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Articles from 2016 In September


Ultrasonic Surgical Device Maker Has Potential FCPA Problems

Misonix (Farmingdale, NY) says it voluntarily alerted federal authorities about problems at a Chinese distributor.

Chris Newmarker

An independent Chinese distributor may have been engaging in business practices that violated the U.S. Foreign Corrupt Practices Act, ultrasonic surgical device maker Misonix has disclosed in an SEC filing.

Misonix officials voluntarily alerted the SEC and U.S. Justice Department about the problems.

An internal investigation has ensued at the company. Misonix said in its SEC filing: "The Company intends to cooperate fully with the DOJ and SEC as the investigation continues. At this stage, the Company is unable to predict what, if any, action the DOJ or the SEC may take or what, if any, penalties or remedial measures these agencies may seek. Any determination that the Company's operations or activities are not in compliance with existing laws or regulations could result in the imposition of fines, civil and criminal penalties, equitable remedies, including profit disgorgement, and injunctive relief."

The minimally invasive ultrasonic surgical devices maker has about 80 employees and earned $5.6 million off $22.2 million in revenue during its most recent fiscal year, according to its latest annual report. The company's roots through its predecessors go back to the 1950s.

Chris Newmarker is senior editor of Qmed. Follow him on Twitter at @newmarker.

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New Lab-Grown Blood Vessels Could Be Used in Humans

University of Minnesota researchers have bioengineered blood vessels with the potential to grow and continue developing after being placed inside people.

Kristopher Sturgis

Updated October 3, 2016

University of Minnesota Lab-grown Blood VesselUniversity of Minnesota researchers say they were able to bioengineer blood vessels in a lab from a postnatal donor's skin cells, generating vessel-like tubes that can be implanted into human beings when needed.

The study was led by Robert Tranquillo, professor of biomedical engineering at the University of Minnesota, who told university news that this discovery could be the first of its kind, and could have a significant impact on children who suffer from heart defects.

"This might be the first time we have an 'off-the-shelf' material that doctors can implant in a patient," he said. "In the future, this could potentially mean one surgery, instead of five or more surgeries that some children with heart defects have before adulthood."

Discover more medical device innovation at BIOMEDevice San Jose, December 7-8, 2016.

To create the material itself, Tranquillo and his colleagues combined sheep skin cells in a gelatinous material known as fibrin. They mixed the materials in the form of a tube before rhythmically injecting in nutrients for cell growth using a bioreactor. The bioreactor was also used to strengthen and fortify the tube, and became a key component that enabled the bioartificial vessels to become even stronger than native arteries.

After the vessel was created, the group then used special detergents to wash away all of the sheep cells so that only a cell-free matrix remained.

"When first implanted, our vascular graft is a rather poor approximation to a natural artery. It is a tube of cell-produced collagen and other proteins that possesses stiffness and strength like a natural artery, but it contains little elastin, which normally provides for elastic recoil when blood pulses through, and it has no cells (which we removed, by design), therefore, no  endothelial cells on the inner surface that normally prevent clotting," Tranquillo said.

Tranquillo and his team decided to test the vessel by implanting it in three different lambs to replace part of their pulmonary artery. Upon implantation the lamb's cells began to grow around the vessel, allowing the vessel to grow together with the lamb's tissue into adulthood.

Tranquillo says that this was key for the success of the implanted vessels, as the repopulating of the cells around the vessel graft is what will enable them to grow with the recipient. He was also quick to note that this could be the perfect combination of tissue engineering and regenerative medicine, as they were able to successfully grow tissue in a lab before implanting it, and watching it grow and become a part of the living tissue in the body.

As the sheep continued to grow, the blood vessel graft continued to grow with it. At 50 weeks old, the vessel had increased 56% in diameter, and the amount of blood that could be pumped through the vessel had more than tripled. The group also noted that no evidence of adverse effects such as clotting, vessel narrowing, or calcification could be found.

Tranquillo said that "after the nearly one year implantation in the growing lambs, we observed not only an increase in graft diameter equal to the adjacent artery, but maintenance of strength, presence of substantial organized elastin formed from cells that repopulated the collagenous matrix, and an endothelium--all features consistent with a natural artery."
 
