7 Medtech Discovery of the Decade Nominees—CELLSEARCH

CELLSEARCH

The CELLSEARCH Circulating Tumor Cell Test from Janssen Diagnostics was the first diagnostic test to catch and detect circulating tumor cells (CTCs). The technology is used in patients with metastatic breast, prostate, or colorectal cancer. The system's analysis of these CTCs--cells that have come off of solid cancer tumors and are circulating in the blood--is used alongside other clinical information to give patients and clinicians usable information about cancer prognosis.

CELLSEARCH was the first winner of the Prix Galien "Best Medical Technology" award, an honor it received in 2009.

             

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[Image courtesy of JANSSEN DIAGNOSTICS]  

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7 Medtech Discovery of the Decade Nominees—xTAG

xTAG

The Luminex xTAG technology is a proprietary tagging platform used to develop nucleic acid assays. xTAG diagnostic assays run on Luminex equipment are low-cost, accurate, and allow multiplexing in a single reaction, according to the company.

There are now xTAG assays for cystic fibrosis, respiratory viruses, gastrointestinal pathogens, CYP2D6 polymorphisms, and CYP2C19 variants. 

In 2010, the xTAG Respiratory Viral Panel received the Prix Galien "Best Medical Technology" award.

             

[Image courtesy of LUMINEX]  

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7 Medtech Discovery of the Decade Nominees—SAPIEN

SAPIEN

Edwards Lifesciences' SAPIEN transcatheter aortic valve was a first of its kind, offering patients with severe aortic stenosis the chance to receive a new aortic valve without open surgery. While the technology was initially only available to those patients who couldn't undergo an open procedure, the company's later generation SAPIEN valves have been made available to less-sick patients. 

In August 2016, FDA granted approval for the latest generation of SAPIEN, SAPIEN 3 (pictured above) to be used in intermediate-risk patients.

SAPIEN was given the Prix Galien award for "Best Medical Technology" in 2012, a title it shared with Medtronic's MELODY transcatheter pulmonary valve that year. 

             

[Image courtesy of EDWARDS LIFESCIENCES]  

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7 Medtech Discovery of the Decade Nominees—MELODY Transcatheter Pulmonary Valve

MELODY Transcatheter Pulmonary Valve

As the first transcatheter heart valve to receive FDA approval, the MELODY transcatheter pulmonary valve therapy offers valve replacement without open surgery. FDA granted approval to the device in 2010 through its Humanitarian Device Exemption program; it has had CE Mark since 2006. Patients often suffer from congenital heart disease they have had since they were born, so minimally invasive options to treat lifelong pulmonary valve dysfunction are important.

MELODY was awarded the Prix Galien award for "Best Medical Technology" in 2012, a title it shared with Edwards Lifesciences' Sapien transcatheter aortic valve that year. 

             

[Image courtesy of MEDTRONIC]  

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7 Medtech Discovery of the Decade Nominees—S-ICD System

S-ICD System

Boston Scientific's S-ICD System offers many patients cardiac defibrillation without transvenous leads. Leads can come with complications, such as migration and perforation, and attempts to remove leads can be risky too. The S-ICD is implanted subcutaneously and does not contact the heart or veins.

In August 2016, FDA granted approval to the third-generation Emblem MRI S-ICD, an MR-conditional device.

The S-ICD System won the Prix Galien "Best Medical Technology" award in 2013. 

             

[Image courtesy of BOSTON SCIENTIFIC CORP.]  

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7 Medtech Discovery of the Decade Nominees—TREVO XP ProVue Retriever

TREVO XP ProVue Retriever

Stryker's TREVO XP ProVue Retriever is a clot retriever for patients with ischemic stroke. Clinicians can view the retriever under fluoroscopic imaging while performing the clot retrieval. According to the company, this allows for enhanced delivery and placement. The retriever comes in a variety of sizes, including 3x20 mm, 4x20 mm, and 6x25 mm.

The TREVO XP ProVue Retriever received Prix Galien's "Best Medical Technology" award in 2014.

             

[Image courtesy of STRYKER]  

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7 Medtech Discovery of the Decade Nominees—T2Candida Panel

T2Candida Panel

The T2Candida Panel from Lexington, MA-based T2 Biosystems offers fast turnaround on sepsis diagnosis. Rapid treatment of sepsis is important to treatment success. According to the company, the panel, which has 96.4% sensitivity and 99.4% specificity, offers results in hours and doesn't require a blood culture. 

Prix Galien awarded the T2Candida Panel the "Best Medical Technology" award in 2015.

             

[Image courtesy of T2 BIOSYSTEMS]  

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7 Medtech Discovery of the Decade Nominees

7 Medtech Discovery of the Decade Nominees

These seven medtech products have been nominated for the Prix Galien Foundation "Discovery of the Decade" awards. 

The Prix Galien Foundation has named 33 nominees for its "Discovery of the Decade" awards in three categories--Pharmaceutical, Biotech, and Medical Technology. Commercial success and name recognition won't sway the decision. According to the foundation, the final winner for each category will be chosen based on its "record and potential for impacting human health." 

