February 19, 2018
Detroit Medical Center Becomes the First Hospital in Michigan to Offer EluNIR Drug-Eluting Stent
The Detroit Medical Center’s (DMC) interventional cardiology team at Heart Hospital recently became the first in Michigan to offer patients with coronary artery disease a new treatment option for vessels that are difficult to stent because of size and intricacy.
Tamam Mohamad, M.D., chief of cardiology at DMC Detroit Receiving Hospital, treated 60-year-old Haila Alamri, who was experiencing angina, with pressure in her chest, after walking short distances. Mohamad completed the procedure guiding the U.S. Food and Drug Administration (FDA) approved EluNIR stent through a complex, circuitous course of blood vessels to reach and open a main artery that was 90 percent blocked. The three-hour procedure brought the blockage to 0 percent, and Haila Alamri went home the next day.
The EluNIR drug-eluting stent has one of the narrowest strut widths of any FDA approved stent currently available in the U.S. The low-profile stent, with a radiopaque spring tip, makes it easier to maneuver in heavily calcified or intricately curved blood vessels.
See more about the EluNIR Drug Eluting Coronary Stent System on Meddevicetracker.
Synergia Raises €8.1 Million in Series A
Synergia Medical announced that it has raised €8.1 million in a Series A funding round from new and existing investors. The funds will be used to bring Synergia's vagus nerve stimulation device, NAOS, through final testing prior to CE mark submission.
Synergia's NAOS system is a next-generation, small-form, MRI-safe, implanted neurostimulation device which stimulates the vagus nerve. Synergia's novel system incorporates the latest advances in biomaterials, optical components, biosensors, and microelectronics. The wires of a traditional neurostimulator have been replaced by optical fibres and photovoltaic cells at the tip of the fibres to convert monochromatic optical energy to electrical impulses.
Synergia is currently developing NAOS for the treatment of drug-resistant epilepsy and the company is conducting advanced-stage testing of the device ahead of CE mark filing expected in 2019. Synergia will also prepare for regulatory approval in the United States where neurostimulation is increasingly prevalent.
See more about the NAOS System on Meddevicetracker.
February 20, 2018
FDA Grants Humanitarian Use Designation for Nativis Voyager Pediatric System
Nativis announced it has received a notice from the U.S. Food and Drug Administration (FDA) that the Nativis Voyager Pediatric system has been granted a Humanitarian Use Designation (HUD) for the treatment of medulloblastoma, a rare, high-grade glioma in children. This Humanitarian Device Exemption will enable the company to begin commercialization of the Voyager Pediatric in the U.S. to treat medulloblastoma as early as the fourth quarter of 2018.
In April 2017, Nativis announced it had entered into an exclusive license agreement for the development and commercialization of Nativis’ proprietary ultra-low radio frequency energy (ulRFE) technology for the treatment of adults with glioblastoma multiforme (GBM) in the Japanese market with Teijin, a comprehensive Japanese company expanding businesses in high-performance materials, pharmaceuticals, home healthcare, product converting, and information technology.
See more about the Nativis Voyager ulRFE system on Meddevicetracker.
PharmaJet and Genexine Collaborate on DNA Vaccine Development
PharmaJet announced a global license agreement with Genexine for the development and commercialization of DNA vaccines for human applications using the PharmaJet needle-free injection systems. Under the terms of the agreement, Genexine will use both the PharmaJet Stratis and Tropis devices in their Phase I and IIa human clinical studies. The agreement also includes provision for potential expansion to include Phase III studies and commercialization.
Genexine’s product pipeline includes a vaccine for human papilloma virus (HPV) type 16 and 18 associated cervical intraepithelial neoplasia (CIN).
See more about PharmaJet on Meddevicetracker.com
DarioHealth Launches the Dario Blood Glucose Monitoring System on Amazon Prime
DarioHealth announced the launch and first sales of its Dario Blood Glucose Monitoring System on Amazon. Distribution on Amazon strengthens DarioHealth's online retail presence, as it provides its users and potential clients with additional purchasing and shipping options, including shipping via Amazon Prime, as all fulfillment is being managed by Amazon.
In order to use the Dario Blood Glucose Monitoring System, users must download the Dario Smart Diabetes Management app, which is available in the App Store and Google Play Store. With the glucose meter measurements, the app can record and track blood glucose levels. In addition, the app can record carbohydrate intake, insulin medication, physical activity, and comes with a weight log that lets users track their weight over time.
See more about the Dario Smart Meter on Meddevicetracker.
February 21, 2018
Medtronic Introduces MiniMed Mio Advance Infusion Set for People with Diabetes
Medtronic announced the launch of the MiniMed Mio Advance infusion set. The MiniMed Mio Advance infusion set is the newest addition to the MiniMed portfolio of infusion sets. The new infusion set will first be available in selected countries around the world, with plans to expand availability over time.
