Signum Surgical ’s Post

✔️4C Medical Technologies, Inc. announced the FDA granted breakthrough device designation for its AltaValve system. The company received designations for two therapeutic indications for the transcatheter mitral valve replacement device. 👏Saravana Kumar, CEO and President commented: “This advancement enables us the opportunity to bring this needed technology to our patients even sooner.” 🔗Read more: https://lnkd.in/dJjiTFhJ 📰 Follow Guided Solutions to receive the latest #MedTech news daily and subscribe to our weekly newsletter: https://lnkd.in/dYC56Usw #MedicalDevices #MedicalDevice #MedicalEquipment #Medicine #Surgeons #GuidedSolutions

"The approval of cardiac devices over the last decade illustrates the apparent laxity and capriciousness of medical device regulation" Well then. Thought-provoking editorial at TCTMD from Dr. Sanjay Kaul, which uses a contrast in FDA approval decisions for patisiran (an RNAi for cardiomyopathy) from Alnylam Pharmaceuticals and the Evoque tricuspid valve replacement from Edwards Lifesciences. The author makes a distinction between the size and rigor of trials for pharmaceuticals and those for devices, particularly as it relates to the open-label nature and smaller size of many device trials, ultimately noting "these examples raise the question whether the current bar for FDA approval of new cardiac devices is too low, particularly when you consider the regulatory climate for medications." Far be it from me to opine on the widsom of the regulatory decisions discussed here (and many of the devices discussed have gone on to have long distinguished usage histories, including the MitraClip TMVR with 20 years of service and over 200,000 implants). However, can we in cardiac device community do better?? How do navigate the tradeoffs between regulatory speed (including Breakthrough Device designations), postmarket studies, and regulatory evidence? How do we generate 'blinded' results for device trials that do not include an inferiority endpoint (tough / obviously unethical to do a placebo device in the clinic!)? Tons of thoughts and directions to go here, but (and you knew this was coming from me), what role do #insilico methods have to play here?? Why can't we evolve to a place where every 'real' patient in the clinic has an #digitaltwin (to use the parlance of our times) to assess what would have happened without treatment? Why can't we use modeling techniques to generate more robust and larger sample sizes for regulatory decisions? Why can't we leverage #digitalhealth tools and #AI (buzzword alert!) to gather more natural history data for affected patient groups? I'm not saying this editorial is 'correct', but if these questions are being raised then what can we do to provide more evidence to support decisions and, ultimately, drive patient benefit forward faster? What do you think? Examples discussed in the context of regulatory decision making include: - MitraClip mitral valve repair (Abbott) - CardioMEMS Heart Failure monitoring (Abbott) - Watchman left atrial appendage occluder (Boston Scientific) - Impella 2.5 pump (Abiomed, now part of Johnson & Johnson MedTech) - Absorb bioresorbable stent (Abbott) - Amplatzer PFO occluder (Abbott) - AngelMed Guardian (Avertix Medical) - Paradise (Recor Medical) and Symplicity Spyral (Medtronic), both renal denervation

// Olympus said the policy changes remove barriers to access for physicians who recommend the iTind procedure. It increases the likelihood of iTind coverage, potentially fostering greater adoption.// // It offers an alternative to pharmaceutical therapy, surgeries and permanent implants. Olympus said it’s proven to relieve symptoms without affecting sexual and ejaculatory function or urinary continence.// Olympus Corporation #medicaldevice #surgical #procedures #alternatives

Knee Replacement Treatment: Globus Medical's Technologies Secure FDA Clearance The FDA has granted 510(k) clearance to Globus Medical’s ExcelsiusFlex with Total Knee Arthroplasty application and the ACTIFY 3D Total Knee System, marking a significant advancement in knee replacement treatment. The ACTIFY 3D Total Knee System, featuring cementless fixation and a porous lattice interface, supports both manual and robotic-assisted workflows, ensuring operative efficiency and anatomical fit. ExcelsiusFlex enhances surgical precision through robotically guided resections based on pre-planned implant placements. Daniel Scavilla, president and CEO of Globus Medical, highlighted the potential of these technologies to revolutionize knee replacement surgeries by improving precision, efficiency, and patient outcomes. For more details please click the link! https://lnkd.in/gwKprADg #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical 

