Stryker wins FDA PMA, launches Lifepak CR2 AED

Stryker

Stryker (NYSE:SYK) said yesterday that it launched its Lifepak CR2 defibrillator featuring the LifelinkCentral AED program manager after winning FDA premarket approval for the system.

The newly launched Lifepak CR2 AED features new technology including CPRInsight, which allows users to continue chest compressions during ECG analysis and can improve survival outcomes, the Kalamazoo, Mich.-based company said.

The Lifepak CR2 AED also features a child mode button to reduce defibrillation energy for pediatric patients and an optional bilingual feature.

The system can be connected to the LifelinkCentral AED program manager to allow an organizations AED manager to remotely monitor and manage the device to improve readiness, Stryker said.

“In order to save more lives from sudden cardiac arrest, we must save time. The Lifepak CR2 is designed to help rescuers provide higher quality CPR and to provide the fastest first shock when defibrillation is needed. Everything about it is designed to increase user confidence. The Lifepak CR2 harnesses the benefits of connectivity to provide a foundation for better care throughout the entire chain of survival and to simplify AED program management for our customers,” Stryker emergency care public access GM Ryan Landon said in a press release.

The Lifepak CR2 was previously released in Europe and Canada in 2017 and in Japan in 2018, Stryker said.

In March, Stryker said that it put $220 million on the table for OrthoSpace and its InSpace rotator cuff repair device.

The 10 largest orthopedic device companies in the world

skeleton bones orthopedic device companies orthopedics ortho

[Image courtesy of Unsplash]

Robot-assisted surgery continues to generate headlines in the orthopedics space. But there is so much more going on among the world’s largest orthopedic device companies.

Go to our sister site Medical Design & Outsourcing and discover what’s new among the 10 largest companies in the medical device industry’s ortho sector.

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Note: Medical Design & Outsourcing drew on research for its annual Big 100 list of largest medical device companies to create the 10 largest orthopedic device companies list.

 

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ReShape taps Allergan vet Bandy for CEO | Personnel Moves, April 3 2019

ReShape LifesciencesReShape Lifesciences (NSDQ:RSLS) said last week that it named Allergan (NYSE: AGN) veteran Barton Bandy to replace Dan Gladney in the corner office, effective April 1.

Gladney, who announced his retirement in January, is staying on as chairman. Bandy spent a decade at Inamed until its $3.2 billion purchase by Allergan in 2005.

“I am very pleased to welcome Bart to the ReShape team. His experience and success – particularly with the Lap-Band business at Inamed and Allergan – in addition to his leadership track record since then make Bart the perfect next leader for ReShape,” Gladney said in prepared remarks. “I would like to thank the ReShape team for the hard work and dedication during my time as CEO and I look forward to assisting in a smooth transition and continuing on as a dedicated chairman of the board.”

“This is a very exciting time to be joining ReShape. My experience leading and building medical device organizations and the company’s strategic shift to the proven Lap-Band product, which I know very well, present immediate growth opportunities,” Bandy added. “It is also an incredibly exciting time to see the next-generation, revolutionary ReShape Vest through clinical studies to commercialization. I am thrilled to be part of ReShape Lifesciences and to help drive its future success.”

 Alcon lures HP CFO Stonesifer as finance chief
Novartis (NYSE:NVS) eye business Alcon said it lured Hewlett Packard HPE CFO Timothy Stonesifer to be its new CFO ahead of Alcon’s April 9 spinout.

Current CFO David Murray “decided for family reasons to return to Europe and remain with Novartis,” the company said.

“Tim joins us at an exciting time as we become an independent organization and the world’s leading eye care device company,” Alcon CEO David Endicott said. “He is an outstanding addition to our leadership team, bringing extraordinary financial acumen and deep experience in capital markets transactions, having served as CFO for numerous companies. Tim is also respected in the financial community and known for his ability to develop top-performing finance organizations that deliver results.”