"If these results occur following implantation of our 'off-the-shelf' vascular graft in children who require 'replumbing' of the heart to repair congenital heart defects, they may require only a single open heart surgery in contrast to the multiple surgeries now required to replace the current vascular grafts that do not grow with larger grafts every few years. That would spare the children and families an incredible amount of anguish and greatly reduce health care costs," Tranquillo added.

Creating bioengineered structures that can boost regenerative processes isn't necessarily a new area of research. Last year researchers from the Medical College of Wisconsin developed a new technology comprised of biodegradable microrods that release peptides with regenerative properties that can repair and restore tissue and organ function. Tranquillo and his colleagues hope that their new bioengineered blood vessels could be another building block for regenerative medicine, and perhaps usher in new discoveries.

As for the next steps for the group, Tranquillo says they hope to begin speaking with doctors to get a better idea on how to gain approval from FDA for human clinical trials. In the meantime, the group plans to continue to explore the efficacy of the artificial vessels to improve the success of implantation, and prepare for eventual human trials. 

Kristopher Sturgis is a contributor to Qmed.

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[Image courtesy of University of Minnesota]

Is Medtronic's HeartWare a Problem?

A month after acquiring the LVAD maker for $1.1 billion, Medtronic says FDA has designated two of its recalls as Class I. 

Maureen Kingsley

HeartWare HVAD
HeartWare's HVAD (Image courtesy of HeartWare)

Medtronic says it is making some important manufacturing changes at recently acquired HeartWare amid two recalls that FDA has designated as Class I, the company announced Friday

One worldwide recall initially involved 8799 HVAD controllers--model Nos. 1400 and 1401. The controllers were potentially damaged from exposure to moisture through loose power and data connectors, and hospital clinicians' subsequent inspections have resulted in 308 replacements as of September 26, according to Medtronic. 

The second recall involved 350 unimplanted HVAD pump implant kits--model numbers 1103 and 1104, with serial numbers lower than HW25838--that were sitting in hospital inventory. The pumps in the kits are potentially susceptible to electrical faults and connection failures from fluid entering the driveline-to-controller connector, which could then result in a potentially fatal pump stop. Most of the implant kits, 92%, had been returned as of September 26. 

One patient death reported earlier this year could possibly have been related to one of the controllers involved in the recalls, company spokesman Chris Garland tells Qmed.

Learn about "How to Set Your Connected Health Solution Apart" at BIOMEDevice San Jose, December 7-8.

Both recalls were started prior to Medtronic's acquisition of HeartWare, Garland said. HeartWare sent out a safety notification letter to hospitals around the world between April and June, informing physicians of the potential damage to controllers from exposure to moisture through loose power and data connectors. The letter advised hospital clinicians to inspect patients' HeartWare HVAD controllers for loose connectors at patients' regularly scheduled appointments, and it suggested that clinicians return affected controllers to the company for a replacement at the clinicians' discretion.

Clinicians receiving this letter were also advised to remind patients about the safe use of ventricular-assist devices, particularly when it comes to moisture and proper connection to power and data sources, according to Medtronic. Damage to the controllers from moisture or faulty connections could cause loss of communication between the controller and monitor, a reduced ability to detect alarms, or interruption of circulatory support due to pump stoppage, which could lead to serious injury or death.

HeartWare announced the recall of the implant kits in August. Medtronic's Garland says no deaths have been reported in connection with the implant kits recall.

To fix problems going forward, the epoxy application to the driveline connector of the devices was changed "to reduce the potential for contaminants to enter into the connector to the driveline," Garland said.

Prior to the two HVAD-related recalls mentioned here, HeartWare issued one in January of this year involving some of its LVAD batteries. (FDA announced the recall months later, in June.) The batteries had the potential to lose power prematurely due to faulty cells, according to the notice from FDA, which designated that particular recall Class I as well.

Medtronic acquired HeartWare for $1.1 billion in August. St. Jude Medical, which itself is in the process of being acquired by Abbott Labs, bought another major LVAD maker, Thoratec, for $3.3 billion in October 2015. 

Maureen Kingsley is a contributor to Qmed

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What Has Medtech M&A Meant for Employees?

What Has Medtech M&A Meant for Employees?

