As the new year kicks off, it is a good time to look back and review important innovations from the previous year. 2018 saw a number of exciting new medical devices, ranging from implantable stents and artificial lenses to complex programmable glucose monitors and sophistical wearable fetal monitors, which benefited from trends such as cloud-based applications and artificial intelligence (AI).
In this article, we take a look at some of the world’s most promising prototypes or medical devices that entered the market or whose development was announced over the last year.
GORE Carotid Stent
In November, the U.S. FDA approved the GORE Carotid Stent, developed by WL Gore & Associates. This device can be used to reopen narrowed regions of the carotid arteries in the neck that are involved in blood supply to the brain, in order to prevent future strokes. It is used in conjunction with the GORE Embolic Filter, which has small holes that allow blood to flow through but catch larger particles that may break off from the blockage. After the embolic filter is in place, the stent is inserted. Then, the embolic filter is removed, but the stent remains permanently implanted in the artery to support the section of the blood vessel that was opened. In a recent clinical study of the stent, the device was implanted successfully in 265 out of 265 patients (100%), with only six patients suffering a stroke (2.3%). This stent is very promising, especially for patients who have a high amount of blockage and need urgent attention and care.
The GORE Carotid Stent, when used with the GORE Embolic Filter, is promising for the treatment of carotid artery stenosis in patients deemed at high surgical risk for carotid endarterectomy and who meet the specified criteria.
Visian Toric Implantable Collamer Lens (ICL)
Myopia, or nearsightedness, and astigmatism, which most often results from an irregularly shaped cornea, are very common conditions. A recent study found that 30% of the world is currently myopic, and by 2050 it is estimated that 50% of the world will have myopia, with a two-fold increase in myopia prevalence (from 22% in 2000). And a recent report found that estimated pool prevalence of astigmatism affects 27% of the U.S. population. STAAR Surgical Company, a leading developer, manufacturer, and marketer of implantable lenses and companion delivery systems for the eye, received FDA approval in September for its Visian Toric ICL. This artificial lens is permanently implanted inside the eye and is meant to improve distance vision and correct or reduce myopia with astigmatism. With this product, the company is expanding their Implantable Collamer Lens product line for the correction of refractive error in patients with both myopia and astigmatism.
Holographic 3D tissue printing
Prellis Biologics, a San Francisco–based 3D tissue printing company, has developed a holographic 3D printing technology that can create the complex microvasculature and scaffolding that allows human tissue to survive. Prellis’s technology can print with resolutions as small as 0.5 microns and thus supports printing blood capillaries (5 to 10 microns) as well as human hair (75 to 100 microns). With a primary focus on the unmet medical need for transplant-ready organs, this technology could prove revolutionary. Although technical and regulatory barriers remain high in this incredibly complex field, once available, this technology could ensure healthy organs for the more than 90 million people on U.S. organ donation waiting lists.
This video shows real-time printing of a cell encapsulation device that is useful for producing small human cells containing organoids. The structure is designed to be permeable and the size is 200 microns in diameter and can contain up to 2000 cells.
Freestyle Libre Flash Glucose Monitoring System
There are many glucose monitoring systems on the market, but the recently approved Freestyle Libre Flash Glucose Monitoring System by Abbott Diabetes Care offers some distinct advantages. This monitor can be used by adult patients to make diabetes treatment decisions without obtaining a blood sample from the fingertip. It is a wearable sensor that continuously measures glucose levels. The information obtained from the device can be used to determine the patterns in glucose level, and thus, a better treatment strategy can be applied.
MediBeacon’s Transdermal GFR Measurement System (TGFR)
Kidney disease is considered a “hidden epidemic” as it affects over 850 million people globally (twice the size of diabetes) yet often goes undetected. The Transdermal GFR Monitor is a product platform by MediBeacon for monitoring of kidney function. The company describes the product as a real-time, easy-to-use, and cost-effective monitoring system. The product was recently granted breakthrough device status by FDA as a combination product. The device is intended to measure Glomerular Filtration Rate (GFR) in patients with impaired renal function or who are at risk of kidney disease.
The TGFR platform includes an optical skin sensor, a monitor and a proprietary fluorescent tracer agent that glows in the presence of light. An optical skin sensor is placed on the skin (i.e. arm, forehead, chest wall, or sternum) to measure the fluorescence as a function of time, thus providing clinicians continuous real-time measurement of GFR at the point of care with no need for blood sampling or urine collection. MediBeacon is now looking to begin a pivotal multicenter clinical study in the U.S. and Europe.
Delphi: AI tech for brain injury at birth
Brain injury at birth can have a devastating effect, possibly leading to permanent disabilities such as cerebral palsy, epilepsy, or learning difficulties. The SFI-funded Irish Centre for Fetal and Neonatal Translational Research (INFANT), one of the foremost leaders in infant care in Europe, has developed a detection system called Delphi. Based on AI technology, it can help detect the severity of brain damage as soon as possible, thus enabling early intervention and therapeutic treatment.
Boston Scientific’s SpyGlass
Boston Scientific developed a direct visualization system for cholangiopancreatoscopy named SpyGlass. It is designed to optimize procedural efficiency and productivity. The digital sensor integrated with SpyGlass boasts of improved setup, ease of use, and image quality. With a 60% wider field of view, efficient evaluation of ducts with consistent articulation direction and accessory exit point can be made. It also has a dedicated irrigation and aspiration connection that enables greater physician control to efficiently clear the field of view. The SpyGlass DS and DS II Direct Visualization System was cleared by the FDA in July 2018.
The passive fetal monitor “Rubi”
Rubi Life, which jointly won the Digital Health Technology Show’s Start-Up of the Year Award 2018 along with Clinical Science Systems, has prototyped the world’s first passive fetal monitor, called Rubi. This wearable device can track fetal movement in the third trimester, allowing for overall monitoring of a baby’s well-being. With this device, the U.S.-based medical device startup is hoping to help avoid unnecessary stillborn deaths and alert users when their baby is behaving irregularly.
Conclusions
While the medical devices listed here promise hope in the near future for better monitoring, treatment, and prevention of disease, they are just a sampling of some of the innovations in this industry. Stay tuned to learn more about the exciting new medical device developments that 2019 will bring!
