LivaNova Secures FDA Approval for Clinical Study to Assess the aura6000 System for Obstructive Sleep Apnea Treatment
On June 15, 2021, LivaNova PLC received approval from the US Food and Drug Administration (FDA) to continue with its investigational device exemption (IDE) clinical study, “Treating Obstructive Sleep Apnea using Targeted Hypoglossal Neurostimulation (OSPREY).” The OSPREY study will attempt to demonstrate the safety and effectiveness of the aura6000® System, the LivaNova implantable hypoglossal neurostimulator for treating adult patients with moderate to severe obstructive sleep apnea (OSA).
The aura6000 System is an innovative alternative to the traditional continuous positive airway pressure (CPAP) machine, generating stimulation via a programmable, rechargeable, and implantable pulse generator (IPG). The IPG is implanted in a subcutaneous pocket near the patient’s clavicle via an outpatient surgery and delivers mild stimulation pulses. This leads to the hypoglossal nerve spurring the tongue during sleep and keeping the patient’s airway open.
The company will launch the OSPREY clinical study to demonstrate the safety and effectiveness of the aura6000, which received a CE mark in 2012. This randomized controlled trial (RCT) will occur at around 20 sites across the United States and enroll a maximum of 150 adult patients with moderate to severe OSA who do not get results from a traditional CPAP machine or have refused its use.
Olympus Corporation of the Americas Announces Market Launch of Telegraph Evolution for Humeral Fracture Treatment
On June 17, 2021, FH ORTHO, a recently acquired company by the Olympus Corporation of the Americas, launched its 510(k)-cleared Telegraph Evolution® surgical nail system, a next-generation humeral nailing system for utilization in proximal and/or mid-shaft humeral fractures. It is designed to promote improved alignment during fracture repair.
It is estimated that the humeral fracture market is at approximately 28,000 procedures/year.
Jean-Marc Idier, President of FH Ortho Inc., said in a statement that the Telegraph Evolution instrumentation and implants proffer a unique, innovative, and less invasive system for surgeons. FH Ortho has been on-trend with developing a system depending on nailing instead of plating for trauma applications. The market has moved towards a fracture alignment strategy zeroed in on the use of nails instead of plates, and a rising number of physicians are praising the move.
NeuraLace Declares FDA 510(k) Clearance and U.S. Launch of Axon Therapy® Peripheral Nerve Stimulation System for Chronic Pain Relief
On June 17, 2021, NeuraLace Medical, Inc. has received FDA 510(k) clearance for Axon Therapy® to stimulate peripheral nerves and provide chronic nerve pain relief non-invasively. The Axon Therapy coil, connected to a compact stimulation module, generates intense magnetic pulses near the injured nerve during the treatment.
Shiv Shukla, Founder, and CEO of NeuraLace Medical, said that after 10 years of R&D, they are pleased to have secured FDA 510(k) clearance for Axon Therapy and they are incredibly exhilarated to bring to market a non-opioid treatment option that offers meaningful relief for patients suffering from chronic pain. They believe Axon Therapy is a significant step forward on the care continuum available to patients. They look forward to bringing sustainable pain relief to patients by launching Axon Therapy in the United States.
Ethicon Expands Advanced Biopolar Energy Portfolio with Launch of ENSEAL X1 Curved Jaw Tissue Sealer
On June 21, 2021, Ethicon, part of the Johnson & Johnson Medical Devices Companies, has launched the ENSEAL X1 Curved Jaw Tissue Sealer, a new advanced bipolar energy device that raises procedural efficiency and provided more robust sealing and better access to more tissue than LigaSure™ Maryland. The device is utilized for the treatment of colorectal, gynecological, bariatric surgery, and thoracic procedures.
It is the first of several new advanced laparoscopic bipolar devices that the company plans to launch in the coming months, expanding its extensive energy portfolio, including market-leading HARMONIC ultrasonic devices and MEGADYNE core electrosurgical tools.
Kate Masschelein, President, Ethicon, said that Ethicon is the only company with the expertise profound and the energy portfolio broad enough to proffer tailored, proven, and reliable product and service solutions, which span virtually every energy modality, surgical specialty, and procedure. They will continue to create innovative solutions that leverage the decades of experience in surgery and the thorough understanding of the science of tissue management, device-tissue interaction, and OR safety to set new standards of performance in surgery.
Medtronic InPen™ Real-World Data and Expanded Infusion Set Pivotal Trial Results Exhibit Potential Clinical Outcomes and Positive User Experience
On June 28, 2021, Medtronic plc announced vital clinical data from the virtual 81st annual American Diabetes Association Scientific Sessions and illustrated an increase in Time in Range when using an InPen™ smart insulin pen, the safety of an extended-wear infusion set that lasts up to 7 days, and patient satisfaction with the longer-wear infusion set.
The company also displayed the US pivotal trial data on the Medtronic Extended infusion set, the first and only infusion set, which can be worn for up to seven days. The study assessed the safety and performance of 259 individuals aged 18 to 80 who wore traditional 2- or 3-day infusion sets with the MiniMed™ 670G system for two weeks followed by twelve consecutive wears of the Medtronic Extended infusion set.
