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Medical Device News Magazine reports breaking news including clinical trial updates, product launches, profiles of device companies, acquisitions, executives on the move, non-profit and medical society news and more. Read with great interest by practicing medical specialists, industry executives, investors and other allied health professional. We invite you to visit our magazine daily!

BREAKING MEDICAL DEVICE NEWS

Companies Who Made the Cut!

Regentis Expands SAGE Clinical Trial Study of GelrinC for Damaged Articular Cartilage

REGENTIS BIOMATERIALS2018-10-23

Regentis Biomaterials today announced it has expanded the SAGE clinical trial of GelrinC™ for the treatment of articular cartilage damage in the knee to...

Valiant Navion™ Thoracic Stent Graft System Receives FDA Approval

Medtronic2018-10-23

10/23/18: Until now, patients with small iliac arteries were considered ineligible for thoracic endovascular aneurysm repair (TEVAR) or required adjunctive procedures to accommodate calcification and tortuosity concerns. Valiant Navion allows for the potential for more patients to receive a percutaneous procedure and overcome these anatomical concerns, enabling a less invasive approach to treatment compared to surgical cut-down (open) procedures.

Aortica™ Corp. Announces Publication of Successful Results Demonstrating Simplification of Fenestrated EVAR Using AortaFit™ Automated Case Planning Software

Aortica Corp2018-10-22

10/22/18: The study is an FDA approved physician-sponsored investigational device exemption (IDE) study, administered in conjunction with Harborview Medical Center and run by Dr. Benjamin Starnes, Chief of Vascular Surgery at the University of Washington (UW). Endovascular Aneurysm Repair (EVAR) is the gold standard for treatment of Abdominal Aortic Aneurysms (AAA).

Levita® Magnetics Announces FDA Clearance of Expanded Indication for Magnetic Surgical System for Use in Bariatric Procedures

Levita® Magnetics2018-10-22

10/22/18: Initially indicated for use in gallbladder removal procedures, the shaftless Magnetic Surgical System reduces the number of incisions necessary for the indicated procedures.

New Study Details Radiation Therapy Treatment Planning Method for AeroForm® Patients

AirXpanders, Inc.2018-10-22

10/22/18: "The primary aim of this study was to examine the effects of radiation treatment on AeroForm Tissue Expanders and to describe the planning protocol for these patients. Our findings revealed that it is feasible to plan with a conventional 3D planning technique that is reproducible and the early outcomes of AeroForm patients treated with external beam radiation therapy are similar to patients without AeroForm Tissue Expanders," said Dr. Yvonne Zissiadis, Genesiscare, Lead Investigator of the study.

Fuji Film Announces Entry into the U.S. Computed Tomography Marketing with Unveiling of FCT Embrace at ASTRO 2018

Fujifilm2018-10-22

10/22/18: Powered by Analogic, the FCT Embrace is the world’s first 85cm wide bore computed tomography (CT) imaging unitwith 64 or 128 slice configurations.

Ocular Therapeutix™ Reports FDA Warning Letter Related to ReSure® Sealant

Ocular Therapeutix, Inc.2018-10-19

10/19/18: The letter relates to Ocular’s compliance with data collection and information reporting obligations in a post-approval Device Exposure Registry study required as a condition for approval of the premarket approval (PMA) application for ReSure® Sealant.

Canon Medical Showcases FDA-Cleared Aquilion Precision at ASTRO 2018

Canon Medical Systems USA2018-10-19

10/19/18: “The Aquilion Precision sets a new bar for CT imaging,” said Dominic Smith, senior director, CT, PET/CT, and MR Business Units, Canon Medical Systems USA. “With the highest level of resolution available in the CT market, our customers have the ability to better visualize disease, which can potentially help clinicians in treatment planning.”

Abbott’s HeartMate 3 Heart Pump Now FDA Approved for Advanced Heart Failure Patients Not Eligible for a Heart Transplant

Abbott2018-10-19

10/19/18: With the approval, physicians can now offer the HeartMate 3 system to patients not eligible for a transplant who will live with their device for the rest of their lives.