Sun Pharma, Moebius Medical Present Positive Data From Phase 2b Trial Of MM-II In Painful Knee Osteoarthritis Patients At EULAR 2024 SUN PHARMA and Israel-based Moebius Medical Ltd. have presented data demonstrating the durability of pain relief achieved in symptomatic knee OA patients through 26 weeks post injection of MM-II. The results, presented at EULAR 2024, are based on an analysis from the randomized, controlled, Phase 2b clinical study (NCT04506463). MM-II is a novel non-opioid product that uses a proprietary suspension of large, empty, multilamellar liposomes which are intended to reduce friction and wear on the joint and thus relieve joint pain. Sun Pharma and Moebius Medical, who have been jointly developing this product, have announced plans to initiate a Phase 3 clinical program and to seek a CE Mark for the product in the European Union. Philip Conaghan Abhay Gandhi Moshe Weinstein For more information click on the link below: https://lnkd.in/gnYnwykA #sunpharma #sunpharmanews #moebiusmedical #oteoarthritis #EULAR2024

Exploring the Efficacy of Various Debridement Methods in Surgical Wound Healing A review of six studies on surgical wound debridement techniques found mixed results. Dextranomer beads or paste were not superior to other treatments, and enzymatic debridement had no significant advantage over saline dressings. Endoscopic surgical debridement may reduce healing time compared to open surgical methods. However, the overall evidence is uncertain due to bias and methodological limitations in the studies. More research is needed to establish definitive conclusions and improve patient outcomes in surgical wound management. For more details please click the link! https://lnkd.in/dXeNkt8m #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical

MedTech News & Trends: Cordis Secured FDA Approval for MYNX CONTROL VENOUS Vascular Closure Device, Expanding Proven MYNX Technology to Mid-Bore Venous Puncture Sites FDA Cleared Forma Medical Inc’s Optimal Plating System, Enhancing MIS Forefoot Portfolio Growth Virpax Pharmaceuticals Inc. (Nasdaq:VRPX) Reported Positive Outcomes from Swine Model Pilot Study for Probudur™ SetPoint Medical Reported Positive Topline Results from Pioneering RESET-RA Study on Neuroimmune Modulation for Rheumatoid Arthritis Signature Orthopaedics Partnered with THINK Surgical for Robotic Total Knee Arthroplasty  Nusano and PHARMALOGIC LTD Formed Strategic Supply Agreement to Boost Radiopharmaceuticals Get more details, at: https://lnkd.in/g6Ye_3-9 #lifesciences #pharmaceuticals #marketresearch #marketanalysis #healthcare #markettrends #health #medical #news #healthcarenews #medtech #medtechnews

Signati Medical has initiated enrollment of the inaugural patient in a clinical trial investigating its innovative device aimed at expediting vasectomy procedures. Operated under an investigative device exemption granted by the US Food and Drug Administration (FDA) in December 2023, the trial will evaluate the efficacy and safety of Signati’s Separo device for vasectomies. Vasectomy, a surgical procedure that involves cutting and sealing the vas deferens, the tubes responsible for transporting sperm from the epididymis, is the focus of this investigation. Signati asserts that its device can notably diminish procedure duration and provide a minimally invasive alternative. The Separo device purportedly seals each vas deferens within four seconds, according to the US company. Dr. Matthew Mutter, the principal investigator of the study, hinted at the stagnant landscape of vasectomy procedures, remarking that Signati’s efforts represent the "first major advancement in vasectomy technology in over 40 years." Among the additional benefits of this new approach, termed Sealed Vasectomy Procedure (SVP) by Signati, are reduced risk of bleeding and accelerated recovery. This technique involves solely sealing the tubes, contrasting with traditional methods that entail cutting. The system consists of a radiofrequency generator, a handpiece, and clamping forceps. The energy from the device cauterizes a segment of each vas deferens, permanently separating and sealing the ends.

Exploring the Impact of Surgical Waiting Lists on Quality-Adjusted Life Years A recent systematic review highlights the lack of data on the Quality-Adjusted Life Years (QALYs) lost due to surgical waiting lists (SWLs). The study found that there is a significant gap in knowledge regarding the impact of SWLs on patient quality of life. The review focused on various specialties and countries, with organ transplant surgeries being a major area of research. The willingness-to-pay per QALY varied across countries, indicating different economic valuations. The study emphasizes the need for targeted research to determine the impact of SWLs on patient outcomes and guide policy adjustments. For more details please click the link! https://lnkd.in/drW8fJVh #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical

Surgical Wound Debridement: Assessing Techniques and Outcomes in a Review Update A review of six studies on surgical wound debridement methods found mixed results. Autolytic debridement with dextranomer showed no superiority over other treatments. Enzymatic debridement with streptokinase/streptodornase had no advantage over saline dressings. Endoscopic surgical debridement showed potential benefits in reducing healing time. However, the overall evidence is uncertain due to biases and varied study quality. More robust trials are needed. Providers should consider the limitations and benefits of each method until more research is available. For more details please click the link! https://lnkd.in/dz6F3kHs #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical