. 11-12.

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Medtronic updates software for Puritan Bennett 980 ventilators in FDA-labeled Class I field action

Medtronic logo updated

Medtronic (NYSE:MDT) said this week that it released a software update for its Puritan Bennet 980 ventilators in a field action labeled by the FDA as Class I.

Class I designations, the FDA’s most serious classification, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.

The Puritan Bennett 980 is a mechanical ventilator intended for prescription use by trained professionals to support patient breathing, the Fridley, Minn.-based company said.

The software patch is intended to update the external USB drive performance and its impact on graphical user interface functionality, as well as the labeling displayed on the GUI during ventilator use. The update also includes product enhancements, Medtronic said.

Medtronic said that it also updated the PB980 operators manual with additional information, according to a press release.

The company said that the devices are still safe to use without the update, and that it has not received any confirmed reports of serious adverse health consequences related to the issue the patch is intended to address.

Also this week, Medtronic said that it agreed to pay $50.9 million to settle a number of U.S. Dept. of Justice probes into marketing activities from companies it acquired, including Covidien and ev3.

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Medtronic to pay $51m to settle Covidien, ev3 DoJ investigations

Medtronic logo updated

Medtronic (NYSE:MDT) said yesterday that it agreed to pay $50.9 million to settle a number of U.S. Dept. of Justice probes into marketing activities from companies it acquired, Covidien and ev3.

Medtronic said that its subsidiary ev3, acquired when the Fridley, Minn.-based medtech giant picked up Covidien in 2015, agreed to plead guilty to a misdemeanor charge related to its marketing of the Onyx Liquid Embolic System, pay $17.9 million and adopt new compliance and reporting terms for three years.

The charges relate to ev3’s marketing of the device for “unproven and potentially dangerous uses,” federal prosecutors said in a DoJ release.

The Onyx Liquid Embolic System won FDA approval in 2005 for blocking blood flow to arteriovenous malformations of the brain. Prosecutors in the case claim that sales reps from ev3 marketed the device for unapproved uses between 2005 and 2009, even after FDA officials contacted ev3 over “specific safety concerns regarding uses of Onyx outside the brain,” according to the release.

In 2012, the FDA released a warning related to the Onyx system after receiving reports of more than 100 adverse events and nine patient deaths related to use of the device.

“Ev3 disregarded laws designed to protect patient safety. The U.S. Attorney’s Office is committed to protecting patients and the integrity of federal health care programs, and we will continue to use our criminal authority to ensure that medical device manufacturers play by the rules that protect the public and ensure quality of care,” United States Attorney Andrew Lelling wrote in the DoJ release.

The $17.9 million payment includes a criminal fine of $11.9 million and the forfeiture of $6 million, according to the DoJ.

Medtronic said that it was also settling two other DoJ investigations related to Covidien and ev3’s activities prior to their acquisition in 2015.

The medtech giant said it agreed to make a payment of $13 million to resolve an investigation into the Systematic Evaluation of Patients Treated With Stroke Devices for Acute Ischemic Stroke registry. The company called the settlement “a compromise of disputed claims” and said it made “no admission that the Stratis Registry was improper or unlawful.”

In a second settlement, related to “various market-development and physician engagement activities” conducted by Covidien and ev3’s peripheral vascular and endovenous businesses prior to their acquisition, Medtronic said it agreed to pay $20 million, but admitted no fault.

“Medtronic is committed to maintaining the highest standards of ethical conduct and compliance with all applicable regulatory guidelines. The plea agreement and settlements that the Medtronic entities agreed to all concern matters that took place either largely or entirely prior to Medtronic acquiring the businesses in which the activities took place. Medtronic has made significant investments in ensuring that it fulfills its obligations to all of its stakeholders and to do business the right way,” the company wrote in a press release.

Last week, a state court jury in Indiana reportedly awarded a $112 million decision to a local spine surgeon turned medical device inventor in his five-year royalties dispute with Medtronic.

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Medtronic eyes more investment in Israel

Medtronic logo updatedMedtronic‘s (NYSE:MDT) chief executive Omar Ishrak traveled to Israel on Sunday with a team of senior executives to reportedly meet with some of the firms that the medtech giant has recently acquired, including Mazor Robotics and Nutrino.

Ishrak is also scheduled to meet with Israel’s prime minister Benjamin Netanyahu and Eli Cohen, the minister of economy and industry.

Also on this week’s trip, Medtronic reportedly signed a deal with the Israel Innovation Authority to support a new center focused on research and development.

The company has long signaled interest in the Israeli medtech arena and this year it has doubled down. Earlier this month, Medtronic announced it would pay an undisclosed amount to purchase Israel-based nutrition tech firm Nutrino. In September, Medtronic put $1.6 billion on the table to buy Mazor Robotics, a surgical robotics company that Medtronic has held a stake in since 2016.

