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October 9, 2017

SI-BONE’s MIS SI Joint Fusion Receives Positive Coverage


SI-Bone announced that PEHP Health & Benefits of Utah, a nonprofit trust providing health benefits to Utah’s public sector employees and their families, has issued a positive coverage policy for MIS SI joint fusion with iFuse.



The policy specifies positive coverage for MIS SI joint fusion using iFuse with prior authorization for CPT (current procedural terminology) code 27279 and considers open SI joint fusion with CPT 27280 experimental and investigational. In addition, the policy considers percutaneous radiofrequency ablation/denervation of the SI joint, including pulsed, non-pulsed and cooled, experimental and investigational.



See more about the iFuse Implant System on Meddevicetracker.



BIOTRONIK Begins Enrollment in BIOVITESSE Study


BIOTRONIK announced the start of enrollment of a coronary stent trial aiming at assessing the safety and clinical performance of a new coronary stent in de novo coronary artery lesions. On September 28, first Dr. Marco Moccetti, Cardiocentro Ticino, Lugano, Switzerland, and later on the same day Dr. Lorenz Raeber, University Hospital Bern, Switzerland, successfully implanted the new BIOTRONIK coronary stent in their first patients.



The polymer-free coronary stent combines the proven PRO-Kinetic Energy stent features with its ultrathin struts, with a new anti-proliferative limus drug designed to prevent excessive cell growth.



The BIOVITESSE prospective, multicenter, first-in-man trial will investigate the treatment of coronary de novo lesions. Primary endpoints are strut coverage at one month and in-stent late lumen loss (LLL) at nine months. Strut coverage will be assessed by optical coherence tomography (OCT) analysis. LLL will be assessed by quantitative coronary angiography (QCA) assessment.



The BIOVITESSE study will run in five centers in Switzerland until August 2019.



See more about the BIOTRONIK Anti-Proliferative Limus Coronary Stent on Meddevicetracker.




October 10, 2017

Edwards Announces Published Results Using the FORMA System


The 1-year clinical and echocardiographic results using the transcatheter Forma system (Edwards Lifesciences) for severe tricuspid regurgitation were published by Gidon Perlman, MD, et al in the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions.



The study was composed of 18 patients who underwent device implantation at three centers in Canada and Switzerland.



Procedural success was achieved in 16 (89%) patients. Unsuccessful procedures were because of right ventricular perforation requiring open surgery and device dislocation. At 1 year there were no deaths, significant arrhythmias, device infections, or dislocations. Thrombus was observed on 1 device at 4 months and there was 1 rehospitalization for heart failure. Among the 14 patients with successful device implantation and 1-year follow-up, 79% were in New York Heart Association functional class I/II (p < 0.001), the average 6-min walk test increased by 84 m (p = 0.03), and the Kansas City Cardiomyopathy Questionnaire heart failure score improved by 18 points (p = 0.02) compared with baseline. Echocardiography showed a reduction of TR from severe in 17 of 18 (94%) patients at baseline to moderate-severe or less in 11 of 16 patients (69%) by 30 days (p = 0.001) and 6 of 13 patients (46%) by 1 year (p = 0.01). The diameters of the tricuspid annulus and the right ventricle were reduced at 1 year (45.7 ± 4.8 mm to 42.1 ± 4.4 mm, p = 0.004; 54 ± 5.3 mm to 49.9 ± 4.3 mm, p = 0.02, respectively).



Implantation of the FORMA system in high-risk patients with severe TR shows feasibility with a good mid-term safety profile. At 1 year, despite variable success in reducing echocardiographic TR grade, there were significant clinical improvements and reductions in right ventricular dimensions.



See more about the FORMA System on Meddevicetracker.



Antares Pharma Announces Sale of ZOMAJET Delivery System


Antares Pharma announced that it has entered into a purchase agreement to sell the worldwide rights, including certain fixed assets, for the ZOMAJET needle-free auto injector device to Ferring Pharmaceuticals for up to $14.5 million. The purchase price will be paid in four installments consisting of a $2.0 million upfront payment, a second installment of $2.75 million payable upon satisfaction of certain conditions, a third installment of $4.75 million payable upon satisfaction of customary closing conditions and the remaining payment of $5.0 million upon the completion of the transaction.