“I am excited to join the exceptional team at Alcon,” Stonesifer added. “For more than 70 years, Alcon has been synonymous with eye care. We share a passion for serving customers and a vision for delivering innovative products that will continue to shape the industry while driving profitable growth.”
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 Exsomed names Maya as CEO
ExsoMed said it named former Tenex Health CEO Bill Maya as its new chief executive effective March 16. Interim CEO Jon Holder moved to the chief revenue officer slot, the company said.
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 iCad promotes Stevens to president
iCad (NSDQ:ICAD) said it promoted its strategy & commercial chief, Stacey Stevens, to president.
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 Ex-J&J litigation head is Stryker’s new chief legal officer
Stryker (NYSE:SYK) tapped the worldwide litigation head at Johnson & Johnson (NYSE:JNJ), Rob Fletcher, to be its new chief legal officer following the April 22 departure of Michael Hutchinson, who is slated to move to VP & advisor to CEO Kevin Lobo.
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Sterilization plant closures: Here’s why you need to care

(Image by Jose Fontano on Unsplash)

The recent shutdown of a Sterigenics medical device sterilization plant in Willowbrook, Ill. has affected medtech giants such as Becton Dickinson (NYSE:BDX), Boston Scientific (NYSE:BSX), Medtronic (NYSE:MDT), Smith & Nephew (NYSE:SNN) and Stryker (NYSE:SYK), according to an FDA list of devices processed at the sterilization plant.

Medium-sized and smaller firms, including Teleflex Medical (NYSE:TFX), Arthrex and ArthroCare also had devices processed there. The Willowbrook plant sterilized 594 types of devices, including sutures, clamps, knives, stents and needles. With a Viant sterilization plant in Grand Rapids, Mich. slated to close later this year, the FDA is warning of spot shortages, and smaller medtech companies may be the hardest hit.

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

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Appeals court declines full review of $254m Zimmer loss to Stryker

Stryker, Zimmer BiometA federal appeals court declined a full review of its earlier decision to affirm a $248 million win for Stryker (NYSE:SYK) in its surgical tool patent case against Zimmer Biomet (NYSE:ZBH).

The U.S. Court of Appeals for the Federal Circuit last December upheld treble damages in the case, based on a U.S. Supreme Court decision in Halo Electronics v. Pulse Electronics that relaxed the standard for enhanced damage awards in patent infringement cases. Zimmer Biomet appealed that per curiam decision, asking for both a three-judge panel and the full Federal Circuit bench to re-evaluate the case. The court denied both petitions March 19, setting March 26 as the date for issuing the mandate of the court.

The case dates back to December 2010, when Stryker sued Zimmer the U.S. District Court for Western Michigan, alleging infringement of three patents covering wound debridement technology by Zimmer’s Pulsavac Plus device. In February 2013 a jury awarded $70 million to Stryker; Judge Robert Jonker trebled the damages in August of that year.

The Federal Circuit in 2014 rolled back that $228 million ruling, finding that Stryker failed to prove willful infringement. Stryker appealed to the Supreme Court, which vacated the appeals court’s ruling and ordered it to reconsider the case. The Supremes found that the Federal Circuit’s test was too rigid and allowed egregious infringers to evade liability.

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10+ orthopedic products from AAOS 2019 you need to know

Attendees line up to register for the American Academy of Orthopaedic Surgeons annual meeting in Las Vegas this week. More than 30,000 people were expected. (Image from AAOS)

The American Academy of Orthopaedic Surgeons (AAOS) annual meeting in Las Vegas is abuzz about robotics, according to industry analysts from SVB Leerink.

While the SVB Leerink analysts termed Stryker’s  (NYSE:SYK) Mako platform “best-in-class,” it’s an expanding category. Other major orthopedics companies are using this week’s AAOS meeting to introduce new offerings or tout updates to existing ones.

Johnson & Johnson (NYSE:JNJ), for example, said it plans to debut its Orthotaxy total knee system in 2020, with spine, hip and eventually shoulder indications likely to follow. J&J bought the French robot-assisted surgery startup in 2018, and didn’t have any photos of the prototype to share. But the analysts said it attaches to the patient table and includes a saw/bone cutting capability, like Mako. Unlike Mako, it will not have haptic capability. Rather, it gets the surgeon locked into a cutting plane and preserves the surgeon’s control of the saw (side to side and front to back) on that plane.

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

 

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Stryker pays up to $220m for OrthoSpace

OrthospaceStryker (NYSE:SYK) said today that it put $220 million on the table for OrthoSpace and its InSpace rotator cuff repair device.

Stryker said it paid $110 million in up-front cash and agreed to another $110 million in potential milestones for the Caesarea, Israel-based company.

“The acquisition of OrthoSpace is highly complementary to our existing portfolio and aligns with Stryker’s focus on investing in sports medicine,” medsurg president Andy Pierce said in prepared remarks. “We are excited about the momentum OrthoSpace has in key global markets and the additional surgical option this technology provides our customers to address a complex pathology.”

Kalamazoo, Mich.-based Stryker said the deal isn’t expected to affect its earnings this year.

