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Articles from 2013 In February


FDA Approves Novel ICD Device Made by Biotronik. But will the Company Win Share in the U.S.?

 Biotronik, the German medical device company, announced the U.S. approval of a new ICD on Monday, that it described as a “game-changer.”

It is the first single-lead ICD capable of performing both pacing and atrial sensing to win the regulatory nod from the Food and Drug Administration.

 The question is how much traction Biotronik will be able to gain in the U.S. ICD marketplace given the dominance of Medtronic and other players like Boston Scientific and St. Jude Medical.

The Lumax DX System
 

ICDs are implantable cardioverter defibrillators that are capable of shocking a person back to life when a person suffers heart failure.

In an email interview, Rex Richmond, Biotronik’s vice president of marketing and communications, says that the Lumax DX System provides the benefits of the single and dual-chamber in a single-lead device.

“About 40 percent of patients, who receive an ICD, receive a single chamber device, which are designed to only to sense changes in ventricular rhythm and are unable to sense atrial arrhythmias, such as AF, correctly,” Richmond says. “This can result in an increased risk of an inappropriate shock or potentially a stroke.”

But there are other benefits beyond simply the clinical. For instance, because there is only one lead to implant in the heart region, the procedure is less complex and less costly. Further, there are fewer lead complications, Richmond said because of fewer leads in the heart. For all the above reasons, the product may be attractive to electrophysiologists who typically implant dual-chamber ICDs.

But in the last 12 months, another ICD has been touted as revolutionary as well. And that is Boston Scientific’s S-ICD, developed by Cameron Health which it acquired in 2012. The S-ICD system has also been approved and that has no leads in the heart – period. The subcutaneous ICD has placed just beneath the skin.

Previously, Ken Stein, the chief medical officer of Boston Scientific’s cardiac rhythm management division has said that leads are the weak links in the ICD system, and by eliminating the need for those the S-ICD makes having an ICD safer for patients.

But Richmond of Biotronik believes that the jury is still out on the S-ICD device. The implant is large and the procedure complicated to perform. Not to mention that the device does not allow pacing and home monitoring.

Senior Analyst Glenn Novarro of RBC Capital Markets however believes that even though the implant is large and the procedure complicated, doctors are confident that they will be able to perform the procedure easily with each additional procedure. As with any new technology, the learning curve is steep initially.

Novarro, who doesn’t cover Biotronik and wasn’t aware of the Lumax DX System’s approval, believes that while the company may be able to win some traction in the marketplace with a novel device, it has an uphill task.

And that’s because of the overall position of the company in the U.S.

“Biotronik has a very small presence in the U.S.,” Novarro says. “They didn't allocate a lot of resources to the United States many years ago. So they have been consistently trying to catch up. What they have been doing for many years in the U.S. is that if they can poach a good rep from Medtronic in Philadelphia, OK good. It's kind of a shotgun approach.”

The problem now is complicated by the fact that hospitals and providers are consolidating vendors. With few exceptions, doctors believe that there is little differentiation between these products and so they are choosing to have one or two vendors, Novarro said.

“If you go to a big teaching hospital, they have Medtronic, St. Jude and Boston Scientific on the shelf. If you are lucky, maybe they will have a Biotronik. That's at a big teaching hospital like a NYU or Columbia,” Novarro declares. “But if you go beyond those centers - it's one or two. One [player] is always going to be Medtronic. And I doubt that the number two player in the lab is going to be Biotronik. It’s going to be either Boston Scientific or St. Jude Medical.”

-- By Arundhati Parmar, Senior Editor MD+DI 

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X2 Biosystems is Combating Football Concussions with Data and Devices

Starting in the 2013 season, the NFL is going to have a new tool in its fight against concussions - a neuro test developed by X2 Biosystems to assist in testing players for concussion symptoms. It's all part of X2's comprehensive plan to resolve the concussion issue once and for all using one-of-a-kind devices like its X-Guard mouthguard and X-Patch for impact measurement. But while the devices are certainly exciting in themselves, you can hear the passion in X2 co-founder and CEO Christoph Mack's voice as he emphasizes the real goal of his company. “What we want to do is build the definitive database of head impact exposure across this hugely diverse population and then be able to capture the clinical outcomes associated with that exposure to head impact and enable the research community to make real strides in understanding what kind of conditions lead to what kind of injury profiles,” Mack says. “The gizmos are what makes us really unique, but the real mission of our company is this database.”