This is how medtech employees really feel about recent mergers and acquisitions in the industry.

Another day, another acquisition announcement. The fast pace of mergers and acquisitions in the medtech industry is no secret. But behind the buzzwords like "synergies," "cross-selling," and "optimization," there's little mention of how the medtech professionals at these companies are impacted.

So, we went straight to the source and asked these employees to tell us what recent M&A has meant for their daily work life.

Want more? Check out our free Medtech Salary Survey report, with breakdowns by job description. 

A significant proportion of the people who participated in MD+DI's 2016 Medtech Salary Survey--248 respondents out of 665 full-time medical device and diagnostic professionals, more than one-third of the group--said their organization had been involved in a merger or acquisition in the past 12 months. Many of those professionals were willing to tell us more about how their daily responsibilities, compensation, and benefits have been affected by their company's transaction.

The good news? Most of these professionals said the transaction(s) hasn't impacted their daily responsibilities, pay, or benefits in any way. In some cases, their work life is unchanged because the acquisition affected another part of the business. A few people pointed out that the M&A transaction is still new and its eventual effect on them is still unclear. A couple employees said they were now enjoying higher pay or better benefits without added responsibilites.

Since a big acquisition can raise a company's profile or improve its outlook, many people hope to get a promotion or higher visibility within the organization. A lucky few in our survey noted that they had more responsibility but were also getting paid more for the privilege. "Responsibilities, compensation, and benefits have all increased," wrote one professional. That sounds like a win-win for his or her career and bank account.

On the other side, numerous employees said they are being asked to take on more work without additional compensation or better benefits. As one person put it, they now have an "increase work load; stagnant compensation." Another wrote, "more project to manage, no more pay."

A number of people said that benefits had either been slimmed down or made more expensive. A participant explained, "vacation, training, performance appraisal, medical and dental--all were consolidated under a new, less luxurious structure." Another person mentioned changes to the promotion structure and the way time off is calculated.

Even worse, a few people said they had more to do while their benefits were scaled back. One respondent wrote that he or she now has "more daily responsibilities, compensation flat, and benefits great reduced." One person mentioned that their company no longer offered retirement benefits.

What have these changes done to their job satisfaction? Among the people who were part of organizations undergoing M&A, a lower percentage (27.4%) said they are "very satisfied" with their job than those who aren't part of any transactions (33.1%). Yet a higher percentage of these M&A-impacted employees are either "somewhat satisfied" or "very satisfied" than their peers who aren't taking part in M&A: 77.4% versus 71.7%.

Unsurprisingly, a lower proportion of the group affected by an acquisition in the last year (12.1%) said they felt more job security now than they did 12 months ago when compared to those who hadn't been part of an acquisition (17.5%). But a higher proportion of the M&A group (71.4%) said their job security was "about the same" versus a year ago; 68.4% of the non-M&A group reported feeling "about the same" about job security.

Being busier and feeling underappreciated isn't ideal, of course. But these professionals at least have a job--a couple of the employees in our survey wrote that the M&A may mean bigger changes for them. One explained, "our site is closing soon," while another person wrote that the company is "reduc[ing] staffing."

Perhaps a bit surprising is the observation that going through an M&A hasn't seemed to make employees more willing to look elsewhere for a job. Roughly the same proportion of people in both the M&A (43.2%) and non-M&A group (43.7%) said they were actively looking for a new job or strongly considering a job search.

The bottom line? Mergers and acquisitions are redefining the medtech industry and shaking up the careers of some medtech professionals, for better or worse.  

To add to that conclusion, one person's experience in undergoing an M&A--"Less responsibilities, more compensation and benefits"--sounds like an anomaly that many people could probably get used to.

[Image courtesy of RADNATT/FREEDIGITALPHOTOS.NET]

Designing the Healthcare Experience

Designing the Healthcare Experience

A Philips Design Healthcare leader talks about remaking an entire healthcare environment and experience.

Advice for designing a highly adoptable medical device is not in short supply here at MD+DI. We're covered the topic extensively, including how to develop products for competitive advantage, how physicians have a key role to play in the process, how to take on usability testing, and why designers should consider consumer trends.

