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Stryker Unveils its Next-Generation of Advanced Surgical Cameras
Stryker, a prominent global medical technology firm, has introduced the latest generation of minimally invasive surgical cameras, known as the 1788 platform, today. This advanced camera system is poised to revolutionize surgery across various medical specialties. The all-in-one surgical camera platform delivers enhanced image quality with well-balanced lighting, a broader spectrum of colors, and sharper fluorescence signal delineation. This platform has been meticulously designed to offer improved visualization of blood circulation and vital anatomical structures. It possesses the capability to visualize multiple optical imaging agents at critical moments during surgical procedures. "When it comes to surgical outcomes, dependable imaging is one of the most critical factors. With the enhanced imaging capabilities of the 1788, surgeons have a complete surgical camera technology that provides consistent and vivid imaging," said Dr. Matthew Albert, colon and rectal surgeon at Advent Health. "Patients deserve high-quality care, and we're thrilled that this solution allows our operating room teams to deliver just that." Importantly, the 1788 platform is compatible with existing imaging agents currently available in the market and can be adapted to accommodate new agents and fluorescence modes as they emerge. These technological advancements expand the range of clinical applications and benefit various medical specialties, including urology, neurology, as well as ear, nose, and throat procedures. "Stryker partnered with our surgeon users to design the 1788 platform to be a powerful partner in the OR and to enhance the surgical experience across specialties. This is another way in which Stryker is living up to its rich legacy of delivering the most innovative surgical technology to help surgeons support improved patient outcomes," said Andrés Rosales, vice president and general manager of Stryker's Endoscopy business unit. "The early feedback has been that the 1788 camera delivers better fluorescence imaging and an enhanced user experience, which is particularly helpful in those deep or highly complex cases when surgeons are working in tight cavities—such as sinus cases and pituitary resections," added Rosales. "Clear visualization is a necessity when a patient's life is in your hands. It's important that surgeons can visualize perfusion and critical anatomy to make surgical decisions intraoperatively," said Dr. Albert. Key features of the 1788 platform include: A wider color gamut, offering 62.5 times more visible colors. Enhanced fluorescence imaging with improved consistency. High dynamic range and a new tone mode for more even lighting. Clearance for visualizing CYTALUX®, an imaging agent designed to illuminate lung and ovarian cancer during surgery.
Boston Scientific receives FDA approval for latest generation Watchman…
Boston Scientific has gained approval from the U.S. Food and Drug Administration for the latest iteration of their Watchman FLX Pro Left Atrial Appendage Closure (LAAC) device. This advanced device is designed to enhance the procedural safety and effectiveness of the Watchman technology, specifically for patients with non-valvular atrial fibrillation (NVAF) who require an alternative to oral anticoagulation therapy to reduce the risk of stroke. The latest version of the device incorporates a polymer coating, visual markers, and an expanded size range, enabling treatment for a broader spectrum of patients. The Watchman FLX Pro builds upon the proven safety and performance of its predecessor, the Watchman FLX LAAC device, which received approval in July 2020 and has been used in nearly 190,000 out of the over 300,000 successful Watchman procedures conducted worldwide to date. The latest iteration of the Watchman FLX Pro features a coating designed to reduce device-related clot formation and promote quicker, controlled healing and tissue coverage on the device's surface. Additionally, new visual markers have been added to facilitate precise device placement for effective sealing around the left atrial appendage (LAA). This new version also introduces a 40mm size option, enabling physicians to treat a wider range of anatomies with the Watchman technology. Joe Fitzgerald, group president, cardiology, Boston Scientific, said: "We are pleased to introduce U.S. clinicians to our newest LAAC technology, which is designed to enhance post-procedural healing, improve the precision of Watchman FLX Pro implants, and expand the size range of treatable appendages. These enhancements to our Watchman FLX technology will enable efficiency during implant procedures and allow physicians to optimise treatment for their patients." Preclinical research on this new technology has yielded promising results, including faster, more controlled healing around the device surface. Data from several preclinical studies show an 86% reduction in inflammation three days post-procedure, a 70% reduction in clot formation at 14 days, and a 50% increase in tissue coverage of the device's surface at 45 days post-procedure. Dr. Kenneth Stein, senior vice president and global chief medical officer, Boston Scientific, said: "There is a rich history of safe use and low thrombosis rates in cardiovascular devices that utilise this thromboresistant polymer coating, and we have adapted that model to provide a more streamlined healing process that begins immediately following LAAC. We believe this evolution of the Watchman device also gives promise for a future with less thrombosis risk, which may eventually enable a simpler post-implant drug regimen for patients." The Watchman FLX Pro device retains key features of the Watchman FLX, such as its fully rounded design for safe access and maneuverability within the left atrial appendage. It can also be fully retrieved, repositioned, and re-deployed for precise placement. Its frame design ensures optimal device engagement with tissue for long-term stability and a faster, more complete seal. The Watchman FLX Pro device is currently under investigation in the Watchman FLX Pro CT study, a pre-market study conducted at a single center using various imaging techniques to evaluate post-procedural tissue coverage of the device and its potential impact on clinical outcomes. Additionally, it will undergo further assessment in the post-market HEAL-LAA study, commencing in the coming weeks, which will monitor outcomes in around 1,000 NVAF patients who have received the technology at 60 sites across the U.S.
