Editorial | Winners Announcement: Which Medical Device of the Year 2012 | Which Medical Device

 

We received a record number of entries across the categories of Interventional Radiology, Cardiology,Orthopaedics and Anaesthesia and the judges had some difficult decisions to make in determining the winners.  A number of devices reappear each year which is a good indication that manufacturers are listening to clinician feedback. Others are new contenders which clinicians have praised for their innovation and ease of use.  

 

 

Comments and ratings about devices used by clinicians every day are at the very heart of Which Medical Device. Your experiences and views are a valuable resource to fellow professionals as we aim to make Which Medical Device the preferred information website for clinicians, across the world.

 

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Our nominator described this MEDRAD device as a ‘must have’. They said that, “We can achieve a real effective thrombectomy by completely destroying the thrombus. It's ideal for situations where you cannot use rt-pa or urokinase."

 

The judging panel agreed and complimented the Angiojet for being instrumental in removing thrombus in numerous patients with occluded distal arteries, coronary arteries and AV dialysis fistulas and grafts. We would not be surprised to see the Angiojet amongst 2013 nominations. 

 

 

The judges liked the nominator’s reason for putting forward the Scepter C. They described the device as having, “Revolutionised the transarterial embolisation of AVM when use with ONYX.”

 

We regarded the device as an excellent innovative adjunct that increases the safety of embolization procedures.

 

 

The OffRoad is a novel device which our judges felt is worthy of a special award. It provides an alternative solution to the problem of re entering the true lumen during subintimal angioplasty.  This occurs not infrequently and can lead to abandoning the procedure. This new device provides an alternative to the well known outback catheter from Cordis J&J.

 

 

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Our panel were enthused by this device which they described as having the potential to revolutionise treatment of end stage heart failure. 

 

The judges had a difficult decision to make between the LIFEBRIDGE and the SAPIEN (runner-up) and they were swayed by the nominator’s impressive reasoning. They said, “This is the world’s 1st portable Cardiac Assist SYSTEM. It provides life support during the most critical hours that may be utilised without a Perfusionist with placement in critical areas of Transport, ER, ambulance, helicopter or any first responder to a cardio thoracic failure. Plus, certain areas of the hospital for those emergency situations where the Cardiac Bypass Team and Equipment are not on GO!”

 

 

The device was a winner in the cardiology category in 2010 and runner-up for 2011. 2012 sees it take the runner-up award again. Our judges felt that there was no doubt that the SAPIEN is a great product which has been ‘proven to add life to years and years to life’.

 

The SAPIEN was nominated by two clinicians. The first described the device as, "A disruptive technology that will change the treatment of aortic valvular disease."  

Another nominator praised the device saying, “Not only has the SAPIEN valve provided a treatment alternative to thousands of patients in 'aortic stenosis death-row' who had no other option but it did so in an extremely responsible way. The US launch of this device has been conducted in the most rigorous way to ensure patient safety and outstanding outcomes.”

 

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Our judges were unanimous in their support for this device and were impressed by the submission from the nominator who said, “Vidacare has this cool little orange drill that you plop in a sterile bag, attach a special bone needle and drill away into the hardest bone you can find. Works great and gives good core samples. I used one to biopsy and ablate an osteoid osteoma and never broke a sweat. The price is reasonable and there are two kits made to use for bone marrow biopsy and also targeted bone biopsy.”

 

The judges were in full agreement, describing the biopsy needle as a reliable aid to bone biopsy. The motorised needle is easy to control and in our experience produces good quality specimens. This is a simple idea, well executed, which in our opinion makes it our winner in this category.  

 

 

There were two runners-up in the orthopaedic category, this year, with the first being the Triathlon knee - an excellent device with established outcomes. 

The nominator enthused that the device is the, “Fastest growing, lowest revised knee on the market with the strongest least wear resistant poly (X3) along with its single radius design made for the most impactful medical design product in 2012.”

 

The GetAround Knee branding is part of a direct to patient marketing campaign in the USA. We like the Triathlon knee but aren’t aware of evidence that outcomes are better than for other designs, so far as least – hence the device’s position as runner-up.

