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Shockwave Medical Appoints new CFO
Shockwave Medical, Inc., a trailblazer in advancing and bringing to market groundbreaking technologies for treating cardiovascular ailments, has announced the appointment of Renee Gaeta as its new Chief Financial Officer (CFO), effective February 5, 2024. Renee takes over from Dan Puckett, who has served as Shockwave's CFO since 2016 and has announced his retirement. “Renee is a highly skilled and accomplished executive with a proven track record in the medical device and healthcare industries,” said Doug Godshall, Chief Executive Officer at Shockwave. “I am thrilled to welcome Renee to Shockwave and look forward to partnering with her through our next phase of growth and profitability. I would also like to thank Dan Puckett for his exemplary leadership and outsized contribution to the success of Shockwave. Though Dan will be missed, fortunately he will continue to work with us in a consulting capacity.” Renee Gaeta most recently held the position of CFO at Eko Health, overseeing both finance and human resources as the company expanded its digital cardiopulmonary care platform. She has also been a board member and part of the audit committee at Candel Therapeutics since August 2022. Prior to her role at Eko Health, Renee served as CFO and a member of the executive team at Establishment Labs Holdings, Inc., contributing significantly to the company's successful initial public offering and global business growth. Renee earned her Bachelor of Science degree in accounting with honors from Loyola Marymount University and holds a Certified Public Accountant license in the State of California. “Shockwave is one of the most exciting and innovative companies in the medical technology industry and it is an honor to be joining the company at such a pivotal time in its growth,” said Renee. “The progress Shockwave has made in establishing IVL as a standard of care while also strategically expanding the business to help patients is inspiring. I am thrilled to be part of the team and the mission to transform treatment paradigms for poorly served patient populations with breakthrough technologies.”
Boston Scientific reports favorable data on spinal cord stimulation
Boston Scientific has unveiled positive outcomes after one year from a trial assessing its spinal cord stimulation (SCS) technology. The SOLIS randomized control trial demonstrated enduring pain relief through the WaveWriter Alpha SCS system for the treatment of non-surgical back pain (NSBP). Boston Scientific disclosed the findings at the 2024 North American Neuromodulation Society (NANS) meeting held in Las Vegas. Dr. James North presented the SOLIS findings, encompassing 128 randomized subjects. At the primary endpoint interval, 90% of patients treated with WaveWriter reported significant pain relief of 50% or more without an increase in opioid usage. In contrast, only 8% of patients treated solely with conventional medical management reported a similar level of relief. After one year, 84% of patients treated with WaveWriter reported 50% or more pain relief and sustained enhancement in the ability to engage in daily activities. Boston Scientific noted a 25-point improvement in disability as measured by the Oswestry Disability Index (ODI). Patients undergoing conventional medical management who later opted for SCS therapy experienced noteworthy improvements in pain and disability at the one-year mark. According to a press release, these outcomes remained comparable to subjects in the SCS arm, with 85% of crossover subjects reporting a 50% or greater reduction in pain and a mean 30-point improvement in ODI. “Continued positive results from the SOLIS study illustrate the need for early and effective pain treatment when just the standard of care is not enough,” said Jim Cassidy, president, Neuromodulation, Boston Scientific. “Backed by consistently strong clinical evidence, our transformative pain management solutions help individualize care and improve the quality of life for the many people living with chronic pain today.” The company also shared real-world results from 43 patients utilizing spinal cord stimulation (SCS) for painful diabetic peripheral neuropathy (DPN). The data indicated a substantial decrease in pain and noteworthy rates of patient improvement across all long-term assessments for SCS users. In the two-year follow-up, 81% of patients reported experiencing a 50% or more reduction in pain. Over a period of up to three years, they consistently reported a high level of improvement and satisfaction with the treatment. Boston Scientific additionally presented clinical outcomes involving fast-acting sub-perception-based therapy (FAST therapy). Various prospective and real-world studies demonstrated significant and enduring pain relief through the company's exclusive FAST therapy. FAST therapy was specifically designed to offer immediate, paresthesia-free relief from pain. At around the one-year follow-up mark, the studies observed consistent improvement. A minimum of 88% of SCS patients reported a 50% or more reduction in pain. The assessment of the 311 enrolled patients is still ongoing.