New Study: Abbott’s Novel Diagnostic Test Has the Potential to Demonstrate Gold Standard Accuracy and Speed

Uncategorized2018-10-17

10/17/18: New data, published online in JAMA Cardiology, found a new blood test under development that is done right at the patient's side in as little as 15 minutes could identify nearly three-fifths (56.7 percent) of people at low-risk of experiencing a heart attack, similar to the results of a High Sensitive Troponin-I blood test done in the laboratory setting.

Restoration Robotics® Announces Results of Real-World Case Study for ARTAS iX™ System

Restoration Robotics2018-10-17

10/17/18: The results are from a real-world case study conducted by David A. Berman, M.D., FAAD, a leading hair restoration surgeon, founder of the Berman Skin Institute in California and one of the first users of the ARTAS iX System, and he developed a poster entitled “Robotic, AI-assisted Follicular Unit Excision And Implantation For Hair Restoration With ARTAS iX” during the American Society for Dermatologic Surgery (ASDS) Annual Meeting 2018.

Enrollment in U.S. Pilot Study Evaluating Bioelectronic Device for Treatment of Rheumatoid Arthritis Completed

SetPoint Medical2018-10-17

10/17/18: The primary purpose of this multi-center, randomized study is to evaluate safety and tolerability of SetPoint’s proprietary device, which is surgically placed on the vagus nerve. The study includes 14 subjects who had failed or were intolerant to multiple, mechanistically different, biologic therapies. Initial feedback from neurosurgeons performing the implantation has been positive. The company anticipates data readout in the first quarter of 2019.

LINX Reflux Management System Significantly More Effective than Standard of Care Medical Therapy in Treating GERD Symptoms

ETHICON2018-10-17

10/17/18: The CALIBER study, the first randomized controlled clinical trial to compare the anti-reflux procedure to proton pump inhibitors (PPIs), the standard of medical care for GERD treatment, was published in GIE: Gastrointestinal Endoscopy, the peer-reviewed journal of the American Society for Gastrointestinal Endoscopy (ASGE).

Ackerman Cancer Center Celebrates 1,000 Patients Treated with Proton Therapy

Mevion Medical Systems®2018-10-16

10/16/18: “One of the core values of Ackerman Cancer Center is to ensure patients have access to the most effective and innovative cancer therapies available. Through the use of Proton Therapy, our physicians have witnessed better tolerance in patient treatments, excellent overall outcomes and healthier patients post treatment,” said Scot Ackerman, MD, Medical Director of Ackerman Cancer Center.

Peer-Reviewed Article on Tiara™ Cases in Journal

Neovasc Inc2018-10-16

10/16/18: The article describes the periprocedural and short-term outcomes of patients with severe MR and previous surgical aortic valve prosthesis replacement treated with the Tiara. The article describes procedural success rate of 100% with no death, myocardial infarction, stroke, major bleeding, or access site complications at 30 days.

Medtronic Launches the Control Workflow(SM) to Help Eliminate Oral Opioids and Provide Effective Pain Relief

Medtronic2018-10-16

10/16/18: "The Control Workflow assists me in identifying appropriate patients who could benefit from targeted drug delivery using the Medtronic pain pump, which is especially important with the current opioid epidemic in the United States," said John A. Hatheway, M.D., owner and provider, Northwest Pain Care, Spokane, Wash.

Solstice SRS Immobilization System Receives FDA 510k Clearance and CE Mark

Uncategorized2018-10-15

10/15/18: The product will be available for shipment following its display at the American Society for Radiation Oncology (ASTRO) Meeting taking place October 21-24, 2018 in San Antonio, Texas.

Enrollment Completed Of International Post-Market SAVE Registry With Early Positive Results

Bluegrass Vascular Technologies2018-10-15

10/15/18: In addition, the company also announced expanded patient enrollment and study sites in the SAVE-US (Surfacer System to Facilitate Access in VEnous Occlusions – United States), a pre-market investigational device exempt study.

Market Reports

Cardiac Biomarker Diagnostic Test Kits Market Would Reach US$ 2,540.8 Mn by 2028

Market Analysis 2018-10-16

10/16/18: the global cardiac biomarker diagnostic test kits market is projected to expand at a CAGR of 5.1% during the forecast period 2018-2028 and reach US$ 2,540.8 Mn by the end of 2028.

