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ProSim 4

ProSim 4 is the first patient monitor simulator to use touch screen technology easing patient monitor safety, quality testing, and troubleshooting significantly. In 60 seconds, it tests ECG, respiration, and invasive and noninvasive blood pressure. Manufactured and submitted by Fluke Biomedical (Everett, WA).
 
 

 
 

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LS-1

LS-1 is a portable intensive care unit combining a physiological monitor, ventilator, infusion pumps, and fluid warmer onto common power and data buses. The single platform is capable of remote monitoring and control for true interventional telemedicine. Manufactured and submitted by Integrated Medical Systems Inc. (Signal Hill, CA).
 
  

 

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King Vision

The King Vision is a portable, battery operated, digital video laryngoscope system that incorporates an integrated, reusable display and choice of disposable blades designed to visualize the airway while aiding in tracheal intubation. Manufactured and submitted by King Systems (Noblesville, IN).

  

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Freedom Portable Driver

The Freedom portable driver is a wearable power supply for SynCardia’s Total Artificial Heart. Weighing 13.5 lbs, the Freedom driver allows stable total artificial heart patients to wait for a donor heart at home instead of the hospital. Manufactured and submitted by SynCardia Systems Inc. (Tucson, AZ). Supply and design credit to Bimba Manufacturing (University Park, IL), Origin Product Development (Maynard, MA), Lynium LLC. (Tucson, AZ), Yarbrough Electronic Sales (Tucson, AZ), Applimotion Inc. (Loomis, CA), and CGI Inc. (Carson City, NV).

  

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endOclear Wiper Device for the Cleaning and Visualization of Endotracheal Tubes

The endOclear is a sterile, single-use wiper that clears away secretions and biofilm from inside the endotracheal tube (ETT) and provides visualization inside the ETT. Manufactured by EndOclear LLC (San Ramon, CA). Entry submitted by Innovative Design LLC (Danvill, CA). Supply and design credit to JG Plastics Group LLC (Costa Mesa, CA), Hiemstra Product Development LLC (San Francisco).

  

 

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Novel Vena Cava Filter Boasts 98% Success Rate in Clinical Trial

Novel Vena Cava Filter Boasts 98% Success Rate in Clinical Trial

In a separate interview with MD+DI,  noted device inventor Thomas Fogarty, MD shares his perspective on the Crux vena cava filter.

The standard treatment for treating PE is to thin the blood with an anticoagulant such as coumadin. Treatment of PE with blood thinners, however, is contraindicated in people with a high bleeding risk. “Such patients are best served with a inferior vena cava filter, which is a device that goes into the major vein that drains the blood from the lower extremities and the pelvic area,” explains Robert Mendes, MD, associate professor of surgery at the University of North Carolina and the chief of vascular surgery at Rex Medical Vascular Specialists (Raleigh, NC). 

The inferior vena cava filter (IVCF) prevents blood clots from travelling into the heart or lungs, where they can interfere with heart and lung function and even cause sudden death. Developed decades ago, newer IVCFs can be delivered using minimally invasive techniques. Temporary IVCFs are also available, which can be retrieved once the risk of PE subsides. 

The general use of IVCFs has increased dramatically in the past 30 years, from approximately 2000 in 1979 to nearly 167,000 in 2007.  In the meantime, a number of clinical problems had been linked to IVCFs. From the time the devices were introduced to 2005, the FDA had received 921 device adverse event reports related to the devices. Although effective at preventing PE, the devices sometimes tilted within the vein, migrated from where they were initially placed, or penetrated the wall of the inferior vena cava.

To address these problems, Crux Biomedical (Menlo Park, CA) has developed a novel IVCF. “The device is basically nitinol wire that is created into the shape of a helical form with the figure 8 shape. The lower portion of that figure 8 is the actual filter portion of it, which is created from an expanded polytetrafluoroethylene (PTFE). And that prevents clots from passing from the lower extremities, from the pelvic area, up into the heart,” he adds. 

Mendes explains that the device does three things well that the other filters on the market have not been able to do:

  1. It has a self-centering design, which prevents tilting within the inferior vena cava. "It is always aimed or angled into the center of the vein, which makes it very easy to grasp and remove, so there is no fear of tilting or no difficulty in retrieving the filter when it comes for that."
  2. The device enables bidirectional retrieval. "You can actually remove this filter from above or you can remove it from a femoral approach from below. There is no other filter on the market that can be removed from two directions," Mendes says. "That will provide a lot of new options for removing the filter that didn’t exist before."
  3. The geometry of the device promotes fixation after placement, preventing migration. Because the device has fewer parts than other vena cava filters, there is less risk of fracture. 

The following animation illustrates how the novel VCF works. It also shows how the filter is deployed and retrieved:   

Exceeding Expectations

In January 2012, a pivotal trial known as the Retrieve clinical study was completed. The trial was a prospective, multinational investigational study that assessed the safety and efficacy of the Crux device as both a retrievable and a permanent device. The study, which was carried out at 22 centers in the United States, Belgium, Australia, amd New Zealand involved 125 patients at high risk for pulmonary embolism. 

Mendes served as the principal investigator of the pivotal trial of the device and worked with FDA to establish guidelines to study it in patients for at least six months. “We were able to supersede all expectations. 96% of the filters we put in were able to function exactly the way they were intended. And by the six-month follow up of the study, no embolizations, migrations, or fractures were observed.”