Of the 33 products, seven come from the medtech category. These products are all past winners of the annual "Best Medical Technology" award from Prix Galien. Read on to learn more about each of these medical technology breakthroughs and make up your own mind about which product deserves the award of the decade.

Curious to see which product will win? Winners will be announced by the Prix Galien Foundation at a ceremony on Thursday, October 27. 

 

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[Image courtesy of SIRA ANAMWONG/FREEDIGITALPHOTOS.NET]

 

Abbott Wins FDA Approval for Innovative Glucose Monitor

The Freestyle Libre Pro is able to collect up to 14 days worth of continuous glucose results to help doctors better evaluate how people are managing their diabetes. The good news of the approval comes amid Abbott's continued legal dispute with diagnostics company Alere

Chris Newmarker

Abbott Labs FreeStyle Libre Pro

FDA has approved Abbott Laboratories's hotly anticipated Freestyle Libre Pro continuous glucose monitoring system, Abbott announced Wednesday. 

The Freestyle Libre Pro includes a disposable sensor that is small, round, and waterproof. Placed on the upper arm with an adhesive pad, it is able to collect glucose level data every 15 minutes, providing up to 1340 glucose results for up to 14 days. Glucose is measured in interstitial fluid through a 5-by-0.4-mm filament inserted just under the skin. 

After the 14 days, a doctor is able to quickly download the data off the sensor using the FreeStyle Libre Pro reader. 

"This novel technology provides a solution to the ongoing challenge of the need for complete and dependable glucose data. This data is imperative for not only the doctor, but also for the patient to help them achieve optimal health," Jared Watkin, senior vice president of diabetes care at Abbott, said in a news release

Wednesday overall was a big day for diabetes devices: There was also FDA approval of Medtronic's MiniMed 670G artificial pancreas.

The good news out of Abbott comes amid continued legal wrangling with diagnostics company Alere--which has sued in Delaware Chancery Court to complete a $6 billion merger that Abbott executives no longer appear interested in completing. Mediation has failed, and Alere has now scheduled an October 21 shareholders meeting to vote on the deal, according to a new Securities and Exchange Commission filing. 

Abbott is also in the process of acquiring St. Jude Medical for $25 billion.

Abbott boasts that the FreeStyle Libre Pro is not only easy to use, but also more affordable because it does away with the need for extra recorders, receivers, and transmitters associated with other continuous glucose monitoring systems. Because it is disposable, there are no reusable components that need recharging or disinfecting. Simply wear the FreeStyle Libre Pro for two weeks and then throw away. The doctor's office only needs one reader for multiple sensors. 

"This technology is groundbreaking because continuous glucose monitoring systems for professional use have been long considered a niche, cumbersome, and expensive technology for mostly type 1 patients. The FreeStyle Libre Pro system changes this paradigm not only because of the unique technology but because it doesn't require fingerstick calibration, is easier to use, more affordable, and is more accessible to people with diabetes," Eugene E. Wright Jr., MD, of Duke Southern Regional Area Health Education Center in Fayetteville, NC, said in the Abbott news release. 

Abbott already recieved a CE Mark for the FreeStyle Libre Pro in 2014, and it was approved for use in India last year. 

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

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[Image courtesy of Abbott Labs]

Major Private Payers Step Forward to Give Device Companies Early Input

Major Private Payers Step Forward to Give Device Companies Early Input

Seven major private payers and health technology assessment groups have raised their hand to give interested medical device companies early feedback on clinical trial plans and potential evidence requirements.

In what is akin to an expansion of the Parallel Review program, CDRH has publicized the names of seven private payer and health technology assessment (HTA) organizations who have volunteered to help medical device companies gain more insight into clinical evidence needed for reimbursement coverage.

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Those seven organizations are:

  • BlueCross BlueShield Association
  • Duke Evidence Synthesis Group, Duke Clinical Research Institute, Duke University
  • ECRI Institute Headquarters
  • Humana
  • Kaiser Permanente
  • National Institute for Health and Care Excellence (NICE)
  • SelectHealth/Intermountain Health

A common complaint from industry is that reimbursement, not regulatory approval, is the real challenge in bringing new medical devices to market. This effort is intended to give industry more resources to better understand what data and evidence they need to collect for payer scrutiny. The Parallel Review program already allows medical device companies to simultaneously consult FDA and CMS about a new device--this brings private payers to the table.

As MD+DI reported earlier this year, CDRH asked private payers for their interest in participating in this effort. The expansion of the Parallel Review program, managed by CMS and CDRH's Payer Communication Task Force, will allow device companies to request that a specific private payer or payers participate in its FDA pre-submission meeting discussion.

An email sent earlier this week notifying companies about the private payer/HTA participation emphasized that this effort doesn't change FDA's regulatory approval process. In addition, participation is voluntary for device companies and the organizations. The list is expected to be updated from time to time with new organizations.

[Image courtesy of STOCKIMAGES/FREEDIGITALPHOTOS.NET]