Johnson & Johnson (NYSE:JNJ) and Smith & Nephew (NYSE:SNN) are both investors in OrthoSpace.

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Stryker closes Arrinex buy

Stryker, Arrinex

Stryker (NYSE:SYK) said yesterday that it closed its acquisition of Arrinex and its Clarifix cryoablation technology intended for treating chronic rhinitis.

Kalamazoo, Mich.-based Stryker said that Menlo Park, Calif.-based Arrinex was founded in 2013 and began commercializing the Clarifix technology in late 2017.

Stryker said that the acquisition will expand its ENT portfolio and that the Clarifix technology will address a large segment of the ENT market in which the company does not currently compete.

“The acquisition of Arrinex is highly complementary to Stryker’s ENT portfolio, which is part of our Neurotechnology business. This acquisition aligns with our focus on providing ENT physicians with new technologies that deliver more treatment options and better patient outcomes,” neurotechnology, instruments & spine group prez Spencer Stiles said in a press release.

Earlier this month, Stryker said that it launched a select voluntary recall of Lifepak 15 monitor/defibrillators over issues in which the device locks up and may not deliver life-saving therapy, adding that it has received six reports of deaths related to the issue.

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Stryker recalls select Lifepak 15 defibs on lock-up issues

Stryker

Stryker (NYSE:SYK) said last Friday that it is launching a select voluntary recall of Lifepak 15 monitor/defibrillators over issues in which the device locks up and may not deliver life-saving therapy, adding that it has received six reports of deaths related to the issue.

The Kalamazoo, Mich.-based company said that an issue with the Lifepak 15 may cause the device to cease functioning after it delivers a defibrillation shock, displaying a blank monitor while keeping LED lights on to indicate the device is powered.

In this state, the device “has the potential to delay delivery of the therapy, and this delay in therapy has the potential to result in serious injury or death,” Stryker wrote in a press release.

The company said that it has received 58 complaints of the issue globally, including six patient deaths reported related to the malfunction. A total 13,003 devices are potentially affected by the issue.

Stryker said that it is reaching out to customers with affected devices to schedule for a device correction, which includes updated firmware for an internal component. The company said that it hopes to complete servicing all affected devices by the end of this year, and instructed customers experiencing the issue to contact it immediately.

Stryker said that individuals should use the systems normally until corrections can be completed, and added that automatic self-tests will not identify the fault as it occurs only during defibrillation.

Last week, Stryker saw shares rise after the medical device maker beat expectations on Wall Street with its fourth quarter and full fiscal year 2018 earnings.

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Stryker shares rise on Q4, FY2018 earnings Beat

Stryker

Shares in Stryker (NYSE:SYK) have risen in after-hours trading today after the medical device maker beat expectations on Wall Street with its fourth quarter and full fiscal year 2018 earnings.

The Kalamazoo, Mich.-based company posted profits of approximately $2.1 billion, or $5.44 per share, on sales of approximately $3.8 billion for the three months ended December 31, seeing a swing from the red on the bottom-line while sales grew 9.4% compared with the same period during the previous year.

Adjusted to exclude one-time items, earnings per share were $2.18, just ahead of the $2.15 consensus on Wall Street, where analysts expected to see sales of approximately $3.7 billion, which the company topped.

For the full year, Stryker posted profits of approximately $3.6 billion, or $9.34 per share, on sales of approximately $13.6 billion, for bottom-line growth of 248.3% while sales grew 9.3% compared with the previous year.

After adjusting for one-time items, earnings per share for the year were $7.31, just ahead of the $7.28 consensus on Wall Street where analysts expected to see sales of approximately $13.5 billion, which the company topped.

“We had an excellent finish to 2018 with the best organic sales growth in a decade, and strong adjusted earnings performance. Our multi-year momentum reflects the strength of our diversified model, progress on globalization and outstanding people and culture. We are well positioned to deliver for our customers, employees and shareholders in 2019 and beyond,” chair & CEO Kevin Lobo said in a press release.

The company released guidance for the coming fiscal year, expecting to see net sales growth of between 6.5% and 7.5% with adjusted net earnings per diluted share of between $8.00 and $8.20. Stryker added that it expects to post adjusted EPS of between $1.80 and $1.85 for the first quarter of 2019.

Shares in Stryker have risen approximately 6.2% in after hours trading today, at $171 as of 4:16 p.m. EST.

Late last month, the U.S. Court of Appeals for the Federal Circuit affirmed Stryker’s enhanced $248 million win in a surgical tool patent case against Zimmer Biomet (NYSE:ZBH).

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