To date, Antares has been the worldwide supplier of ZOMAJET devices to its partners Ferring and JCR Pharmaceutical Company Ltd. and will continue to manufacture and supply the devices until the completion date pursuant to existing supply arrangements. During the completion period, Antares will continue to receive payment for ZOMAJET devices manufactured and supplied to its partners and a royalty on net product sales in accordance with the existing license and supply agreements. The transaction is subject to certain customary closing conditions and expected to be completed by the end of 2018.



ZomaJet is used to deliver Ferring’s Zomacton (somatropin), a treatment indicated for the treatment of Growth Hormone Deficiency (GHD) in children and Turner Syndrome in girls.



See more about the Medi-Jector VISION Device on Meddevicetracker. As this is a drug-device combination product, the full regulatory history and current marketing status of Zomacton can be seen on Biomedtracker.




October 11, 2017

MiMedx Announces Published Results for EpiFix



MiMedx announced that a peer-reviewed clinical study of MiMedx dehydrated human amnion/chorion membrane (dHACM) allografts has been published in the International Wound Journal in an article titled "A Multicenter Randomized Controlled Trial Evaluating the Efficacy of Dehydrated Human Amnion/Chorion Membrane (EpiFix) Allograft for the Treatment of Venous Leg Ulcers."



The study was a 16 week randomized, fifteen-center, clinical trial conducted to evaluate the efficacy of EpiFix as an adjunct to moist wound dressings and multilayer compression bandages for the treatment of non-healing full-thickness VLUs. Subjects (n=109) were randomized to receive EpiFix in addition to moist dressings and compression (n=52) or moist dressings and compression alone (n=57).



The primary endpoint of the study was time to complete wound closure, as assessed over a 12-week period from treatment initiation. Secondary endpoints included the proportion of subjects with complete wound closure by 12 and 16 weeks. Complete healing of the study ulcer was defined as 100% re-epithelialization without drainage.



Within 12 weeks of randomization, 31 of 52 (60%) VLU patients receiving EpiFix completely healed compared with a healing rate of 20 of 57 (35%) in those treated with standard care alone (P=0.0128). At the 16 -week follow-up visit, complete VLU healing was observed in 37 of 52 (71%) and 25 of 57 (44%) of those treated with EpiFix or standard care, respectively (P=0.00625). Mean percentage reduction in wound area within 12 weeks was 66% for EpiFix-treated wounds and 40% for wounds not treated with EpiFix. At week 16, mean VLU area was reduced by 72% for EpiFix-treated wounds compared to 39% with standard care. While adjusting for baseline wound size, investigators saw that the week 12 adjusted mean for EpiFix (2.82 cm2) is significantly lower than the week 12 adjusted mean for standard care (4.81 cm2), with a P-value of 0.0435. Likewise, investigators saw that the week 16 adjusted mean for EpiFix (2.28 cm2) is significantly lower than the week 16 adjusted mean for standard care (4⋅90 cm2), with a P-value of 0.0098.



A Kaplan–Meier plot of time to heal within 12 weeks by study group demonstrated a superior wound-healing trajectory for EpiFix compared to VLUs treated with standard care alone. The log-rank test of equality of the healing function over the two study groups produced a chi-square test statistic of 6.4597, with P=0.011.



In the company's earlier press release from August 2017, MiMedx confirmed the results of the study:

  • Patients treated with EpiFix showed VLU healing rates of 60% within 12 weeks and 71% within 16 weeks. Healing rate in this context means the percentage of patients that achieved complete healing.
  • EpiFix showed clinical superiority over Standard of Care (SOC) in the treatment of non-healing, full thickness VLUs. Wounds treated with EpiFix were 2.26 times more likely to heal within 12 weeks than wounds treated with standard care alone.
  • Results of this study are vastly superior to VLU healing rates reported in studies of other advanced wound care products.
  • In the 1998 randomized study of VLU healing rates with Apligraf conducted by Falanga, et al., a healing rate of 63% was reported at 24 weeks, which, while a separate study, nevertheless corresponds to the week 12 healing rate of 60% with EpiFix reported in this study. The healing results observed with EpiFix within 12 weeks are even more remarkable given that Falanga, et al. reported a mean wound size of 1.33 ± 2.69 cm2 for Apligraf treated subjects, and excluded patients with uncontrolled diabetes and other clinically significant medical conditions that could impair wound healing. In this EpiFix study, patients with these types of comorbidities were included and mean wound size was considerably larger at 7.6 ± 6.1 cm2.



See more about EpiFix on Meddevicetracker.