Also in the study, the researchers attempted to retrieve 54 filters and 53 (or 98%) were taken out successfully. The average retrieval time was 7 minutes. “Of the filters that were taken out, there were no fractures, no defects known or seen to the filter,” Mendes says.

Based on this data, Crux Biomedical expects FDA to approve the device this year. The device received the CE Mark in January 2012. 

Brian Buntz is the editor-at-large of UBM Canon's medical device group. Follow him on Twitter at @brian_buntz.

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Senator Ayotte Calls for Repeal of Medical Device Tax

During a visit last week to a medical device company in Keene, NH, Senator Kelly Ayotte (R-NH) reaffirmed her commitment to repealing the $28.5 billion Medical Device Tax. Senator Ayotte, a member of the Senate Small Business Committee, toured Smiths Medical and spent time meeting with employees and discussing concerns with the Medical Device Tax, which threatens New Hampshire jobs and stands to increase costs for consumers. Medicare's Chief Actuary has estimated that the tax will increase national health costs by $18.2 billion in 2018.

"Medical device manufacturers across the state have told me this tax will make it harder for them to invest and grow, and could result in jobs being lost overseas," said Senator Ayotte following the visit. "At a time when our country needs good-paying, sustainable jobs, the Administration's continued push for a medical device tax makes no sense. I will continue my efforts to repeal this burdensome new tax and the federal healthcare law."

In visits to medical device companies throughout New Hampshire, Senator Ayotte has repeatedly heard firsthand how the tax will stifle innovation and cost jobs.  The visit to Smiths Medical coincided with the two-year anniversary of the federal healthcare law's enactment and comes as the Supreme Court prepares to hear oral arguments challenging the law's constitutionality.

Senator Ayotte is cosponsoring legislation that would repeal the Medical Device Tax, under which medical devices ranging from surgical tools to wheelchairs would face a 2.3% excise tax. A recent study estimates that the Medical Device Tax threatens 43,000 jobs nationwide, and could result in $3.5 billion in lost wages.  New Hampshire is home to about 50 medical device companies employing approximately 3,800 people.

-Richard Park

The Medical Device Tax: Celebrating Two Years of Controversy, Panic, and Layoffs

This past week marked the passing of two years since the controversial 2.3% medical device tax was signed into law as part of the Affordable Care Act. And for most of the medical device industry, it was an anniversary characterized by renewed bitterness and criticism rather than romance and roses.

Set to go into effect in January 2013, the medical device tax has been at the center of a heated national debate that only seems to escalate as the industry's doomsday approaches. In addition to concerted efforts to repeal the tax, the medical device industry and its supporters have emphasized the serious potential consequences associated with implementation of the tax. Among them are large-scale layoffs, relocation of operations out of the country, barriers to innovation, and prices being passed on to consumers—an outcome that negates the purpose of the bill.

And some of these consequences aren't just scare tactics or empty threats. Industry giant Stryker, for example, has already announced plans to reduce 5% of its global workforce as a cost-management measure in preparation for the burdensome tax. Industry group AdvaMed estimates that as many as 43,000 medtech workers could ultimately lose their jobs. A recent analysis by Bloomberg, however, questioned AdvaMed's methodology and results.

With these issues in mind, the medical device industry was sure not to let the tax's anniversary go unnoticed. “MDMA said from the beginning that the device tax would hamper job creation and patient care, and unfortunately we are already seeing this play out as companies plan for what is really a tax on innovation,” said Mark Leahey, president and CEO of the Medical Device Manufacturers Association, in a statement issued on the anniversary.  “As the voice of small and innovative medical technology entrepreneurs, we know of many companies who will be paying more in taxes than they earn in profits starting in 2013.”

Also capitalizing on the anniversary was New Hampshire senator Kelly Ayotte. Ayotte, who is cosponsoring legislation to repeal the tax, spent the day touring Smiths Medical and reaffirming her commitment to repealing the medical device tax. "Medical device manufacturers across the state have told me this tax will make it harder for them to invest and grow, and could result in jobs being lost overseas," said Senator Ayotte following the visit.  "At a time when our country needs good-paying, sustainable jobs, the Administration's continued push for a medical device tax makes no sense. I will continue my efforts to repeal this burdensome new tax and the federal health care law."

Yet despite the steady backlash against the tax and the doom-and-gloom predictions for the medical device industry, a fair portion of medtech professionals continue to hold out hope. In fact, in an online poll that we conducted last month, optimists edged out pessimists with 55% of respondents saying that they thought that the tax would be repealed. With the Supreme Court prepping to hear arguments, one thing is for certain: The rest of 2012 is sure to be eventful. --Shana Leonard

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Weekly Vitals: Covidien Goes on Buying Spree, Why Medical Device Firms Should Listen to Don Draper, and More

Covidien dominated headlines this week as the medical device company made two attention-grabbing acquisitions. First, the company announced that it would purchase superDimension Ltd., a private Israeli company focused on the development of minimally invasive interventional pulmonology devices, for $300 million. The announcement followed a few days later that the device maker would also acquire Newport Medical Instruments, a physician-led company focused on the development of affordable ventilators. In other news, MassDevice recommended that the medical device industry heeds the advice of Mad Men's Don Draper and more negative information surfaces as to DePuy's questionable handling of the metal-on-metal hip implant debacle. Read about these and other top stories of the week in our roundup below.