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September 5, 2017

Teleflex Announces Acquisition of NeoTract



Teleflex and NeoTract announced that the companies have entered into a definitive agreement under which Teleflex will acquire NeoTract in a transaction valued up to $1.1 billion. Under the terms of the agreement, Teleflex will acquire NeoTract for an upfront cash payment of $725 million at closing, and up to an additional $375 million upon the achievement of certain commercial milestones related to sales through the end of 2020. This acquisition is expected to close within the next 30 days.



NeoTract is a privately-held medical device company that has developed and commercialized the FDA-cleared UroLift System, a novel, minimally invasive technology for treating lower urinary tract symptoms due to benign prostatic hyperplasia. 



See more information NeoTract on Meddevicetracker.



EnteroMedics Begins Post-Approval Study of vBloc System



EnteroMedics announced the start of its U.S. FDA post-approval study of the vBloc System, a medical device used to treat obesity. The ReNEW Study (Maestro New Enrollment Post-Approval Study) will evaluate the long-term safety and effectiveness of the vBloc System for weight loss in obese patients in a real-world clinical setting. The first patient in the company's ReNEW Study was enrolled late last week at NYU Winthrop Hospital in Mineola, NY.



ReNEW is a five-year, multi-center trial that will provide 200 patients with vBloc Neurometabolic Therapy at approximately 10-15 centers across the United States. The primary safety objective of ReNEW is to demonstrate that the rate of serious adverse events (SAEs) related to implanting vBloc is statistically lower than 25% at five years.



See more information the vBloc System on Meddevicetracker.



Medtronic Launches Long-Term Study of InFuse Bone Graft in PLF Surgeries


Medtronic announced the launch of a long term clinical study program to collect prospective data on INFUSE Bone Graft in Posterolateral Fusion (PLF) and Transforaminal Lumbar Interbody Fusion (TLIF) spine procedures. The first patient has been enrolled in the PLF study at Fort Wayne Orthopedics in Fort Wayne, Indiana. INFUSE Bone Graft is used with certain Medtronic interbody fusion devices to treat lumbar degenerative disc disease, and eliminates the need to harvest bone from the patient's body in a secondary surgical procedure.



The global clinical program, called B.O.N.E (BMP Outcomes and New Evidence in PLF and TLIF Procedures), is designed to expand the clinical understanding of INFUSE and to evaluate efficacy, safety and health-economic outcomes for use in PLF and TLIF spine procedures. The current plan for the prospective, multi-center, ten-year program will include approximately 40-50 sites and 550-700 patients between the Pilot and Pivotal studies of both procedures. The PLF Pilot dosing study, which will include approximately 125 patients, will be followed by a TLIF Pilot dosing study in 2018.



See more information the InFuse Bone Graft on Meddevicetracker.



September 6, 2017


NuVasive Receives FDA 510(K) Clearance for MAGEC System

NuVasive announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use of the Company’s redesigned MAGEC system with its RELINE Small Stature system, comprehensive pediatric deformity fixation system. 


The MAGEC system uses magnetic technology within adjustable growing rods to treat early-onset scoliosis in a less invasive manner. The latest additions to the MAGEC system include redesigned components to help provide ease-of-use for the surgeon and help make surgical outcomes more reproducible. In addition, the MAGEC system is introducing a new 5.0 millimeter rod diameter offering, that when paired with the low-profile RELINE Small Stature system, is designed to provide optimal strength to growing-rod constructs to help improve clinical outcomes.



See more information the MAGEC System on Meddevicetracker.




September 7, 2017

DarioHealth Launches Its Dario App in the Google Play Store


DarioHealth announced the launch of its Dario app for certain leading Android smart mobile devices (SMD) in the U.S. The company's Dario Blood Glucose Monitoring System (BGMS) is now available and ready to ship its to Android users in the U.S. 


The Dario app is now available in Google Play's U.S. app store for specific Smart Mobile Devices to be used with the Dario Blood Glucose Monitoring System.



See more information on the Dario Diabetes Management Solution App on Meddevicetracker.



Fitbit and Dexcom to Develop Continuous Glucose Monitoring Experience for Diabetics


Dexcom and Fitbit announced a collaboration to develop and market products to help people better manage their diabetes and get a more complete picture of their overall health with mobile tools. 


The first planned initiative is to bring Dexcom CGM data to Fitbit's new smartwatch, Fitbit Ionic. Through this experience, Dexcom CGM users on either Android or iOS devices would be able to see both activity and glucose levels, right on their wrist. The companies are targeting availability as soon as possible in 2018 and will continue to explore opportunities to work together to develop tools and resources aimed at helping people better manage their diabetes.



See more information on DexCom on Meddevicetracker.



September 8, 2017

Cellnovo Provides an Update on the 510(K) Application for the Cellnovo Diabetes Management System


Cellnovo provided an update regarding the review by the U.S. Food and Drug Administration (FDA) of the company's 510(k) application for clearance of the Cellnovo Diabetes Management System. Cellnovo filed a 510(k), a premarket submission that is required before a medical device can be marketed in the US, with the FDA on November 16, 2016. On August 8, 2017, Cellnovo responded to an initial series of questions from the FDA relating to the application. Cellnovo can report that since this submission, the FDA has responded requesting further information to supplement that already provided by the Company. 


The Company expects this new step will extend the previously expected timeline for clearance of the device in the US and will continue to keep the market informed of progress. 



See more information on the Cellnovo System on Meddevicetracker.



Medtronic Receives Japanese Approval for IN.PACT Admiral DCB



Medtronic announced that the IN.PACT Admiral Drug-Coated Balloon (DCB) received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment of peripheral artery disease (PAD) in the upper leg - specifically, in the thigh (superficial femoral arteries (SFA)) and behind the knee (popliteal arteries). Before Medtronic can begin commercialization, it must partner with Japanese MHLW to gain reimbursement to ensure broader access to this innovative and clinically-proven therapy.



The MHLW granted approval for the IN.PACT Admiral DCB based on the robust clinical data from the IN.PACT SFA Japan Trial led by Osamu Iida, M.D. of Kansai Rosai Hospital, Japan and Dr. Yokoi. The study data demonstrated 93.9 percent primary patency in the DCB group as compared to 46.9 percent in the PTA group at one year based on Kaplan-Meier Estimate (p<0.001). Additionally, one-year results demonstrated a CD-TLR rate of 2.9 percent for the DCB group compared to 18.8 percent in the PTA group (p=0.012). In IN.PACT SFA Japan, major adverse events were also lower for the DCB at one year (4.4 percent compared to 18.8 percent in the PTA group; p=0.028), with no major target limb amputations.



See more information on the IN.PACT Admiral Drug-Coated Balloon Catheter on Meddevicetracker.



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