The Galien Foundation presents an annual award for the most innovative medical devices, biotechnology products and pharmaceutical agents. The top 10 innovative medical devices in 2017 according to the Galien Foundation are outlined here.
The Galien Foundation oversees and directs activities in the U. S. for the Prix Galien, an international award program that recognizes outstanding achievements in medical therapies and medical technologies. The Prix Galien was created in France in 1970 in honor of Galen, the father of medical science and modern pharmacology, and includes a committee of prestigious scientists and clinicians. The Prix Galien is regarded as the equivalent of the Nobel Prize in biopharmaceutical and medical technology research.
2017: Top Innovative Medical Devices (in alphabetical order)
BrainScope One (BrainScope Co.)
BrainScope One is an FDA-cleared comprehensive head injury assessment device which enables urgent care physicians to objectively assess brain injuries, including concussions. The device measures and interprets brain electrical activity and neurocognitive function for physicians to make clinical diagnoses. It is handheld, non-invasive and can be used on patients 18 years or older within three days of a head injury.
CardioMEMS Heart Failure Monitoring System (St. Jude Medical/Abbott)
The CardioMEMS heart failure monitoring system is designed for comprehensive heart failure care. The system provides direct pulmonary artery (PA) pressure monitoring using an implantable sensor, patient electronics system and website to manage patient data. Patient-initiated sensor readings are wirelessly transmitted to an electronics unit and stored in a secure website for clinicians to access and review. It is the only FDA-approved heart failure monitoring system. It has been shown to reduce heart failure admissions by 33% over an 18 month period, according to the company.
Evarrest Fibrin Sealant Patch (Johnson & Johnson/Ethicon)
This flexible sealant patch has a mechanical structure for integrated clot formation and is designed for general hemostasis. Thousands of woven fibers and active human biologics work together to stop bleeding in tumor bed, liver resection and aortic reconstruction in three minutes. When applied, blood passes through the patch and clot formation begins at the bleeding surface and within the patch. The adhesives on the patch form a tight physical seal with tissue. The patch is fully absorbed in eight weeks.
Exablate Neuro (Insightec)
This ultrasound device that has been approved the by FDA to treat medication refractory essential tremor patients using non-invasive MR-guided focused ultrasound thalamotomy. It targets and treats deep within the brain through the skull. The transducers focus ultrasound waves to create enough heat to ablate a targeted tissue. When performed, there has been shown to be an immediate and significant reduction in hand tremors.
Juvederm Vorbella XC (Allergan)
This product is a lip filler which adds subtle volume to the lips and smooths vertical lip lines. According to the company, 80% of people who receive the treatment have improved satisfaction with their lips one year later while 75% experience improved satisfaction with vertical lip lines one year later.
Koning Breast CT 1000 (Koning Corp.)
This system takes 3D images of the breast with spatial resolution and without painful compression. It is designed to help diagnose breast cancer. The patient is exposed to radiation levels in the range of diagnostic mammograms in a rapid 10-second exposure. The Real 3D technology provides isotropic images for the evaluation of tissues from any angle, eliminating overlapping structure.
Omnigraft Dermal Regeneration Matrix (Integra LifeSciences)
This product is an advanced bilayer dermal regeneration matrix that treats diabetic foot ulcers. It is the only FDA-approved product that can regenerate native dermal tissue. The patch has a built-in silicone layer that serves as a temporary epidermal layer and provides immediate coverage for wound protection. Under the silicone layer is a collagen/chrondroitin-6-sulfate matrix that acts as a dermal replacement layer. It is a bioengineered scaffold that promotes dermal regeneration and is designed with a controlled porosity and degradation rate.
Spyglass DS Direct Visualization System (Boston Scientific)
The direct visualization system is used for cholangiopancreatoscopy – the examination of the bile ducts using an endoscope. It is designed to optimize procedural efficiency and productivity with improved setup, ease of use and image quality. A single operator can perform a procedure, and guide devices that can examine, diagnose and treat pancreaticobiliary conditions.
Thermocool Smart Touch SF Catheter (Biosense Webster)
The recently launched SF Catheter will optimize efficiency by cooling at half the flow rate of other irrigated catheters. It is the only approved device that pairs contact force technology with a porous tip. It can be integrated into the company’s Carto 3 System that uses force technology, 3D mapping and advanced navigation capabilities to give active measurements of stable contact force and catheter location.
Watchman Left Atrial Appendage Closure Device (Boston Scientific)
The device can potentially reduce the risk of stroke in non-valvular atrial fibrillation (NVAF) patients. It has been proven to be a safe and effective alternative to oral anticoagulants and can reduce the risk of bleeding with warfarin use. The device is designed to reduce the risk of thromboembolism from the left atrial appendage in patients who have NVAF and who have an increased risk of stroke and systemic embolism.
Reference: “The Most Innovative Medical Devices of 2017″, Danielle Kirsh, Medical Design & Outsourcing, Oct. 20, 2017.