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April 23, 2017

BD to Acquire C.R. Bard

Becton, Dickinson and Company (BD) and C. R. Bard announced a definitive agreement under which BD will acquire Bard for $317.00 per Bard common share in cash and stock, for a total consideration of $24 billion. The agreement has been unanimously approved by the Boards of Directors of both companies. The combination will create a highly differentiated medical technology company uniquely positioned to improve both the process of care and the treatment of disease for patients and healthcare providers. The transaction will build on BD’s leadership position in medication management and infection prevention with an expanded offering of solutions across the care continuum. Additionally, Bard’s strong product portfolio and innovation pipeline will increase BD’s opportunities in fast-growing clinical areas, and the combination will enhance growth opportunities for the combined company in non-U.S. markets.


This is one of the largest acquisitions in medtech history and the third medtech acquisition worth over $20bn in the last three years, following Abbott's $25bn acquisition of St. Jude Medical in 2016 and Medtronic's $43bn blockbuster acquisition for Covidien in 2015.


See more information on Becton Dickinson and C.R. Bard on Meddevicetracker.


April 24, 2017

Nemaura Medical Announces Development Milestone for sugarBEAT

Nemaura Medical announced the successful completion of the development and testing of its second-generation sugarBEAT wireless skin-patch as a non-invasive, needle-free Continuous Glucose Monitoring (CGM) system for use by diabetics. The company announced clinical trials on the second-generation sugarBEAT wireless skin-patch will be underway soon with a view to submitting CE approval mid-year.


Nemaura Medical expects to launch sugarBEAT in Europe later this year through its European licensee. The daily-disposable format of the sugarBEAT skin-patch is expected to provide a much more flexible way for diabetics to better manage their glucose levels. Furthermore, sugarBEAT’s cost-effective design, consisting of a reusable Bluetooth-enabled body-worn transmitter containing a low-cost disposable adhesive skin-patch will make CGM more affordable, especially for non-insulin-injecting diabetics.


See more information on sugarBEAT on Meddevicetracker.

April 25, 2017

Medtronic Announces Results from IN.PACT Admiral Global Study

Medtronic announced results for its IN.PACT Admiral drug-coated balloon (DCB) with two new sub-analyses from the IN.PACT Global Study in patients with peripheral artery disease (PAD). The new data were reported at the annual 2017 Charing Cross Symposium (CX) in London.


In the sub-analyses in patients with complex lesions, clinically-driven target lesion revascularization (CD-TLR) was 8.5 percent. Similarly, in the sub-analyses in patients with calcified lesions, CD-TLR was 8.5 percent. These results demonstrate the durability, safety and efficacy across PAD patient populations.


The IN.PACT Admiral DCB is an over-the-wire balloon catheter with a drug coated balloon at the distal tip. The IN.PACT Admiral Drug-Coated Balloon originally received FDA approval in December 2014 for the interventional treatment of peripheral artery disease (PAD) in the upper leg and is currently being evaluated in complex patient populations within its PAD indication.


See more information on IN.PACT Admiral on Meddevicetracker.


April 26, 2017

Fife-Year Results Announced from Medtronic’s ENGAGE Registry

Medtronic announced 5-year data from the ENGAGE registry to evaluate its Endurant II abdominal aortic aneurysm (AAA) stent graft system. The results were presented for the first time at the 2017 Charing Cross Symposium in London.


The ENGAGE registry evaluated more than 1,200 patients. The five-year data, which included imaging follow up from approximately 500 of these patients, showed a 97.8 percent freedom from aneurysm-related mortality (ARM) and a compelling 89.4 percent stable or decrease diameter AAA sac at five years. The data demonstrated an 84.3 percent freedom from secondary endovascular procedures.


The Endurant Stent Graft System is comprised of two key components: an implantable stent graft (Endurant Stent Graft) and a disposable delivery system (Endurant Delivery System). The pre-loaded stent graft is advanced to the aneurysm location over a guidewire. Upon retraction of the graft cover, the stent graft self-expands to the indicated vessel diameter. During deployment and expansion, the stent graft is intended to form proximal and distal seal zones above and below the aneurysm location.


See more information on Endurant Stent Graft on Meddevicetracker.


Expanded Fantom II Trial Announces First Patient Enrolled


REVA Medical announced the first patient enrollment in the expanded FANTOM II clinical trial. This arm of the trial is evaluating the safety and effectiveness of the Company’s Fantom bioresorbable scaffold in complex cases that include multiple vessels and long lesions; up to 50 patients will be enrolled in Germany. The primary endpoint is the rate of Major Adverse Cardiac Events (MACE) at a six-month time point.


