Prix Galien selected the 18 most innovative medical devices in 2021. The selection criteria are as usual. The nominee must be approved by the FDA for marketing within five years and show great potential in improving human health. Another thing worthy of respect for the selection committee is that all nominated products never consider their sales in the market. The selection committee only pays attention to the impact of the product on science and health. This is why Prix Galien is worthy of respect and trust.
Prix Galien selected 18 innovative medical device products as in previous years, covering fields from cardiovascular to ophthalmology, from passive to active. It is a pity that this year, the global medical device boss and second child are not visible in the Prix Galien 2021 nomination list. Last year, the boss HeartWare HVAD was also nominated (it can be said that Prix Galien judges have rarely missed their eyes in recent years). Two-thirds of this year's nominees are also selected for Prix Galien 2020, and many of them are regular customers of MedTF.
The final winner of Prix Galien 2021 will be announced in October. The final winner last year was Abbott’s MitraClip.
Next, MedTF will introduce to everyone one by one the final selected 18 latest products.
01
AcrySof IQ PanOptix
AcrySof IQ PanOptix is developed by Alcon and is used for patients who are undergoing cataract surgery and require a single lens to improve near, moderate, and far vision needs.
AcrySof IQ PanOptix intraocular lens is the first trifocal intraocular lens approved by the FDA. It has become a new type of three-focus intraocular lens based on the four-focus design through the proprietary ENLIGHTEN "Energy" optical technology. It optimizes the middle-distance vision while ensuring the needs of near and far vision, and truly realizes the distance and middle vision. , Near full vision, can help cataract patients to solve the problem of looking far (such as walking, traveling), fancy (such as eating, watching the computer, doing housework), looking close (such as reading, reading the newspaper, looking at the mobile phone, etc.) problems Mirror rate!
AcrySof IQ PanOptix adopts a unique optical design, which enables it to have a light energy utilization rate of 88%, which is currently unattainable in all three-focus intraocular lenses. It provides a strong guarantee for clear vision after surgery! Clinical surveys abroad showed that patient satisfaction reached 96.6%.
AcrySof IQ PanOptix relies on its high clinical effect and high satisfaction. Bringing light to millions of cataract patients, and being selected as Prix Galien 2021 is right.
02
JUVÉDERM VOLUMA XC
JUVÉDERM VOLUMA XC was developed by Allergan. Last year Allergan joined the AbbVie family for $63 billion. JUVÉDERM VOLUMA XC is also indispensable for making Allergan so valuable.
JUVÉDERM VOLUMA XC is a medical beauty product. MedTF seldom paid attention to medical beauty before. But medical aesthetics is a big market with hundreds of billions of dollars, which should not be underestimated, even though it is a mixed bag. However, JUVÉDERM VOLUMA XC has completely established a benchmark in this field, unlike some products that are only for "money" and have no actual value.
JUVÉDERM VOLUMA is the first hyaluronic acid (not) dermal filler approved by the FDA to be used safely and effectively in people of color. JUVÉDERM VOLUMA XC is a viscous gel made of cross-linked hyaluronic acid suspended in a phosphate buffer containing 0.3% lindocaine. It is the first dermal filling gel approved in the United States for deep (subcutaneous and/or periosteum) injections to fill the cheeks to improve age-related facial volume loss.
Most doctors believe that JUVÉDERM VOLUMA XC is better for injection, less painful for customers, softer to the touch after being injected into the skin, and easier to fuse with skin tissues.
Since little is known about beauty products, it is difficult to truly understand the value of JUVÉDERM VOLUMA XC for health and science.
03
PureWick
PureWick is developed by BD. BD and Poco are the biggest winners this year. Both products are selected for Prix Galien 2021.
PureWick consists of two parts: Female External Catheter and Urine Collection System. PureWick allows female patients to perform simple, non-invasive urine output management. The Female External Catheter sucks urine from the patient's body, and finally sucks it into the Urine Collection System. The emergence of PureWick gives patients with urinary incontinence a new choice.
PureWick has been selected by more than 2,000 hospitals and rehabilitation institutions since 2016, and a large number of PureWick has been purchased by patients to use at home. Thereby, the embarrassment of urine outflow during sleep is solved.