As difficult as designing a medical device is, the task looks manageable compared to the challenge Sean Hughes, head of Design Consulting at Philips, undertakes in his role. Hughes and his team design operating suites, hospital wings, and in some cases, entire hospitals.

Learn about "Designing Connected Products for the Entire Care Continuum"   at BIOMEDevice San Jose, December 7-8.

We spoke with Hughes recently about the areas of the hospital that are ripe for new design, what it takes to ensure all stakeholders have input, and how connected health devices have impacted his designs. Read on for more, including the major way he thinks hospitals of the future will differ from today's centers.

Editor's note: This interview has been edited slightly for clarity and brevity.

MD+DI: Tell me about some areas of the hospital that are most in need of design changes.

Sean Hughes: When I think about design, I think very broadly about it because at Philips we have a very wide range of design capabilities which we then bring to clinical spaces to redesign them.

You can think about a hospital--there's the physical building itself, there's the architecture, and there's the interior design, which is quite often in need of refurbishment, repair, or even rethinking. Then you might consider how a hospital actually connects and communicates with its patients. There might be some digital interface, as increasingly patients will be connecting to schedule their appointments online, use their digital tools to connect and manage their medications. There's a whole connectivity part of design that needs to be thought about. And then there's the way care is delivered, where you might think about redesigning the care process as well. Leveraging technology so that we can have patients treated in their home or have patients monitored remotely rather than having to come in, or video connect with them over long distance so that you can make a diagnosis or check their vitals.

When I think about designing in the healthcare space, it's across all of those different areas where as a design team at Philips, we can intervene and help craft a better experience.

When I think about an experience, it has to work for three people in all cases. You've got the patient and the patient's care provider, the healthcare professionals who have to deliver that service, and then you have the business people who run the hospital. So whenever we're designing anything in the healthcare space, we try to take these three stakeholders' perspectives into consideration so that we can create a win for everybody, and not just a win for the administration.

MD+DI: What recent projects has Philips been involved in? We wrote about the team's redesign of an infusion center here.

SH: I think the infusion center is nice because it's not necessarily tied to an awful lot of Philips equipment, but it's about delivering the patient experience.

Now, we're working on projects which range from designing a hospital in the Middle East from the ground up--where it's a greenfield site and they're looking to us to help them conceive what would be a world-class medical tourism destination--which is a wonderful design project and fantastic medical delivery site. That's on a very grand scale.

We just completed a project for which there was a ribbon cutting only [a few] weeks ago in Chicago. It's a new cath[eterization] lab suite that we designed. We installed all the interventional equipment from Philips and we also completely redesigned the recovery bay and the waiting area. We worked on what the experience is like, going from reception to a concierge-type approach. We thought about the whole service delivery on top of providing them with world-class equipment.

That's a very nice example of where the full spectrum of capabilities from Philips has been brought in to develop a total experience for the customer.

MD+DI: How long do these projects usually take?

SH: Just the construction phase alone, if you're building a brand new greenfield hospital, the construction phase can be 18-24 months. You have a whole phase before that, which is, what kind of structures do we want to build, who do we want to serve as a patient population, what kind of clinical programs would be appropriate for the demographic that we're addressing, and how do we want to differentiate this facility from the facilities nearby? So you've got a lot of questions that you need to spend time addressing up front. That's difficult. It's hard to put a timeline on that, because how much research do you want? It's very open ended. Also, it depends on the customer and how well prepared they come to you.

I think the challenging bit is answering the strategic questions up front about what are we building, for whom, how are we going to deliver care, how is it going to be best differentiated, what are the core clinical specialties that we have, and how is this facility going to last and be relevant over time?

MD+DI: What are priorities for each of the three stakeholder groups?

SH: The administrators are very much focused on patient throughput and patient yield. They have been talking more and more about patient experience . . . there are sort of the immeasurable things they are looking for.

I think sometimes the patient experience, when we talk to the patient, is much more qualitative. They want to be seen quickly when they arrive, they want to be calmed by the facility, they want to be sure they're getting attention. It's the more qualitative, experiential things.

Of course, the physical environment should look appropriate. It should look like they expect a hospital to look in many cases, not like a nightclub . . . Friendly, inviting, and comfortable given that who knows what kind of experience they're going to have when they go in.