 The X-Guard 
image courtesy X2 Biosystems
With no currently established standard or threshold as to what type of impact can actually cause a concussion in a player, the X2 team believes the most important task at this step is to gather clinical data – to create a dataset large enough that could make creating these sorts of thresholds possible. Co-founder and chief marketing officer, Rich Able, is quick to clarify that the X-Guard and X-Patch are impact sensors – not intended to diagnose any condition. “We're actually just giving clinicians and athletic trainers data,” Able says. “There is no known threshold. Everyone is different. That's why clinicians are excited because we're going to be supplying millions of hits for them to analyze”
 
While giving all of the appearance and function of a mouthguard, X2's X-Guard is a sophisticated piece of technology able to measure impact to a player's skull and wirelessly transmit this data to a tablet or computer for monitoring. Using X2's software, a trainer or clinician on the sidelines can view realtime data the instant a player takes a hit. The data can then be stored and compared over time. Using the data, combined with tests such as the Sport Concussion Assessment Tool (SCAT), clinicians and trainers can then proceed toward a proper diagnosis.
 
“It's the repeated blows to the head that add up over time,” Able says. “If you see the hits add up at alarming rates, assessments by the clinician or athletic trainer can begin. They will ask questions and compare baseline tests of the individual from months prior and they’ll be better informed on what steps to take next.”
 
It was 2007 when Able first came face to face with the need for better impact sensing technology for sports – when his middle son, Kyle, took a bad hit at a high school football game. “I'm sitting there videoing this, watching my son not moving, and it just took my heart away,” Able recalls. Kyle recovered, but there were notable changes in the following months. Teachers reported he was having difficulty concentrating, complained of blurred vision, and of the bright lights in the classrooms. His family noticed behavioral changes in him as well. “Let's put it this way,” Able says, “The three years of varsity football - we're talking about 1500 hits to the head every year. This kid was an honors student all through ninth grade. When he got out of high school he was around a 2.6 GPA.”
 
It was Able's experience with his son that showed him the real need for an early warning system, something to monitor the hits that kids were taking on the field. He approached Mack with the idea and the two started X2 Impact (now X2 Biosystems) in 2009.
 
Developing the technology for this early warning system fell on Mack. “I started where I think anybody would, which is that the helmet is protecting these kids' heads so let's stick a sensor in there,” he says. But he soon discovered that helmet-based sensors were not ideal. “Sensors in the helmet were a fantastic way of figuring out what the helmet was experiencing; not such a great way of describing what the squishy stuff inside was experiencing. I become vary interested in how to bridge that gap. How do you get out of characterizing what protective gear is doing and toward what the human being is actually experiencing?”
 
He found the answer when he started thinking about the human jaw. “The upper jaw is essentially the skull exposed, right?” Mack reasoned that their sensor and telemetry technology could be miniaturized to fit into an otherwise normal protective mouthguard. Working with ST Microelectronics, X2 was able to develop a 6-axis accelerometer and proprietary wireless protocol that lies at the heart of the X-Guard. Using what X2 calls a virtual projected sensor (VPS) system, the X-Guard senses acceleration relative to the position of the players head and uses this data to determine impact.
 
X2 also had to create its own proprietary wireless protocol to deal with some of the challenges inherent in what it was trying to do. Among other challenges,there was power/battery life considerations, the challenge of minimizing and compressing waveforms, minimizing the payload over air, and tuning the antennae to the right range – too little range is ineffective while too much range eats up battery. “We also have to take into the account things like the fact that human beings are highly absorptive of radio energy. So if we've got one X-Guard or X-Patch at the bottom of a pile of 22 football players it has to do a very different thing than say a Bluetooth headset talking to your phone. So we've had to craft every single aspect of the radio protocol around government regulations and the specific needs of athletics.” Mack says.
 
 The X-Patch 
image courtesy X2 Biosystems
X2's latest the development, the X-Patch could be seen as the next step in its sensing technology, but it was developed very much by accident. “Our very first prototype of the patch was literally a X-Guard strapped to the back of an athlete's head,” Mack says. “ We said, 'Let's just try it out and see how it works, all we have to do is change some of the parameters of where the target - in this case the brain - is relative to the device” The X2 team found that using the same VPS technology afforded a lot of freedom to place sensors anywhere on the target. The X-Patch, which is smaller and designed to unobtrusively adhere to a player's neck, does just this. “We can outfit an athlete with multiple devices and simply because we know where they are relative to the center of gravity of the head we can generate the same answers from all of them.” Ultimately, players being will be able to choose a form factor (mouthguard vs. patch, for example) based on comfort preference.
 