Bruce Buckingham, M.D., emeritus professor of pediatrics and endocrinology at Stanford, said that for decades, insulin infusion sets required to be changed every two to three days. So, the development of an extended infusion set that can be worn for up to seven days demonstrates a tremendous improvement in the patient experience. The pivotal trial showed the safety of the new infusion set and increased satisfaction from being able to wear it longer duration. Reducing the burden of changing infusion sets every two to three days is a very valid improvement in the overall pump experience. This vital innovation in the infusion set will make insulin pump therapy feel easier for many patients.
AngelMed Declares FDA Approval of the Enhanced Real-Time Cardiac Monitor for Acute Coronary Syndrome (ACS) Events
On June 28, 2021, Angel Medical Systems, Inc. received the FDA approval for the second-generation AngelMed Guardian® device. The AngelMed Guardian System is the world’s first implantable cardiac detection monitor and patient-warning system for acute coronary syndrome (ACS) events, including silent heart attacks.
The latest, second-generation device is improved with ease-of-use adaptations and an updated, long-life battery that could double the life of the implanted device. The device is implanted subcutaneously by a cardiologist during a low-risk, outpatient surgical procedure. It continuously records the heart’s electrical activity 24 hours a day, monitoring electrical changes that can indicate an upcoming ACS event.
AngelMed Chief Executive Officer Brad Snow said that the enhanced AngelMed Guardian device would potentially affect the existing standard of patient cardiology care for ACS events. The dedicated team and supporting physicians have worked strenuously to bring this disruptive technology to market. As the first real-time detection device for high-risk heart attack patients, the AngelMed Guardian System offers critical data at the point of care, along with the peace of mind for physicians and patients alike.
CardioFocus Receives Regulatory Approval to Market HeartLight X3 System in Japan
On June 23, 2021, CardioFocus, Inc. has received approval for the company’s HeartLight X3 System for marketing in Japan from the Japanese Ministry of Health, Labor, and Welfare (MHLW). The HeartLight X3 System is CardioFocus’ catheter ablation technology for controlled and consistent pulmonary vein isolation (PVI), the standard gold treatment for AFib.
The company is currently working with Japan Lifeline Co., Ltd. (JLL), its exclusive distribution partner for Japan, to finalize reimbursement pricing, expected to be completed in August. After the finalization of reimbursement, JLL will begin offering HeartLight X3 to patients and providers in Japan.
In 2018, JLL introduced CardioFocus’ first-generation HeartLight in Japan. The technology is the world’s first ablation system that incorporates laser energy and an endoscope for the ablation treatment of AFib (PVI).
Fujifilm Introduces System Integration Platform Especially Designed for Endoscopy Suites
On June 22, 2021, FUJIFILM Medical Systems U.S.A., Inc. launched the industry’s first Systems Integration platform explicitly designed to improve image and data integration in endoscopy suites. It is a specially designed hardware and software configuration that enables the multi-video and image routing and display capabilities that gastrointestinal (GI) physicians need while performing advanced procedures.
Devon Bream, MPH, FACHE, Global Vice President Endoscopy, General Manager Systems Integration, FUJIFILM Medical Systems U.S.A., Inc., said that they comprehend that as innovators in endoscopic imaging, they comprehend that endoscopists need more video sources and more advanced image routing and display when performing intraoperative and therapeutic procedures. Our integration platform was created for this level of image routing and show complexity in the OR. They found that endoscopists would take advantage of leveraging their leading integration capabilities in their endoscopy suites, and they are thrilled to present this solution.
This platform has been installed at Brigham and Women’s Hospital. Clinicians are currently leveraging it and the rest of Fujifilm’s endoscopic imaging portfolio, which was purchased and installed earlier this year.
A World-First Predictive Test for Diabetic Kidney Disease Could Save USD 384 billion over 10 years
On June 25, 2021, Proteomics International Laboratories Ltd announced that testing for diabetic kidney disease with the PromarkerD prognostic blood test could reserve US payers almost USD 400 billion over 10 years, as per a research study. The ground-breaking PromarkerD test is the only available test capable of speculating the onset of diabetic kidney disease in patients with type 2 diabetes.
Currently, 31 million adults with diabetes in the US require the simple test, set at USD 150 for an annual testing regime, and would cost USD 8.9 billion annually; however, it could produce USD 473 billion over ten years.
Proteomics International managing director Dr. Richard Lipscombe told the research extends the initial modeling to accentuate the benefits of an early, accurate, and cost-effective prognosis. He said that testing patients with type 2 diabetes every 6-12 months with PromarkerD would allow early intervention for those at high risk of developing diabetic kidney disease.
Pulnovo Medical: A Pulmonary Arterial Hypertension Medical Device Company Finished the World’s First Pulmonary Hypertension Treatment Device RCT Study after Gaining FDA Breakthrough Designation
On June 28, 2021, Pulnovo Medical’s PADN-CFDA clinical trial, the world’s first pulmonary hypertension treatment device RCT study, completed all patients enrolment and will continue to assist each enrolment center in completing the follow-up of enrolled patients, data recovery, data cleaning, and others, and cooperate with the nation’s research center to finish follow-up work.
The PADN device is intended for pulmonary hypertension and can be used to combine percutaneous pulmonary artery denervation to treat pulmonary hypertension patients. The self-developed radiofrequency ablation product gained the US FDA Breakthrough designation in 2021.