04
Venovo
Venovo is derived from BD and is specially designed for venous surgery, aiming to solve venous disease.
For Venovo, it is a double happiness. It has just been approved by the NMPA a few months ago and is now selected for Prix Galien 2021.
The Venovo composite platform pattern design has both high flexibility and strong radial support. It is more suitable for iliac veins under compression, maintaining long-term patency of the blood vessels, and being able to conform to the tortuous veins and blood vessels to improve the patient’s Long-term healing effect.
At the same time, the flared design of the Venovo head end helps the stent better adhere to the blood vessel without being easily displaced, and has a highly visible tantalum mark to help the doctor accurately position the stent in the patient's body.
Venovo clinical studies have shown its excellent clinical effects. Among the 24-month NIVL patients, the first-stage vascular patency rate reached 95.2%, and among PTS patients, the 24-month first-stage patency rate reached 73.4%.
The high patency rate is also the reason why Venovo was selected for Prix Galien 2021.
05
PK Papyrus Covered
Coronary Stent System
PK Papyrus covered coronary stent system is derived from Biotronik
PK Papyrus covered coronary stent system is a balloon-expandable stent graft that can be implanted into coronary arteries through a balloon catheter delivery system.
The PK Papyrus covered coronary stent system is designed to treat coronary artery perforation or heart vessel rupture.
The delivery balloon catheter of the PK Papyrus covered coronary stent system is located at the location of the coronary artery perforation. The balloon is then expanded to expand the covered stent, pressing it against the coronary artery wall and sealing the perforation, while allowing normal blood flow. PK Papyrus covered coronary stent system is permanently implanted in the coronary arteries.
06
HeartLogic
HeartLogic heart failure diagnostic originated from Boston Scientific
HeartLogic heart failure diagnostic is a personalized remote heart failure diagnosis and monitoring device.
HeartLogic heart failure diagnostic uses physiological sensors with high sensitivity and low alarm burden to notify patients several weeks in advance and detect early signs of worsening heart failure.
07
Sentinel cerebral
protection system
Sentinel cerebral protection system originated from Boston Scientific
The Sentinel cerebral protection system is a percutaneously delivered dual-filter embolic protection device designed to capture and remove thrombus and other substances discharged during intravascular surgery.
The Sentinel cerebral protection system features a 6 Fr catheter with expandable proximal and distal filters, a hinged sheath and an integrated handle assembly.
08
Cala Trio
CalaTrio is derived from CalaHealth
Cala Trio is a personalized treatment for severe tremor. Cala Trio is a non-invasive targeted therapy specifically designed to help relieve the patient's hand tremor.
Cala Trio measures specific tremors and sends slight stimuli to the inner and radial nerves that travel to the brain. The stimulation interrupted the tremor of the ventral mid-nucleus of the thalamus in part of the brain.
Cala Trio is a prescription medical device.
09
CustomFlex artificial iris
stomFlexartificialiris is derived from HumanOptics
CustomFlex artificial iris is a foldable iris prosthesis, which is used for medical and aesthetic reconstruction of eyes that are completely or partially aniridia, that is, the colored part of the eye is completely or partially absent.
CustomFlex artificial iris is a customized device that mimics the original appearance of the patient's iris. It is capable of controlled light incidence, has a fixed pupil and an opaque material.
10
Barostim
Barostim is derived from CVRx
Barostim is a device that treats severe heart failure through neuromodulation. Barostim includes an implantable pulse generator (IPG), a stimulation lead and a wireless editor.
BAROSTIM NEO uses the principle of air pressure stimulation therapy to trigger its own hemodynamic regulation system.
The carotid sinus baroreceptor is the body's natural hemodynamic regulation system. Air pressure stimulation therapy activates the carotid sinus baroreceptors, allowing the body to adjust its hemodynamics and improve blood supply. In some cases, the carotid sinus baroreceptors in patients with heart failure are not functioning properly and cannot send adequate physiology to the brain. When the carotid sinus baroreceptor is activated, the stimulation signal is sent to the brain. As feedback, the brain counteracts this stimulation by sending to other parts of the body (heart, blood vessels, and kidneys) to relax blood vessels and inhibit the release of blood pressure-related hormones. The direct effect of this change is to reduce the heart's afterload, increase the cardiac output, and then reduce the heart's workload.