This degree of versatility becomes especially important as X2 branches out beyond sports into other arenas including industrial and military applications. Mack notes that everyone from construction workers to soldiers could benefit from X2's sensing technology. And as their dataset grows larger, so do the potential applications. “It's our belief that only by building a database of head impact exposure, and the subsequent clinical outcomes, diagnoses, therapies, recoveries, and return, when we have that full comprehensive picture, that's when human kind really understands and solves this concussion problem.”
 

-Chris Wiltz, Associate Editor, MD+DI
Christopher.Wiltz@ubm.com 

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J&J Loses Transvaginal-Mesh Lawsuit

Johnson & Johnson, a global healthcare giant based in New Brunswick, New Jersey, lost a product liability lawsuit surrounding its transvaginal mesh implants manufactured by Ethicon, a subsidiary of the company. This latest ruling against the company follows a disclosure that J&J is facing an investigation in 42 states regarding the marketing practices of its mesh implants. A New Jersey jury ruled in favor of Linda Gross, a plaintiff who received a transvaginal mesh implant manufactured by Ethicon. Gross alleges that her physicians failed to warn her about all the potential risks of the device. In the lawsuit, Gross alleged that the device left her in chronic pain. As the case stands, Ethicon will be required to pay out $3.4 million in damages. However, the company plans to appeal the ruling. Sheri Woodruff is the communications vice president at Ethicon Surgical Care. In remarks shared with the press, she said, "We will present evidence to the jury ... in the punitive phase of the trial, which followed a mixed verdict by the jury." She continued, "While we are always concerned when a patient experiences medical conditions like those suffered by the plaintiff, all surgeries for pelvic organ prolapse present risks of complications." The implications of this case could spell dire news for Ethicon and other companies that manufacture transvaginal mesh implants. As of now, approximately 1,800 related cases are on the New Jersey docket alone. Ethicon's surgical meshes, of which transvaginal mesh is an example, saw a spike in adverse events in 2012. References www.sec.gov/Archives/edgar/data/200406/000020040613000038/ex13-form10xk20121230.htm www.reuters.com/article/2013/02/25/usa-jj-vaginalmesh-idUSL1N0BL4F120130225

On Medical Device Tax Repeal, Erik Paulsen Asks Medical Device Community for Help

“The question must now be asked: What is driving these jobs away? The answer is a new $30 billion tax on medical devices in the president’s new health care law. It’s a 2.3 percent tax on revenue, not profit, and equates to a $30 billion burden being placed on the backs of medtech companies around the country.” —Representative Erik Paulsen (R-MN)

Representative Erik Paulsen wrote these words to the LinkedIn Medical Devices Group today. The congressman’s note is the latest in an unrelenting effort to repeal the device tax. It comes on the heels of Paulsen’s latest piece of legislation produced with Ron Kind (D-WS) introduced to repeal the tax. In his letter to the online group, Paulsen reported that H.R. 523, the Protect Medical Innovation Act has gained 187 cosponsors.

“What is amazing is the noise I’m hearing about the device tax,” says Joe Hage, who leads the Medical Devices Group on LinkedIn. “I’m continuing to see a groundswell, despite the notion that a repeal seems doomed. Maybe it’s my own echo chamber, but it seems to me that industry just will not go quietly into the night.”

Hage said he has seen increased interest in repealing the device tax, noting that his grassroots advocacy Web site, no2point3.com, has more than 9500 signatures.

And that sort of support is exactly what Paulsen asks from Device Group members. We need your help in making this legislation a reality,” he says, asking readers to find their own local representatives on the House cosponsors and Senate cosponsors to thank them for support, or to ask them why they haven't signed on. ?

“It is essential that U.S. medical device manufacturing remains a vibrant, innovative, and successful industry that employs thousands of Americans,” Paulson concludes. “The President and Congress have an opportunity to help American manufacturing by working together on pro-growth policies that will prevent jobs from going overseas and help create new jobs here at home.”

While I applaud Paulsen’s efforts, some lingering questions remain. Why, for example, has he introduced standalone legislation, particularly, as Hage points out, “Obama has stated he will not sign such a bill if it comes across his desk.”

In the face of such combative language from the President, wouldn’t it seem prudent to try tactic that doesn’t take such a head-on stance? I’ve heard others, such as Advamed’s Dave Dvorak mention bundling a repeal of the device tax along with several other packages to promote innovation.