After the Nutrino acquisition earlier this month, Medtronic’s country director for Israel Yaron Itzhari reportedly said it would not be the company’s last purchase in Israel.

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Medtronic studies use of both heat and cold for cardiac ablation

Medtronic logo updatedMedtronic today said that a St. Louis heart team has treated the first patient in the company’s Terminate AF trial, which is studying the simultaneous use of heat and cold to produce cardiac ablation for atrial fibrillation treatment.

The goal is to determine the safety and efficacy of treating persistent atrial fibrillation in patients undergoing other surgical heart procedures including bypass surgery, heart valve repair or replacement, according to the Medtronic.

During a recent open-heart surgical procedure, a team led by Dr. Ralph Damiano at the Washington University School of Medicine in St. Louis used both the Cardioblate irrigated RF system and the CryoFlex surgical ablation system. The surgical team used both Medtronic devices to make a pattern of lesions in the heart muscle in order to help it return to its normal rhythm.

“The Terminate AF trial provides a unique opportunity to study the combined use of two surgical ablation technologies to treat surgical patients who suffer from AF,” Damiano said in a news release.

“We anticipate the trial will help us uncover important procedural insights and potentially help surgeons and heart teams treat more patients with this widespread disease,” said Damiano, who is the national principal investigator of the Terminate AF trial.

The study will involve up to 15 centers in the U.S. and up to 160 patients. Researchers will assess patients at one, three, six and 12 months; the primary efficacy endpoint is for patients to not have AF after the removal of antiarrhythmic drug therapy (three months post-procedure).

“An indication for the surgical treatment of AF would enable physician training and education and would serve as the basis for ongoing clinical evidence generation,” said John Mack, VP and general manager of Medtronic’s Cardiac Surgery business.

FDA cleared Cardioblate in 2000 and CryoFlex in 2004.

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Doc inventor wins $113m in royalties spat with Medtronic

Medtronic logo updatedA state court jury in Indiana last week reportedly awarded a $112 million decision to a local spine surgeon turned medical device inventor in his five-year royalties dispute with Medtronic (NYSE:MDT).

Dr. Rick Sasso sued Medtronic in 2013, alleging that the world’s largest medical device maker shorted him on their royalties deal for the Vertex cervical spine system he helped develop, according to the Indianapolis Business Journal.

Sasso licensed some of his early inventions to Sofamor Danek, about a year before its $3.3 billion merger with Fridley, Minn.-based Medtronic in January 1999, the newspaper reported. Further deals for spine stabilization devices followed, including some that eventually hit the market under the Vertex brand. The company agreed to pay him 2% of net sales for eight years or the life of the patent if it it is used in a device covered by a valid patent claim. Sasso argued that the Vertex system is covered by several valid patents and that Medtronic left out other products that used Vertex components, undercounting the sales calculation for his royalties.

The $112.5 million verdict lodged Nov. 28 culminated a five-year campaign that saw Sasso lose several battles. In 2015 an Indiana state court found that he never transferred his patent to his corporation, meaning it could not have licensed the technology to Sofamor Danek. Medtronic, having already paid Sasso some $23 million, didn’t owe him anything more, according to the ruling, which was later upheld by the Indiana state appeals court.

After amending his complaint three times, Sasso found favor with a six-person Marshall County Circuit Court jury last week, which deliberated for six hours after a trial that lasted nearly a month, according to the business journal.

In a quarterly regulatory filing, Medtronic said it has “strong arguments to appeal the verdict” and plans to file post-trial motions appeal if necessary.

“The company has not recognized an expense in connection with this matter because it does not currently believe a loss is probable under U.S. GAAP,” the company said in the filing.

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Diabeloop wins CE Mark for hybrid closed-loop diabetes management system

Diabeloop logo - largeDiabeloop won CE Mark clearance in the European Union this month for its hybrid closed-loop diabetes management system, DBLG1.

The Paris-based company hopes to launch its “artificial pancreas” system for adults with Type I diabetes in Europe by the second quarter in 2019.

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

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FDA clears Innovative Health to reprocess major manufacturers’ catheters

Innovative Health said it has nabbed FDA clearances to reprocess diagnostic catheters made by St. Jude Medical, Medtronic and Biosense Webster.

The catheters include St. Jude Medical’s Advisor FL, Medtronic’s Torqr and Marinr and Biosense Webster’s Decanav. Innovative Health said it is the first in the industry to receive clearances to reprocess the Advisor and the Decanav, and the only reprocessor to offer services to cardiac mapping and diagnostic ultrasound catheters from all major electrophysiology device manufacturers.

Get the full story on our sister site, Medical Design & Outsourcing.

