Every year, the Galien Foundation chooses top products in the medical technology, biotechnology, and pharmaceutical fields to honor with its Prix Galien USA Awards. This year, there are the 11 products vying for the title of 2017 Best Medical Technology Award.
To be considered for the prize, these medical technology products all received regulatory go-ahead from FDA in the past five years and have shown the capability to have an outsized effect on the wellbeing of human patients. Winners will be chosen based on their positive impact on human health.
Learn more about these 11 innovative medical technologies here and look out for the winner to be announced on October 26, 2017 during the Prix Galien USA Awards Ceremony.
[Image courtesy of LEKKYJUSTDOIT/FREEDIGITALPHOTOS.NET]
The ATTUNE® Knee System from DePuy Synthes, part of the Johnson & Johnson family of companies, is designed for knee reconstruction. Various knee technologies are available through the system, including the ATTUNE Fixed Bearing Knee, ATTUNE Rotating Platform Knee, and ATTUNE Anatomic Patella. Earlier this year, data from the National Joint Registry for England, Wales, Northern Ireland, and the Isle of Man showed that at four years, the cumulative revision rate for the ATTUNE Knee was lower than that seen in all total knee replacement procedures (1.3% versus 1.9%).
The BrainScope® One from BrainScope Company received FDA 510(k) clearance in September 2016. The device consists of a disposable headset outfitted with electrodes and a smartphone component that uses machine learning and algorithms. The system takes electroencephalograph (EEG) readings to evaluate the extent of brain damage in patients exhibiting signs of mild traumatic brain injury, and is intended to accelerate assessment.
[Image courtesy of BRAINSCOPE COMPANY ]
The CardioMEMS™ HF System from Abbott is an implant that remotely monitors for signs of worsening congestive heart failure by measuring a patient’s pulmonary artery pressure. FDA approved the system in May 2014. Data from the “CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Patients (CHAMPION)” trial showed a 28% reduction in the heart failure hospitalization rate at six months and a 37% reduction in heart failure hospitalization at average follow up of 15 months.
[Image courtesy of ST. JUDE MEDICAL (NOW ABBOTT)]
The EVARREST® Fibrin Sealant Patch from Ethicon, part of the Johnson & Johnson family of companies, uses human biologics—thrombin and fibrinogen—to create a structure for clot formation to stop bleeding. In December 2012, FDA granted approval for the product’s adjunctive use in specific surgical cases, including open retroperitoneal, intra-abdominal, pelvic, and non-cardiac thoracic surgeries. The agency broadened that indication in October 2016 to cover adjunctive use for general hemostasis in surgeries on adult patients.
In July 2016, the Exablate Neuro from Insightec became the first MRI-guided focused ultrasound device to received FDA approval for treatment of essential tremor. As MD+DI reported last year, the device works by using focused ultrasound to eliminate problematic brain tissue. The technology allows patients who have not experienced relief from medication an option for noninvasive treatment instead of brain surgery.
[Image courtesy of INSIGHTEC]
Juvederm Volbella® XC from Allergan is an injectable gel used to add volume to the lip and fill the vertical lines around the lips in patients over the age of 21. FDA approved the product in June 2016. According to Allergan, results last as long as one year.
[Image courtesy of ALLERGAN PLC]
The Koning Breast CT 1000 from Koning Corporation is a system that uses computed tomography (CT) imaging to help diagnose breast cancer. The system, which received FDA approval in January 2015, does not compress the breast, but instead enables 3D imaging of the hanging breast while the patient lies face down. The technology isn’t used in screening, but is indicated for use with patients who have signs, symptoms, or screening results that warrant further investigation before a possible biopsy.
[Image courtesy of KONING CORPORATION]
The Omnigraft™ Dermal Regeneration Matrix from Integra LifeSciences is used to encourage the growth of skin tissue. According to the company, the product consists of a silicone layer used to shield the wound, and a bioengineered scaffold used to encourage formation of new dermal tissue. Approved by FDA in May 2016, the matrix is indicated to treat certain neuropathic diabetic foot ulcers that have existed for more than six weeks.
The THERMOCOOL SMARTTOUCH® Surround Flow Catheter, the latest generation in the catheter family with a porous tip for even cooling, received FDA approval in August 2016.
[Image courtesy of BIOSENSE WEBSTER]
The WATCHMAN™ Left Atrial Appendage Closure Device from Boston Scientific is an implant used to block the left atrial appendage of the heart, a common area for blood clot formations in patients with atrial fibrillation. The implant, intended to reduce the risk of stroke, received FDA approval in March 2015 with an indication that covers use in high-risk non-valvular atrial fibrillation patients who want an alternative to the blood thinner warfarin.