Successful completion of the inaugural shoulder arthroplasty surgeries utilizing…
Stryker, one of the world’s leading medical technology companies, has announced the successful completion of the initial shoulder arthroplasty surgeries using Blueprint® Mixed Reality (MR) Guidance. The procedures were conducted by Dr. Joaquin Sanchez-Sotelo, MD, PhD, a Consultant and Professor of Orthopedic Surgery at Mayo Clinic in Rochester, Minn., and Dr. George Athwal at St. Joseph’s Health Care in London, Canada. “Mixed reality technology offers important benefits to patients,” said Dr. Sanchez-Sotelo, one of the Blueprint design surgeons. “This technology allows the surgeon to plan and execute the surgery based on precise images of the patient’s shoulder, thereby minimizing the risk of improper placement of the implant. This is individualized care tailored to each patient’s anatomy.” Developed by a team of renowned surgeons, the Blueprint MR Guidance System integrates Stryker's advanced software with the Microsoft HoloLens™ 2* headset. This system enables surgeons to monitor the position and orientation of surgical instruments within the physical environment. Through Blueprint MR Guidance, surgeons can be 'guided' by 3D images and guidance widgets, displayed on the patient and in the surgeon’s line of sight without disrupting the normal workflow. The MR Guidance system received FDA clearance in January 2023. “The addition of Mixed Reality Guidance to our Blueprint platform has the potential to benefit the entire shoulder arthroplasty market – surgeons and patients alike,” said Tim Lanier, president of Stryker’s Trauma & Extremities division. “Now that Mixed Reality Guidance has officially entered the operating room, our surgeons will have access to the most innovative technology available, enabling more precise surgical results and allowing for improved results for patients.” Previously known as Blueprint Mixed Reality OR Visualization, the earlier version of Stryker’s Blueprint Mixed Reality has been utilized by over 50 surgeons and employed in more than 3,500 shoulder replacement procedures globally. For further information about Blueprint and Mixed Reality, you can visit shoulderblueprint.com. Stryker envisions the completion of the first case employing the Blueprint® Mixed Reality (MR) Guidance System in Europe in February, representing a noteworthy milestone in the advancement of global surgical technology.
Medtronic obtains CE mark for the MiniMed system with…
The MiniMed 780G system with Simplera Sync sensor will be available in Europe via limited release in spring 2024. Medtronic will begin the phased commercial launch in Europe in the summer of 2024. Today, the MiniMed 780G system can be used with the Guardian 4 sensor. The MiniMed 780G system is Medtronic's most advanced insulin delivery system, automatically adjusting and correcting glucose levels every five minutes. It's the world's only system with a Meal Detection feature that is designed to reduce post-meal hyperglycaemia when users occasionally forget to give themselves insulin or underestimate the number of carbs in their snacks or meal. The system, which is available with the world's only 7-day infusion set, also features one of the lowest glucose target settings (as low as 100 mg/dL) of any automated insulin delivery system. With this "treat to target" approach, the system more closely mirrors the glucose levels of someone not living with diabetes. With both Simplera Sync sensor and the Guardian 4 sensor, no fingersticks are required. Robert Vigersky, M.D., chief medical officer, Medtronic Diabetes, professor of medicine, Uniformed Services University of the Health Sciences, said: "A challenging aspect of living with diabetes is counting carbohydrates and dosing the right amount of insulin before consuming snacks and meals. Many people underestimate their carbs, which can lead to high blood sugars (hyperglycaemia). Prolonged hyperglycaemia can lead to serious health problems impacting the eyes, major organs, and even cognitive function, which is particularly concerning in developing children. With its responsive algorithm, the MiniMed 780G system can help people living with diabetes even when they occasionally forget to bolus or undercount their carbs. The system takes on more of the work involved in diabetes management and helps alleviate mental burden." Que Dallara, EVP and president, Medtronic Diabetes, added: "We're incredibly proud that the MiniMed 780G system continues to be the most widely used automated insulin delivery system in Europe since we launched it in 2020. Real-world data on over 100,000 users on the system across many geographies and cultures shows that when using recommended settings, the system is delivering an average Time in Range of nearly 80%, raising the bar on what 'good' looks like. With the introduction of Simplera Sync sensor, we're able to offer the proven benefits of our MiniMed 780G system with our newest and most comfortable sensor that can be applied in under 10 seconds." The MiniMed 780G system with Simplera Sync sensor is indicated for ages 7+ and compatible with iOS and Android. Simplera Sync sensor is not approved by the FDA and is limited to investigational use in the U.S.

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