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Medtech companies, industry groups shrug off ICIJ’s “Implant Files” report

Medtech companies and industry groups have shrugged off the recently released “Implant Files” report from the International Consortium of Investigative that was highly critical of the industry, seeing shares stay steady or rising only days after the report was posted.

The highly critical “Implant Files” report, which was released early this week, is a collaborative effort overseen by the ICIJ and includes work from 252 journalists from 59 media groups across 36 countries.

On its first day of trading this week after the release of the report, industry giant Medtronic (NYSE:MDT) saw its shares rise 1.6% to close at $92.06. Other major players, including Johnson & Johnson (NYSE:JNJ), Boston Scientific (NYSE:BSX) and Zimmer Biomet (NYSE:ZBH) saw shares drop less than 1% in response to the report.

Responses from medical device industry groups varied greatly, with some expressing sympathy to the issues presented in the report and reiterating their intentions to improve global health and wellness through the use of advanced technology.

“The medical device industry understands that just one adverse event is too many, particularly if it affects you or your loved ones. It is heartbreaking when our healthcare system, which is set up to heal people, results in patients being harmed. Everyone involved in care feels the pain when a patient is hurt, from the nurses and doctors on the front lines of care, to the women and men building medical technology. Our first and primary purpose is to help patients and we do that, every day for millions of people around the globe,” MassMEDIC president & former MassDevice publisher Brian Johnson wrote in a statement in response to the ICIJ report. “Patients can feel confident that the medical devices being used to treat them are safe and have been rigorously vetted by a robust and stringent regulatory system. Independent research has shown that the overall recall rate of medical devices, cleared through the FDA is remarkably low, less than 1%. However, nobody involved in this system believes in resting on their laurels. The medical device industry, the FDA and our healthcare system will continue to seek ways to improve the process of patient safety, while giving patients access to groundbreaking new treatments that will improve their lives.”

“While there is no medical procedure that can be performed without risk, Medical Alley companies always strive to innovate and produce the safest possible technologies that deliver better outcomes for patients. Medical Alley has a history of leadership, as the birthplace of the modern medical technology industry and as the co-creator of the Medical Device Innovation Consortium. Medical Alley looks forward to working with all health stakeholders to improve the products, the regulatory process and the press coverage of the medical technology industry and the patients whose lives depend on these products,” Minnesota’s Medical Alley Association representatives wrote in response to the report.

Other groups were more dismissive of the issues covered in the release and accused investigators of “cherry-picking” dramatic stories and “overlooking the overwhelmingly positive experiences” that the industry supports.

“The ICIJ’s coverage of this dynamic industry is cherry-picking a handful of adverse outcomes at the exclusion of the nearly 200,000 medical devices currently on the market improving patient care. This only serves to frighten the millions of patients who benefit from medical technology innovation every day, while inaccurately portraying the rigorous regulatory pathways that are in place to ensure patient safety,” Medical Device Manufacturer’s Association prez & CEO Mark Leahey said in press release responding to the ICIJ report.

“Every one of us will inevitably face a moment where we will hope for a miracle to make a child, sibling, parent, grandparent or loved one well again. Whether it’s a pacemaker that keeps a heart beating, an implant that allows a child to hear for the first time, or an artificial knee that allows a grandmother to play with her grandkids, medical devices are the foundation of modern medicine, providing physicians and nurses the tools they rely on to improve patient care. Yet, instead of a comprehensive look at both the challenges and the achievements of an industry that touches almost every human life, these stories counterfeit the life-changing and life-saving solutions delivered to billions of people worldwide,” AdvaMed wrote in response to the ICIJ report. “We should never discount any patient’s experience. But by magnifying the stories of only a few individuals, we overlook the overwhelmingly positive experiences of millions of others. We take seriously all reports of patient impact, and though the medical community can never completely eliminate risk, we always strive to improve our technologies and care delivery.”

The report is the second major examination of the medtech industry to release this year, after Netflix released a highly critical documentary, titled “The Bleeding Edge,” earlier this summer.

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Is the medical device industry endangering people?

(Image from Unsplash)

The highly critical “Implant Files” report overseen by the International Consortium of Investigative Journalists skewers the medtech industry as a whole and singles out particular companies and regulatory agencies for more intense scrutiny.

The Implant Files is the second large-scale swipe at the medtech industry this year, following Netflix’s documentary, The Bleeding Edge. It includes six stories about medtech companies, the FDA and the European device approval system, a new International Medical Devices Database, resources for patients, and a list of its many international media collaborators. Investigators collected more than 8 million device-related health records over the course of the investigation, the majority of which came from the more than 5.4 million adverse event reports filed with the FDA over the past 10 years.

Get the full story on our sister site, Medical Design & Outsourcing,

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