11
Sapien 3 Ultra transcatheter heart valve system
Sapien 3 Ultra transcatheter heart valve system is derived from Edward Sapien 3 Ultra transcatheter heart valve system for alleviating patients with symptomatic heart disease caused by severe natural calcified aortic valve stenosis. The Sapien 3 Ultra transcatheter heart valve system is designed for patients undergoing open heart surgery who may be considered intermediate or higher risk.
12
Magtrace and Sentimag magnetic localization system
Magtrace and Sentimag magnetic localization system originated from Endomag
Magtrace and Sentimag magnetic localization system is a magnetic device system used to provide lymph node biopsy guidance for breast cancer patients who have undergone mastectomy.
Magtrace and Sentimag magnetic localization system includes Magtrace injectable magnetic tracer and Sentimag magnetic sensing probe and basic unit. It helps sentinel lymph node biopsy to determine whether the cancer has spread beyond its original tumor site.
13
iStent inject
iStentinject is derived from Glaukos
iStent inject is an eye implant designed for cataract surgery to reduce intraocular pressure in adults with mild to moderate primary open-angle glaucoma.
iStent inject creates two bypass channels through the trabecular meshwork for multi-directional flow through Schlemm's tubes.
14
reSET 和 reSET-O
reSET and reSET-O are derived from PearTherapeutics
reSET is a 90-day prescription digital therapy for substance abuse diseases. reSET provides cognitive behavioral therapy as a supplement to emergency management for patients over 18 years of age who have received outpatient treatment.
reSET-O is an 84-day prescription digital therapeutic agent for opioid use disorders. reSET-O aims to increase the retention rate of patients in outpatient treatment by providing cognitive behavioral therapy as a supplement to outpatient treatment including transmucosal buprenorphine and emergency management.
Both reSET and reSET-O have related dashboards for clinicians and other medical service providers to view information about the patient's use of the system, including completed courses, patient-reported medication usage, patient-reported desires and triggers, and patient-reported Drug use, compliance rewards, and clinical data entry.
15
Zephyr endobronchial
valve system
Zephyrz endobronchial valve system is derived from Pulmonx
Zephyr endobronchial valve system is an implantable device used to reduce lung hyperinflation caused by severe emphysema in adults.
The Zephyr endobronchial valve system has a one-way silicone duckbill valve, which is connected to a nickel-titanium self-expanding positioner and covered with a silicone film.
Doctors can use a flexible bronchoscope to implant the device and then guide it through the airway to the diseased area of the lungs to expand the healthy parts of the lungs and reduce shortness of breath. When the patient inhales, the valve closes and prevents air from entering the damaged lung.
16
GentleWave system
GentleWavesystem is derived from Sonendo
The GentleWave system is a minimally invasive option for root canal treatment.
The GentleWave system uses advanced fluid dynamics, broad-spectrum sound energy and accelerated chemical action to provide cleaning and disinfection of the root canal system.
17
VersaCross Transseptal Platform
VersaCross Transseptal Platform is derived from Sunnybrook Health Sciences Centre.
VersaCross Transseptal Platform is an atrial septal puncture technology, designed to simplify atrial septal puncture, while further improving the accuracy, safety and effectiveness of atrial septal puncture.
The VersaCross Transseptal Platform includes the VersaCross radio frequency guidewire and VersaCross steerable sheath to realize the ultimate and integrated solution for radio frequency (RF) ablation procedures. It avoids the exchange problem during the atrial septal puncture and improves the accuracy of the atrial septal puncture.
18
ProAir Digihaler
ProAirDigihaler is derived from TevaPharmaceuticals
ProAir Digihaler is a digital life-saving inhaler with a built-in sensor that can detect the use of the inhaler and measure the amount of inhalation.
When the patient inhales, the data from the inhaler is recorded as an event and sent via Bluetooth to the accompanying smartphone app, and the patient can then view the information to share with the healthcare provider.