If Obama really does support innovation, wouldn’t it be a wise strategy to provide an innovation package so sweet, he couldn’t help but sign it? I would love to hear that Paulsen’s plans don’t end when this latest H.R. bill—which right now has a 2% chance of passing—goes down.

Read Paulsen’s letter in full at http://medgroup.biz/Paulsen
 

Heather Thompson is editor in chief of MD+DI.

 

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An FDA Innovation First: Medtronic Gains Approval to Conduct Feasibility Studies for Cardiac Device

An FDA Innovation First: Medtronic Gains Approval to Conduct Feasibility Studies for Cardiac Device

FDA’s Early Feasibility Medical Devices Clinical Studies program, meant to speed up the regulatory review process of innovative medical devices, has spawned its first graduate.

Medtronic announced Tuesday that it has received the first FDA approval to conduct an early feasibility study of its Native Outflow Tract Transcatheter Pulmonary Valve. It is a minimally invasive device aimed at people with congenital heart disease who don’t have the requisite conduit to maintain proper blood flow between the right ventricle and the pulmonary artery.

“The approval of this study is an excellent example of how the FDA and manufacturers can work together to advance medical innovation by studying initial device design and functionality, with the long-term goal of delivering novel therapies to patients in need,” said John Liddicoat, senior vice president of Medtronic and president of the Medtronic Structural Heart Business, in a news release. “In this case, the early feasibility study will help us develop a minimally invasive therapy for patients whose only current treatment option is open-heart surgery.”

The Early Feasibility Medical Devices Clinical Studies program has its roots in a 2011 draft guidance at a time when the FDA and Jeffrey Shuren was looking for ways to change an image of an agency that industry has long complained of being slow to understand innovation and approve new products. ()

Medtronic has another device aimed at treating aortic aneurysms in the FDA program. That device is part of the company’s Endovascular Therapies business, explained Tracy McNulty, a Medtronic spokeswoman.

On Tuesday, an FDA spokeswoman could not immediately respond to a query about what other devices are part of this program. Previously, when Medtronic announced that its aortic aneurysm device was part of the pilot program, along with eight other devices, the agency cited confidentiality agreements as a reason for not identifying those companies and their products.

—Arundhati Parmar, Senior Editor, MD+DI

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FDA’s Unique Device Identifier Program is a Prince Masquerading as a Frog

 FDA’s Unique Device Identifier Program is a Prince Masquerading as a Frog

In popular lore, the princess kissed the frog to break the spell that had once transformed a handsome prince to that hideous creature.

In the device world, manufacturers need only to embrace FDA’s onerous unique device identifier (UDI) program to know that a golden opportunity lies within.

 

 Under this program, most medical devices will bear a unique label/ID that will contain a host of vendor and provider-inputed data that will reside in an FDA database. The UDI system, FDA hopes, will ultimately boost patient safety and help in recall efforts.

If that doesn’t sound too exciting, then feast on this: if developed correctly, the UDI system can also help device makers have better inventory control, save on regulatory costs and develop better products. And that is the proverbial frog turning into the handsome prince.

The final regulation is expected sometime in mid 2013. Waiting later than now – some would argue it is quite late already - to develop the processes and indeed the culture needed to successfully develop a UDI program would be unwise.

But first, one impression of the program needs to be immediately dispelled: that it is a mere labeling project.

“Complying with UDI is not a labeling exercise,” declared Karen Conway, executive director, industry relations at GHX Inc., a healthcare supply chain management company.

So how should one approach it? Conway provided some pointers.

Cross-functional UDI Team
 

For one, getting different parts of your organization talking. The graphic created by GHX to the left shows developing UDI standards needs input from a cross-functional team involving everyone from legal to IT and marketing to process engineering.

The big question that needs to be answered is: Where and how is data stored within the organization and who owns the data? That’s because UDI isn’t simply slapping on a machine and human-readable barcode. It involves submitting product and usage information to a FDA database, so having consistent data about a product is crucial.

But just imagine the benefit of achieving this Herculean task? If providers are using the UDI appropriately, then manufacturers can know when a particular product was used and how. If the UDI gets captured in the medical record, then providers can have better understanding of how the products are being used, so they can make better, more timely purchasing decisions.

And that in turn means that device makers will have improved inventory control and there won’t be that excessive waste in the medical device industry where products that get made expire before they can be used. Conway described that as a “huge cost.”