For people using insulin pump therapy, the MiniMed Mio Advance infusion set has:
- A faster set change with fewer steps
- A user-friendly design that allows for one-handed insertion and flexibility to access hard-to-reach sites such as the lower back.
- No visible needle to reduce the hassle of dealing with needles.
- A built-in insertion device (called "serter") to ensure consistent insertion force.
For healthcare professionals, benefits of the MiniMed Mio Advance infusion set include:
- A new insertion process allowing for easier and faster training and less troubleshooting.
- Easier insertion in hard-to-reach sites, allowing customers to rotate their sites more for improved skin health and insulin absorption.
- No visible needle allowing for a more convenient insertion.
The MiniMed Mio Advance infusion set launched in selected countries in Medtronic's fiscal year 2018 third quarter (November 2017 - January 2018) as part of an initial product introduction period. The MiniMed Mio Advance infusion set will be made commercially available in Canada, Hong Kong and certain countries in Europe in Medtronic's fiscal year 2018 fourth quarter (February 2018 - April 2018) with expanded availability to other countries later in 2018.
See more about the MiniMed Infusion Set on Meddevicetracker.
Three Rivers Medical Receives CE Mark for the Rio Embolization Coil System and Completed the First Ten Clinical Cases
Three Rivers Medical announced it has successfully treated its first ten patients. The Rio Embolization Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The RECS is also indicated for arterial and venous embolization in the peripheral vasculature. The CE Mark, granted in October 2017, allows the Company to market the Rio Embolization Coil System in the European Union and other countries that recognize the CE Mark for commercial distribution purposes.
The Rio Embolization Coil System provides the neurovascular specialist with an embolization coil line complimented by a patent protected visual detachment system. The company is actively pursuing additional regulatory approvals in all key global markets.
The Rio Embolization Coil System is approved in 10 & 18 Standard, Soft, and Ultrasoft coil configurations, ranging in lengths from 22 mm down to 1 mm. The Company plans to commence commercialization through prominent international distributors, in territories that recognize the CE Mark.
See more about the Rio Embolization Coil System on Meddevicetracker.
Aesculap Acquires Dextera Surgical
Aesculap, a subsidiary of B. Braun Group, announced the asset acquisition of Dextera Surgical. Aesculap will oversee operations in Redwood City, CA to continue the manufacturing and distribution of Dextera's products. Financial terms of the deal were not disclosed. This acquisition follows Dextera's bankruptcy filing in December 2017.
Through the acquisition, Aesculap expands its portfolio of solutions for beating heart coronary and video-assisted thoracic surgery. The MicroCutter 5/80 stapler, PAS-Port proximal anastomosis system, C-Port distal anastomosis system and technology portfolio supports Aesculap's growth in the cardio-thoracic surgery market.
See more about B. Braun Melsungen on Meddevicetracker.
February 22, 2018
AtriCure Launches the AtriClip FLEX•V Device in the United States
AtriCure announced that it has launched the AtriClip FLEX•V Left Atrial Appendage (LAA) Exclusion System in the United States. The new AtriClip FLEX•V is the first device of the AtriClip family to offer a clip deployment trigger release. The device also offers an open-ended AtriClip design combined with a tip-first closure mechanism to enable easier navigation and placement in cardiac surgeries. This “V” clip technology builds off the AtriClip PRO•V, which was launched in September 2017 for minimally-invasive surgery (MIS) applications. The AtriClip FLEX•V received 510(k) clearance in January 2018.
AtriCure received its first clearance for a left atrial appendage management device in June 2010. The AtriClip FLEX•V has a rotatable and malleable shaft allowing cardiac surgeons and hospital staff to adjust the AtriClip to adapt to specific patient anatomies. In addition, the new clip opening handle offers a reduced fatigue design to reposition the AtriClip multiple times before deployment to ensure the device is extended beyond the LAA and at the base.
See more about the AtriClip LAA Exclusion System on Meddevicetracker.
Valeritas Announces V-Go Distribution Agreement in Italy with Movi SpA
Valeritas Holdings announced it has signed an exclusive distribution agreement with Movi SpA (Movi) for the commercialization of the V-Go Wearable Insulin Delivery device in Italy for patients with Type II diabetes. Under the terms of the agreement, Valeritas has granted Movi the rights to promote, market, and sell the company's V-Go Wearable Insulin Delivery device to diabetes clinics and patients in Italy.
Valeritas will retain responsibility for product development, regulatory approval, quality management, and manufacturing while Movi will be responsible for sales, marketing, customer support, and distribution activities in Italy.
See more about the V-Go Insulin Delivery Device on Meddevicetracker.