I think a big frustration a lot of people have is it's just difficult. You have to make and get an appointment, you might get lost when you get there, you can't navigate around the campus, the parking is difficult to find or is on the wrong side of the building. If you think about it as an end-to-end experience and try to design it as such . . . you end up with fundamental problems. Many healthcare facilities have evolved over time and all the departments just have to be where they are because that was the space they had left on the site, but it might not be the best space in terms of flow. The best solution here would be to knock it all down and start again. But you can't do that, so you have to try and find the best compromise.

I think ease of use and pleasure in use, are the sort of qualitative things that patients are looking for. And of course, they want to have a positive clinical outcome.

As for the clinicians, the thing that we try to do is make their life as easy as possible. They have challenging jobs. It can be a stressful environment in the high-pressure role that they have. Making sure that we design in a break room [where] they can relax, they can be themselves. Also, trying to reduce the number of steps that they might take. Sometimes we go in and we realize that if we lay out all the rooms in a particular way, we can reduce the average number of steps they take by 150 or 200 steps a day. They don't have to keep walking to that cupboard over there to get supplies, because the supply cupboard is right next to them, where it needs to be. So they don't need to navigate a very labyrinth approach. If we can reduce the number of steps they might take, fantastic.

We consider acoustic requirements. We can reduce alarms and work on managing alarms and sound absorption. We can also do a lot with lighting. We can make sure the lighting works for the patient and we can offer flexible lighting too.

So there are many things that you can do to try and make their challenging day just a little bit better. But you only find out what you can do by actually engaging them in the design process.

We use an immersive design approach. We go on site and we interview the various stakeholders in an exhaustive way to understand what are their current challenges, bottlenecks, what are the experiences that they're currently delivering. Then we ideate together with them--and we've run workshops and projects where we've had 50 care providers over three days in workshop sessions where we're asking them, how is your work going on today, how are you delivering, what's the handoff between that department and this department, how can we make it better, how can we make it smoother, how can we make it easier for you? Then, we ideate together. We come back based on that input with proposals: Okay, we could do this, we could do that.

I think bringing them into the process and co-creating the solutions with them is a great way to make sure what we deliver is appropriate. They're the people that have to work in it when we leave.

MD+DI: How on board are clinicians with the design input process?

SH: It's like anything, you get varying levels of enthusiasm. In most cases, they really see the benefit, in that we're helping them to design a better work environment for themselves so they can be more efficient, more effective, maybe get less stressed during the day so we can help them do their job better. By helping them do their job better, we're going to help patients have a better experience as well.

Usually, what we try to do is focus on the typical patient. Let's just take some of your typical patients that you might have coming through this space. If you take an emergency department you might have quite a lot of frail, elderly people who frequently end up in the emergency department for non-emergency requirements. Then you've got a mother turning up with a kid with a broken arm. You might have someone else with even more severe trauma. But if we ask them to think about how those typical patient experience workflows work, they get really engaged, because they recognize the patient persona. 

When we bring the patient persona in as the trigger for the conversation around the experience they'd like to deliver, they get really engaged because they recognize them.

MD+DI: I know Philips recently started selling connected health devices. What connected health efforts are your design teams working on and what role will connected health play in the hospital of the future?

SH: When a health care network has decided they'd like to treat some of their patient population at a distance, then you need to work out what that care delivery model is going to be. We use our service design skills to map out how to deliver care to all these patients in their home and not have them come to the hospital. What does that process look like? What is the new work that needs to be done?

The nurses may need to be mobile and visit patients rather than wait at the hospital for the patients to come to them, so you have to rethink their job. You want to think about the patient in their home. What kind of tasks are you going to want them to do through a tablet device or connected device? You need to design the on-screen user interface. You also need to design on the enterprise side the dashboard for someone who is monitoring all those patients remotely is going to look at. You might have a thousand patients connected remotely into a healthcare system. Someone has to look through that list and decide who is the most important patient today that I need to either contact, call, check in on? That patient and their home device needs to have the interface that takes them through the simple steps they might need to weigh themself, take their blood pressure, know what medication they have today.

So you need to design the user interface and the device infrastructure as well as the service blueprint. 

MD+DI: What is the biggest way the hospital of the future will be different from today's centers?