The other advantage is simply saving money in the area of compliance because now device manufacturers will have a standardized internal process. Conway said that many organizations identify a product and therefore its attendant data and processes differently through its entire lifecycle.

The UDI data captured in a medical record for instance can tell product development experts which product has better outcomes. That could be leveraged to conduct comparative effectiveness research and thereby build better products.

“If a manufacturer approaches the UDI in a very holistic fashion and approaches this as an opportunity to get its regulatory master data in order, it can actually deliver value for them.”

In other words, immerse yourself in the frog’s world and then muster up the courage to embrace it. You might be surprised.

—Arundhati Parmar, Senior Editor, MD+DI

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In 5 Years, Medtech Firms Will Outsource Design, Legal, and Regulatory Services Over Manufacturing, Report Finds

The medical device industry is heading into an era of change and uncertainty. Device OEMs are grappling with pressures related to cost, time to market, and increasingly stringent regulation. To remain competitive, OEMs will turn to outsourcing.

Completed on December 30, 2012, the "Medical Device Outsourcing Landscape Study" surveyed 853 respondents from MD+DI’s readership about outsourcing habits, how those habits may change, and the requirements related to contract manufacturing. The full report results are available for purchase (see sidebar).

Device Industry Threats and Challenges

Key Medtech Outsourcing Numbers

853 

Number of medical device professionals respondents.

47%

Indicated they will focus internal resources on R&D for new product development. 

28%

Said they will increase manufacturing efficiencies for cost effectiveness.

31%

Said paying the Device Tax was a threat to profitability.

* Based on questions asked in the Medical Device Landscape Outsourcing Study, Current and Future Trends: 2013-2018 from MD+DI and ITG Market Research.

A majority (52%) of device professionals identified regulatory pressures as the most concerning issue they will face in the next five years. Regulatory hurdles are particularly worrisome because they can impede time to market, which 49% of respondents also classified as “concerning” or “very concerning.” Factors such as protecting intellectual property and funding R&D also ranked high among respondents’ anticipated worries.

The device excise tax and healthcare reform weigh heavily on device professionals’ minds. This worry is evident in that 30% of respondents characterized the medical device tax as “very concerning,” while 28% echoed the sentiment for Obamacare. Respondents indicated that paying the excise tax poses the most significant threat to profitability during the next five years.

Current Outsourcing Habits

Cutting costs and expediting time to market remain paramount for OEMs. And the majority of them view contract manufacturing as a means of achieving these two objectives. In fact, 62% of respondents concurred that contract services can save cost and time in certain situations, while 29% find them essential to reducing costs and time to market. An overwhelming majority of respondents further reported that their firms opted to outsource at least some projects.

Of the respondents whose firms rely on outsourcing to at least some extent, 48% acknowledged an uptick in outsourcing over the past five years, and 39% reported that the use of contract services has remained the same during that same period.

The Future of Medtech Outsourcing

Looking ahead to the next five years, 41% of respondents predict that their companies will increase use of contract services, while 43% speculate that their outsourcing needs will remain unchanged. There is a notable shift in the types of services that will be outsourced in the future, from primarily manufactring services to legal and idea-driven services. Respondents foresee an increased need for contract legal and regulatory services to help cope with the growing regulatory pressures. The also indicated growth for R&D and design capabilities. In anticipation of such needs, some contract manufacturers have already begun to institute formalized design support services, thereby signaling a shifting focus from production services to services that will help medical device manufacturers weather the challenges ahead.

No conversation about contracting services is complete without discussing the issue of outsourcing to foreign versus domestic partners. Yet, nearly three-quarters of respondents have outsourced projects within the United States (73%) during the past five years, indicating continued support for U.S.-based service providers. 

Companies do continue to seek out low-cost manufacturing options outside of the United States, however. Among those who already outsource in the countries, Russia (69%) and Latin/South America (61%) topped respondents’ lists as the regions they most expect to expand outsourcing activity in the coming years. 

Partnership Expectations

Good vendor relationships are critical to a successful project. Luckily, 65% of medical device manufacturers feel that contract partners meet expectations most of the time. However, digging deeper into these data, the most important aspects of a partnership were also the most challenging to do well (e.g., communication and transparency). The full report identifies those headaches and the top attributes that make partners trustworthy and valuable. 