Edwards Lifesciences announces study findings that support the use…
Edwards Lifesciences, has recently unveiled study findings endorsing the effectiveness of its Acumen HPI software. Data from the EU-HYPROTECT registry indicates that the implementation of Acumen HPI could potentially lead to a reduction in the severity and duration of intraoperative hypotension in non-cardiac surgery patients. In June, Edwards had previously presented registry results showcasing the software's achievements. The company developed Acumen HPI with the intention of providing medical professionals with insights into the likelihood of hypotension occurrence in patients. The software employs an algorithm that processes data from hemodynamic monitoring during perioperative management. Through predictive analytics, it alerts clinicians about potential drops in blood pressure before they happen. Acumen HPI received FDA 510(k) clearance in June 2022. This European multicenter prospective observational registry involved 702 patients in its final assessment. These patients, who were scheduled for elective major non-cardiac surgery, were sourced from 12 medical centers spanning five countries. Edwards highlights that this marks the first multicenter registry to incorporate predictive monitoring technology, creating a substantial, prospectively gathered hypertension management database. All patients underwent intraarterial blood pressure monitoring via an arterial catheter, coupled with intraoperative utilization of the Acumen HPI software. The primary focus of Edwards was intraoperative hypotension, assessed using the time-weighted average mean arterial pressure (MAP) of less than 65 mmHg. Secondary objectives comprised the proportion of patients with at least one episode of MAP dropping below 65 mmHg for a duration of one minute or longer. It also encompassed the count of episodes of MAP below 65 mmHg lasting at least one minute. The registry enrolled 749 patients from September 2021 to May 2022, with 702 subjects included in the final analysis. The median time-weighted average MAP below 65 mmHg was recorded at 0.03. Edwards reported that 285 patients (41%) had no MAP episodes exceeding one minute, with a median count of one such episode. Additionally, Edwards noted that although the study was not specifically powered for this aspect, instances of acute kidney injury were observed at the lower end of the typical range for patients undergoing major non-cardiac surgery. “The consequences of the COVID-19 pandemic have drastically accelerated the need for solutions that improve patient safety and outcomes, reduce hospital length of stay and increase hospital efficiencies,” said Edwards senior director of medical affairs, Thomas Scheeren. “The results of the EU-HYPROTECT registry are promising and demonstrate the need to better monitor hypotension in the perioperative pathway. Improving patient safety and outcomes is our ultimate goal and we believe the use of predictive monitoring can help achieve this.”
Smith+Nephew launch REGENETEN Bioinductive Implant in India for rotator…
Smith+Nephew, the global medical technology firm, has officially introduced its REGENETEN Bioinductive Implant in the Indian market. This innovative implant has already transformed the approach to rotator cuff procedures worldwide, having been used in over 100,000 surgeries. The REGENETEN Bioinductive Implant, crafted from collagen, leverages the body's natural healing response to stimulate the growth of new tendon-like tissue. By augmenting the existing tendon and altering the course of disease progression, this implant is inserted arthroscopically through a small incision precisely over the affected rotator cuff tendon area. Sized similarly to a postage stamp, the implant gradually becomes indiscernible within six months. During this period, the development of new tendon-like tissue and organized collagen, indicative of functional loading, takes place. Having already demonstrated its clinical effectiveness over a span of more than a decade through 18 studies encompassing the entire spectrum of rotator cuff issues, the REGENETEN Bioinductive Implant enters the Indian market. Its applications range from addressing partial thickness tears to addressing substantial full-thickness tears of varying sizes. A recent triple-blinded randomized controlled trial underscored the implant's significance, revealing an impressive 86% reduction in re-tear rates at 12 months when combined with conventional rotator cuff repair procedures, as compared to conventional surgery alone. The prevalence of rotator cuff ailments in India was estimated at 150,000 cases in 2022, leading to approximately 28,000 rotator cuff repair surgeries. Anticipated growth indicates that the total rotator cuff repair market in India will encompass 33,000 cases in 2023 and reach 39,000 in 2024, showcasing a year-over-year expansion of 15%. Joaquin Lasso, Managing Director, South Asia for Smith+Nephew, expressed enthusiasm about the REGENETEN Bioinductive Implant's introduction in India. Highlighting the evident clinical success, Lasso emphasized the implant's transformative impact on rotator cuff repair, yielding positive outcomes for numerous patients around the globe. The REGENETEN Bioinductive Implant forms a pivotal component of Smith+Nephew's comprehensive Advanced Healing Solutions portfolio, which is redefining the landscape of biological healing in rotator cuff repair.

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