The FANTOM II study began in March of 2015. In March of 2017, REVA Medical announced that it received approval to conduct an expanded clinical trial for its Fantom bioresorbable scaffold in Germany to include the treatment of complex cases.


The Company recently announced it received CE Mark approval based on data from the FANTOM II study with patients enrolled between March 2015 and March 2016. The Major Adverse Cardiac Event (“MACE”) rate through six months for all 240 patients is 2.1%, which compares favorably to commercial first-generation bioresorbable scaffolds.
See more information on Fantom Bioresorbable Scaffold on Meddevicetracker.

Braeburn Pharmaceuticals announces Top-Line Data from Schizophrenia Implant Study

Braeburn Pharmaceuticals announced results from a 6-month study of the safety, tolerability and pharmacokinetics of transferring patients diagnosed with schizophrenia or schizoaffective disorder and stabilized on oral risperidone to BB0817 (risperidone) implant.


The trial was designed to demonstrate comparable average plasma concentrations of risperidone and its active metabolite, 9-hydroxy-risperidone between the risperidone implant and oral risperidone. The study enrolled more than 50 patients, diagnosed with schizophrenia or schizoaffective disorder according to DSM-V and stable on a daily 4 mg oral dose of risperidone for at least eight weeks. Enrolled patients received three risperidone implants just under the skin in their upper arm.


The study met its primary endpoints and demonstrated that plasma concentrations of oral risperidone and 9-hydroxy-risperidone were comparable to the plasma levels of BB0817 and remained consistent throughout the 6-month study. Efficacy and safety of the risperidone implant were also assessed. During the trial, 100 percent of patients remained stable with no clinically meaningful change in Positive and Negative Symptom Scale (PANSS) scores from baseline over the course of the six months.


The systemic adverse events were similar to those of oral risperidone and included akathisia (9%), EPS (6%), and anxiety (6%). Implant site pain was the most common adverse event related to the procedure (11%), and was generally mild in intensity. Nearly all (94%) patients who had the opportunity to enroll in an extension phase of the study chose to receive a second set of implants.


This new implant builds on the company’s innovative drug delivery technology that was acquired from Endo Pharmaceuticals in May 2015.


See more information on BB0817 Implant on Meddevicetracker.


April 27, 2017

Myriad and Clovis to Partner on BRACAnalysis CDx for Rubraca

Myriad Genetics and Clovis Oncology announced a companion diagnostic collaboration to support a post-marketing regulatory commitment related to Clovis' PARP inhibitor, Rubraca. Financial terms of the deal were not disclosed.


Under the agreement, Myriad will submit a supplementary premarket approval (sPMA) application under its existing PMA for BRACAnalysis CDx to include Rubraca. The Myriad sPMA submission will fulfill a post-approval regulatory commitment by Clovis Oncology to the Food and Drug Administration (FDA) for Rubraca. In December 2016, Rubraca was approved for women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a deleterious BRCA mutation as identified by an FDA-approved companion diagnostic test. The companion diagnostic test approved with Rubraca does not discriminate between germline and somatic mutations. Knowledge of germline status is important to provide patients appropriate counseling.


See more information on BRACAnalysis Companion Diagnostic on Meddevicetracker.



April 28, 2017

Allergan Completes Acquisition of Zeltiq Aesthetics

Allergan announced it has successfully completed the acquisition of ZELTIQ Aesthetics, a medical technology company behind a proprietary controlled-cooling fat reducing treatment, CoolSculpting. Allergan acquired ZELTIQ Aesthetics for approximately $2.4 billion in cash.


The CoolSculpting System has been cleared by the U.S. Food and Drug Administration, with global IP rights, to affect appearance through lipolysis or reduction of unwanted fat using a patented cooling technology. CoolSculpting is marketed in more than 80 countries with entry into additional markets expected in 2017 and 2018. CoolSculpting works by gently cooling targeted fat cells in the body to induce a natural, controlled elimination of fat cells without affecting surrounding tissue. Body contouring is a $4 billion market opportunity worldwide, and growing.


This acquisition adds to Allergan’s global aesthetic business. The CoolSculpting device addresses the need to remove fat non-invasively.


See more information on Allergan and CoolSculpting on Meddevicetracker.



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