Dive Deeper

Purchase the full report* for a comprehensive look into this insightful study. The 94-page slideshow format provides indepth information and makes it easy to extract information for company presentations Download the order form or contact Becky Roll, Western Regional Sales Manager, UBM Canon MedTech Group to order the Medical Device Outsourcing Landscape: Current & Future Trends, 2013-2018 Report Interested Price: $499

 —Heather Thompson is editor-in-chief of MD+DI.

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MD&M West: Medical Materials Mecca

The Q-Flo valve connector from Infusion Innovations Inc. is made using Bayer's Makrolon resin.

Readers of MPMN's Medtech Pulse may have noticed that bioresorbable materials took center stage at MD&M West. But there's much more to the world of medical device materials than the admittedly crucial space occupied by bioresorbables and bioabsorbables. Here's a small sampling of other types of medical device materials that were on display at the show.

Medical-Grade Polycarbonate...and More

Bayer MaterialScience LLC (Pittsburgh) took the opportunity presented by MD&M West to unveil a new material: Makrolon Rx2440, a clear, high-flow polycarbonate that provides fast recovery time in color shift. "This new high-energy-stabilization polycarbonate offers good flow and minimal color shift," remarked Bruce Fine, the company's market segment leader, medical and consumer products. Able to undergo gamma or E-beam sterilization, this material can be used in a variety of medical device areas, including IV access, respiratory, surgical, and renal care applications.

"With its outstanding combination of rigidity, toughness, high flow, and unique color-recovery after irradiation, Makrolon Rx2440 polycarbonate addresses two simultaneous trends--designers taking advantage of polycarbonate's high stiffness to design thinner walls and molders requiring ever-more productivity," Fine added.

Weldable Medical-Grade Polymers

Eastman Chemical Company (Kingsport, TN) has rolled out a family of clear medical-grade polymers that has found use in a range of medical device applications, including a continuous vital signs monitoring system from Sotera Wireless Inc., a pneumatic tube carrier from Pevco, and a three-way stopcock and y-connector from A. Hopfer GmbH. Dubbed Tritan, the copolyester is suitable for use in renal applications, intravenous connectors, and cardiac and other surgical devices.

Used in a laser welding application developed by IPG Photonics, Tritan copolyester does not require additives and is not manufactured with bisphenol A, remarked Gopal R. Saraiya, Eastman's marketing manager, medical devices. A clean process, this laser welding application does not result in biofilm generation, and because it involves the use of lasers, no tools come into contact with the medical device material itself, making the process controllable.

Antimicrobial Materials

Sabic's antimicrobial compounds are used to make a variety of medical devices used in hospital settings.

Not to be left behind in the race to develop new medical device materials, Sabic (Pittsfield, MA) took advantage of MD&M West to launch a group of nine antimicrobial compounds that it touts as one of the broadest antimicrobial portfolios in the industry that offers distinct advantages over off-the-shelf concentrates combined with third-party resins.

Suitable for hospital devices, housings, and implants designed for use in the body for 29 days or less, the antimicrobial grades span four product families: Lexan EXL copolymer, Lexan polycarbonate resin, Xenoy polycarbonate/polybutylene terephthalate resin, and polypropylene resins with and without fiberglass reinforcement. Five grades have a high antimicrobial effect while four have a low antimicrobial effect, according to David Wildgoose, Sabic's general manager, North America, Engineering Resins, Innovative Plastics.

Based on silver, the materials are suitable for many applications that require a broad-spectrum antimicrobial agent. They combat a range of pathogens, including gram-positive and gram-negative bacteria, mold, and fungus.

Medtech Moves: New CEOs at Sirona and Tornier

 In this week's news, two new CEO appointments. 

Mergers and Acquisitions

Illumina (San Diego), a maker of products for analysis of genetic variation and biological function, has completed its acquisition of Verinata Health, a maker of noninvasive prenatal tests.
 

Executive Moves

Dental products manufacturer Sirona Dental Systems (Bensheim/Salzburg, Germany) has appointed Jeffrey T. Slovinas its new CEO and Thomas Jetter as nonexecutive chairman. The appointments replace Jost Fischer, who has retired.

Orthopedics manufacturer Tornier (Amsterdam, The Netherlands) has named David H. Mowry its president and CEO. Mowry was previously the company's chief operating officer.

Richard St. Clair has been promoted to the role of vice president of commercialization at molecular diagnostics company Evogen (Lenexa, KS).

 

Have news about a medtech move? E-mail us the details.

Jamie Hartford is MD+DI's managing editor.