 

 

The Orthosensor is our second runner up in the orthopaedic category. The nominator’s detailed submission impressed the panel. They said, “The Orthosensor Knee Balancer is revolutionising total knee arthroplasty.  Orthopedic Surgeons generally rely on their experience and intra-operative 'feel' to evaluate whether a knee is properly balanced.  The Orthosensor knee balancer replaces the standard tibial spacer block that surgeons use to position a knee implant.  The OrthoSensor Knee Balancer is embedded with sensors that provide surgeons with actionable data on implant fit and soft tissue kinematics, throughout a full range of motion. The sensors wirelessly transmit key information to a graphic display, enabling surgeons to visualize and quantify joint balance and load.  With this evidence, surgeons can make informed adjustments to the soft tissues to optimize implant placement.  Orthosensor is currently evaluating soft tissue balance and positioning in a multicenter study that is currently ongoing.  Ligament releases that are performed and their effect on knee balance, and sensor data will be correlated to patient specific outcomes.”

 

Our judges felt that this is an interesting device which like the eLibra ligament system and traditional mechanical balancing devices, aims to provide objective intra-operative data to guide the surgeon in balancing the ligaments. If it proves effective in clinical trials, this has the potential to improve outcomes for patients undergoing knee replacement. This makes it a strong contender for device of the year. Unfortunately, we could not find clinical data to prove the efficacy of the device yet so it didn’t quite make our pick of the year.

 

This simple produce caught our judges’ eye. We thought the SaphenaGrip is an excellent, simple idea. They are TED stockings with anti-slip soles, which are said to reduce the risk of falls. Although judges haven’t seen them in use, they agreed that the idea is an elegant and eminently sensible one, deserving of a special commendation.

 

Our nominator described the stocking as, “So simple - just the market-leading Anti-embolism stocking...but with anti-slip dots on the sole, which make it twice as useful, since it helps prevent expensive and painful slips and falls.”

 

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Vidacare was a clear winner of the anaesthesia award. The system is an effective hand-held intraosseous device that solves the problem of gaining intravenous access in difficult pre-hospital and resuscitation situations. Our nominator described the device as having “led the resurgence of Intraosseous access and infusion”.

 

You can read an excellent review on Which Medical Device, by Dr. Ian Nesbitt, a Consultant Anaesthetist (UK) who is also an Editor and member of our judging panel.

 

 

Our runner-up is a device that impressed the judges by its simplicity and high value to clinicians, including those who work outside a hospital environment. Pulse oximeters have reduced in size and cost over the last 30 years from the size of a small suitcase costing tens of thousands of pounds to this small device that can fit on the end of a finger costing less than £100 pounds (sterling). This makes for a device that can be widely used in almost any emergency situation quickly giving a reliable measurement of the patient's pulse and oxygenation.

 

The panel had high praise for the balanced approach of the entry which covered the benefits as well as its lack of a speaker. As a result, the Oxywatch MD300C63 was placed as runner-up and the nomination was declared as the best, therefore winning the nominator a Kindle Fire. 

 

They said, “I find myself using this oximeter more than any other piece of kit I carry when I’m undertaking my work in the Pre-Hospital environment. When working in particularly difficult or hostile environments with an entrapped patient, it can very quickly help you make the decision whether you have time to safely package and extricate them or whether you need to get them out as soon as possible. 

 

The only downside to this device is the lack of a speaker as there is no audible tone of SpO2 and there are no warning alarms if the SpO2 starts to drop. However, as long as you are aware of this and use it for one-off measurements rather than longer-term monitoring, you can’t go wrong with it.”

 

 

The WHO checklist didn’t meet the criteria for being a medical device but because it has a significant impact on clinician practices, our judges felt that it was worthy of a commendation. They agreed with the nominator who said, “It's a simple piece of paper which has the potential to save more lives during and after surgery across the world than any other piece of equipment we will ever see.  And it's completely free.”

 

 

 

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