Neuronetics Receives Japanese Approval for NeuroStar



Neuronetics announced it has received Shonin approval by Japan's Ministry of Health, Labor and Welfare to sell and distribute its NeuroStar Advanced Therapy system in the country. NeuroStar Advanced Therapy is the first transcranial magnetic stimulation to be selected as a safe and effective non-drug treatment option for Major Depressive Disorder (MDD) in Japan.



NeuroStar Advanced Therapy is a non-invasive treatment that uses MRI strength magnetic pulses to stimulate areas of the brain that are underactive in depression. It is not electroconvulsive therapy (ECT) and uses a different mechanism than ECT. Backed with the most clinical studies for TMS in depression, NeuroStar Advanced Therapy is free from side effects often associated with antidepressants.



In addition to its recent expansion into Japan, NeuroStar Advanced Therapy is commercially available in the United States of America as well as the Middle East and Asia regions. NeuroStar Advanced Therapy is also CE marked.



See more about the NeuroStar TMS Therapy System on Meddevicetracker.




October 12, 2017

DePuy Synthes Launches TNFA Augmentation System

DePuy Synthes announced the U.S. launch of the new TFNA Augmentation System, a polymethylmethacrylate (PMMA) cement with specific trauma device indications, offered exclusively for use with the TFNA System. The TFNA Augmentation System is used to address the needs of patients with hip fractures and who have poor bone quality.



The TFNA Augmentation System can be used to provide enhanced implant fixation in cases where the potential risk of cut-out is significant. Cut-out is a loss of implant anchorage or stability in the bone, frequently occurring in those with poor bone quality. It causes the femoral neck-shaft angle to collapse, and is a leading clinical complication during hip fracture surgery. Cut-out can also lead to re-operation, which increases risks to the patient and increases costs to the healthcare system. When used together with the TFNA System, the TFNA Augmentation System is designed to help reduce the risk of cut-out and provide enhanced implant fixation.



The system received 510(k) clearance in September 2016.



See more about the TFN-Advanced Proximal Femoral Nailing System on Meddevicetracker.



Boston Scientific and Mayo Clinic File Joint Patent Application


Boston Scientific and the Mayo Clinic recently filed a joint patent application for a new self-centering catheter device as a result of a collaborative development deal the two announced in March 2016.



The new device is being designed to help improve heart valve replacement surgery by improving the process of threading guide wires through shrunken and often times shifted aortic valve openings in calcified hearts, according to the report. Currently, surgeons must probe along the surface of the valve with the guide wire to find the opening, requiring constant X-ray imaging and anesthesia and risking possible damage to the valve and arteries through the dislodgment of calcified debris. The jointly developed catheter is designed to center over the opening prior to advancing and includes a covered basket created to self-center over the opening by aligning with the direction of blood flow.



Other collaborative projects between the two include using Boston Scientific’s Precision Spectra spinal cord stimulator to block neural signals that cause shortness of breath and muscle fatigue in heart failure patients. A study of the device aims to explore the efficacy of blocking signals from organs to the brain and whether or not it can help improve control of the heart and vasculature for those patients. Both parties announced the program last March, revealing approximately a dozen new products in the pipeline, including the centering catheter for replacement heart valves and the heart failure application for the Precision Spectra SCS.



See more about the Heart Valve Surgery Self-Centering Catheter on Meddevicetracker.




October 13, 2017

Endonovo Completes Preclinical Study Using Immunotronics

Endonovo announced that it has completed a study to evaluate the potential efficacy of its Immunotronics platform, a non-invasive electroceutical, in a well-established preclinical model of heart failure (post-MI remodeling).



The recently completed study investigated the therapeutic efficacy of the Company's Immunotronics platform in a widely used mouse model of heart failure (post-MI remodeling).



In this model, treatment with the Company's non-invasive electroceutical two or three times per day resulted in significantly increased cardiac function and reduced ventricular remodeling. Treatment with the Company's Immunotronics technology two or three times per day resulted in significantly improved Ejection Fraction (EF), Fractional Shortening (FS), Heart Weight-to-Body Weight Ratio (HW/BW), Left Ventricular Diastolic Pressure (LVDP), Left Ventricular End-Systolic Diameter (LVESD), and Interventricular Septal Dimension at Systole (IVSS).



The Company plans to submit its preclinical post-MI remodeling results during 2018 for presentation at a relevant scientific meeting.



See more about Immunotronics on Meddevicetracker. 

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