SH: So much more of the care that we deliver every day will be delivered remotely. You'll be able to talk to your doctor and he will be able to check your vital signs remotely. You just won't have to keep going to the hospital for every intervention. If you don't have to keep going for every intervention physically, but they can virtually get you there, then you don't need such a big space for clinical care. But what you might need is a much bigger space for doctors . . . They will do their jobs in a slightly different way. I think if you imagine a hospital today might have 600 beds, they could arguably in the future treat the same patient population with the same clinical program with a lot fewer beds. I think that's going to be the significant difference. It's going to be much more remote and hopefully much more connected.

MD+DI: Any final thoughts?

SH: Design has been a bit misunderstood. Always it's the application side of it, the output that people consider when they think about design. To me it's much more about process and about experience and then the output comes naturally. 

[Image courtesy of ARTUR84/FREEDIGITALPHOTOS.NET]

CellSearch (2009 Prix Galien USA Winner)

    Arrow  backCellSearch

CellSearch (2009 Prix Galien USA Winner)

CellSearch from Johnson & Johnson's Janssen Diagnostics is the first and only actionable test for detecting circulating tumor cells in cancer patients. Detecting such CTCs is important because their presence indicates decreased odds of survival for metastatic breast, colorectal, or prostate cancer patients, according to Janssen. The tests, then, are an important new tool in the toolbox in the fight against cancer. 

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[Image courtesy of Janssen Diagnostics]

xTAG (2010 Prix Galien USA Winner)

    Arrow  backxTAG

xTAG (2010 Prix Galien USA Winner)

xTAG uses a proprietary universal tag system that its owner Luminex (Austin, TX) says is able to provide easy development and optimization of nucleic acid assays. Luminex xMAP systems employ lasers or LEDs to read color-coded microspheres that attach to specific nucleic acid sequences. The result is flexible, accurate, low-cost genetic and infectious bead testing. xTAG assays are presently available for diseases ranging from cystic fibrosis to respiratory viruses. 

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[Image courtesy of Luminex]

Transcatheter Valves (2012 Prix Galien USA Winner)

    Arrow  backEdwards Sapien 3

Transcatheter Valves (2012 Prix Galien USA Winner)

The Prix Galien USA award for medical devices actually went to two devices in 2012: Edwards Lifesciences's Sapien TAVR and Medtronic's Melody transcatheter pulmonary valve.

Both devices represent the promising field of transcatheter heart valves. The valves so far have been reserved for patients at high risk of traditional open heart surgery. But their use is expanding. Edwards's Sapien 3 valve this year became the first TAVR valve to receive an expanded FDA indication that included patients with intermediate risk of dying or suffering serious complications during open-heart surgery, versus the previous indication for only high risk patients.

The next frontier for the technology? It's transcatheter mitral valve replacement.

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[Image courtesy of Edwards Lifesciences]

S-ICD System (2013 Prix Galien USA Winner)

    Arrow  backBoston Sci Emblim MRI S-ICD

S-ICD System (2013 Prix Galien USA Winner)

Boston Scientific's S-ICD technology places a pulse generator and electrode just under the skin, leaving the heart and blood vessels untouched and reducing complications associated with conventional ICDs. The latest version of the device, the Emblem MRI subcutaneous implantable defibrillator, received FDA approval last month.

Boston Sci executives have reported strong growth in sales of the devices. Medtronic is now trying to compete with its EV-ICD (EV for extravascular) technology in which leads are outside of the heart and veins but under the rib cage. 

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[Image courtesy of Boston Scientific]

Trevo XP ProVue Retriever (2014 Prix Galien USA Winner)

    Arrow  backStryker Tevo

Trevo XP ProVue Retriever (2014 Prix Galien USA Winner)

Launched in 2014, Stryker's Trevo XP ProVue Retriever expanded the company's ProVue Retriever line with additional size and shape options for physicians, encouraging ease of use.

Evidence continues to pour in that clot-removing devices such as the Trevo have revolutionized treatment of stroke patients. A study out of Loyola University this year found the Trevo, as well as the Medtronic Solitaire stent retrievers, did a much better job removing clots from blood vessels in the brain than older technologies. 

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[Image courtesy of Stryker]