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Urolithiasis Management Devices Market to Earn US$1.78 Billion by 2024 With Rising Number of Geriatric Population

Market Analysis 2018-10-05

10/5/18: As per the TMR report, the global urolithiasis management devices market is estimated to earn US$1.78 bn by the end of 2024. The market is presumed to expand to 4.5% CAGR within the forecast period of 2016 to 2024.

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Global Left Ventricular Assist Device Market Outlook to 2023

Market Analysis 2018-10-05

10/5/18: The Global Left Ventricular Assist Device Market was worth 1024 Million USD in 2017 and it is estimated to grow to 1860 Million USD by 2023 with a CAGR of 10.46% between 2017 and 202

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Global In Vitro Toxicology Testing Market 2018-2024 by Toxicology Endpoints, Industry Type, and Regions

Market Analysis 2018-10-05

10/5/18: The global in vitro toxicology testing market is estimated to witness a CAGR of 8.2% during the forecast period 2018-2024.

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The Infusion Therapy Devices Market in India 2018-2024

Market Analysis 2018-09-25

9/25/18: The current lack of medical personnel is one of the major obstacles to the growth of the infusion therapy device market in India.

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Surgical Sutures Market to Gain Revenue Worth US$ 5080.1 Mn by 2025

Market Analysis 2018-09-20

9/20/18: Rising demand for carrying out surgical activities owing to an increase in healthcare issues as well as external situations such as accidents is primarily driving the global surgical sutures market. With increasing geriatric population, a surge in serious healthcare ailments have reportedly occurred, many of which might need surgical treatments.

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Kidney Stone Management Devices Market to Reach US$ 1,500 Million by 2028

Market Analysis 2018-09-20

9/20/18: Rising preferences for minimally-invasive and non-invasive surgical procedures continues to be a massive trend in the kidney stone management devices market. Growing incidence rate of kidney stones, combined with the availability of affordable minimally invasive treatment is likely to sustain demand for kidney stone management devices during the forecast period 2018-2028. The report opines that manufacturers will be hard-pressed to develop innovative devices for large stones, as it has remained a longstanding challenge for healthcare providers.

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Executives on the Move

Bovie Medical Corporation Announces Appointment of Laura Iversen as Director of Global Operations for Advanced Energy

Executives2018-10-22

10/22/18: Laura Iversen will be responsible for all aspects pertaining to the operations and manufacturing of our Advanced Energy portfolio.

Michael Mrochen PhD and Vivior Chairman Received the Casebeer Award from the International Society of Refractive Surgery

Executives2018-10-22

10/22/18: Michael Mrochen is internationally known for his pioneering work on corneal laser surgery, corneal cross linking, ocular biometry and cornea inlays for presbyopia and hyperopia.

Financial Healthcare Conferences

Sonendo® Invited to Present at Prestigious Red Herring Global 100 Event

Healthcare Conferences2018-10-22

10/22/18: President and CEO, Bjarne Bergheim had this to say about the event, "Sonendo was honored to win the Red Herring Top 100 Global in 2017, and since then we have experienced exponential growth due to market demand for the GentleWave Procedure. I look forward to presenting at this year's event and sharing the continuation of our remarkable journey."

Aethlon Medical to Present at the 2018 BIO Investor Forum

Healthcare Conferences2018-10-16

10/16/18: Aethlon Medical is focused on addressing unmet needs in global health. The Aethlon Hemopurifier® is clinical-stage immunotherapeutic device candidate to combat cancer and life-threatening viral infections. The Hemopurifier® has been designation a "Breakthrough Device" by United States Food and Drug Administration (FDA) related to the treatment of life-threatening viruses that are not addressed with approved therapies.

Non-Profit

Hospital for Special Surgery Receives Landmark $10 Million Grant from Stavros Niarchos Foundation for Complex Joint Reconstruction Center

NON PROFIT2018-10-16

10/16/18: "This generous gift will improve the lives of countless patients who suffer from debilitating complications or need revision surgery due to failed implants," said Thomas P. Sculco, MD, surgeon-in-chief emeritus and director of the CJRC at HSS. "We are deeply honored by the visionary leadership of the SNF in supporting our endeavor to lessen implant failure, restore function, and relieve pain for patients who need specialized joint reconstructions."

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