Haemonetics to buy Attune Medical for $160M. Attune’s device to help cool the esophagus during radiofrequency ablation procedures is a key piece of the acquisition. #Haemonetics #Ablation #RFAblation.
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#MRI_Safe_Biopsy_Needle Market Expansion Projected to Gain an Uptick During 2023-2032 https://lnkd.in/dv4mhDyD The increasing preference for non- invasive #method of obtaining tissue from the #patient is primarily driving the #market growth. The benefits associated with #MRI safe biopsy needles such as less tissue #damage and the absence of exposure to #harmful radiation are again accelerating the #demand in the market. Olympus Corporation Hologic, Inc. Argon Medical Devices, Inc. SOMATEX® Medical Technologies BD STERYLAB CR Bard Medtronic Cook Medical Boston Scientific Cradiac
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Executive Research & Development Leader Specialized in Product Development & Portfolio Management | Veteran
Johnson & Johnson is seeking FDA approval for its Varipulse pulsed field ablation (PFA) system, which has already been cleared in the EU and Japan. The Varipulse is J&J's latest offering in the PFA market and features a multi-electrode catheter, PFA generator, and 3D mapping software to improve AFib ablation sales. J&J CEO Joaquin Duato has highlighted the importance of Carto software mapping for procedural efficiency and supporting a low to zero fluoroscopy workflow. However, J&J will face stiff competition from Boston Scientific, Medtronic, and Abbott, with the latter predicted to enter the US market by 2026. Despite this, J&J's electrophysiology unit has seen nearly 25% growth in the last quarter. Stay tuned for updates on FDA approval and market competition. #Healthcare #MedicalTechnology #FDAApproval #AFib #Electrophysiology #MedicalDevices
J&J files for FDA approval of Varipulse pulsed field ablation platform
medtechdive.com
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We had great discussions in our packed lunch symposium at New York Valves! Presenters and audience members discussed biomimetic valve design, hemodynamics, and flow dynamics. At Anteris, we believe that in order to mimic the performance of a healthy aortic valve, the replacement valve should be designed like a native valve. This led us to develop a new class of TAVR, a biomimetic valve that is constructed from a single piece of anti-calcification tissue, molded to be native-shaped. DurAVR™ THV is the first and only #TAVR valve to demonstrate laminar flow, both on echo and CMR. We are excited about the promising results from the US Early Feasibility Study and First-in-Human study and are preparing for a larger pivotal trial. Learn more about DurAVR THV: https://bit.ly/3QYCqnw #NYValves2024 #TAVI #aorticstenosis #laminarflow DurAVR™ INVESTIGATIONAL USE ONLY. NOT AVAILABLE FOR COMMERCIAL SALE. EU: Exclusively for clinical investigations. US: CAUTION – Investigational Device. Limited by Federal (or United States) law to investigational use.
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📢Nevro gets FDA nod for Nevro1 sacroiliac joint fusion device without lateral screw Nevro1 is an integrated transfixing device. It is said to transfix the sacroiliac joint immediately and provide the chance for long-term fusion. The ilium and sacrum are transfixed with self-contained, deployable titanium anchors. This improves the joint’s axial and rotational stability, US-based Nevro claimed. Additionally, Nevro’s proprietary instrumentation enables optimal intra-articular sacroiliac joint preparation, which is essential for achieving joint fusion. Nevro, a medical device company focused on chronic pain treatment, said that Nevro1 aids in the growth and eventual fusion of bone cells using its 3D-printed bone-growth boosting technology. Nevro CEO and president Kevin Thornal said: “Nevro1 will be our flagship SI joint fusion product as there is no other device like it on the market. “We now offer one of the most comprehensive portfolios of products in the SI joint space, and we can meet the preferences of different physicians and varying patient needs – ultimately helping to improve health outcomes and quality of life for patients.” This is the first regulatory clearance that Nevro has received since November 2023, when it acquired VYRSA™ Technologies. Read more online: https://lnkd.in/eDbBKWmp 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter #MedicalDeviceDevelopments #nevro #bonehealth
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Medtronic receives #FDA approval for their Inceptiv™ closed-loop rechargeable spinal cord stimulator (SCS) 🧠 💪 It is the first of its kind to offer a closed-loop feature, automatically adjusting stimulation in real time to keep therapy in sync with daily activities. Traditional SCS devices may cause discomfort during certain movements, leading to suboptimal therapy experiences. Inceptiv is able to sense biological signals and maintain tailored stimulation, ensuring a more consistent and effective treatment. David Carr, VP and General Manager for Pain Intervention at Medronic said: "A new era for spinal cord stimulation technology is beginning, and with Inceptiv SCS, Medtronic is at the forefront," "For patients dealing with chronic pain, every day is a struggle. They deserve personalized and effective relief, without compromising future access to MRI. They deserve the comfort that the smallest and thinnest device on the market can provide. We are proud to offer the most cutting-edge solution available today with Inceptiv SCS." Medtronic will initiate the U.S. market launch of Inceptiv in the coming weeks. #neurotech #spinalcordstimulation #medicaldevice
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The CONFORMAL Early Feasibility Study (EFS) data one-year results demonstrated durable closure for LAAO indicated patients with 97.7% seal without significant (>3 mm) leaks at 12 months, comparing favorably with marketed devices.¹ The EFS data also confirmed an impressive 97% sizing correlation between TEE and angiography, to quickly confirm CLAAS device sizing.² 1. Gray W, Conformal Early Feasibility Study: 12 Months Results. Presented at TCT 2023 2. Gray W, Real-Time Atrial Appendage Assessment for LAAO-CLAAS Device Selection: Angiography vs TEE. Presented at CRT 2023 Visit the Conformal website to learn more about the CLAAS System. https://lnkd.in/d6XdifY2 Visit the Conformal website to learn more. https://lnkd.in/eFTc4h7F #Cardiology #LAAO #data #conformalmedical #claas #Afib #CRT2024 #CardioTech #InnovationInTheHeartOfDC #ConformalMedica #interventionalcardiology #electrophysiology CAUTION: Investigational Device The CLAAS System is limited by Federal (or United States) law to investigational use.
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🧬MedTech & Life Science Enthusiast | Founder at Proxima | Helping start-ups build, grow and scale global teams.🧬
There have been some great breakthroughs in the world of cardiovascular devices over the last several weeks! Magenta Medical Ltd. announced that it completed enrollment for the early feasibility study of its Elevate heart pump device! Congrats to David Israeli, MD and the team at Magenta Medical. 心擎医疗 magAssist announced that it received breakthrough device designation from the FDA for its NyokAssist ventricular assist device. The interventional VAD provides mechanical circulatory support for high-risk percutaneous interventions. It features a 9 Fr insertion size with a foldable catheter pump to facilitate insertion and removal. This reduces the vascular access and closure processes. AngioDynamics announced that it received FDA breakthrough device designation for its AngioVac system. The breakthrough nod includes proposed indications for the use of AngioVac in the non-surgical removal of vegetation from the right heart. CathVision announced that it received FDA clearance for its PVI Analyzer and Signal Complexity algorithms.The algorithms, as part of the suite of AI-powered analytics, integrate into CathVision’s ECGenius system. #cardiovascular #medicaldevices #fda
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🏥 In connection with the FDA’s recent approval of Edwards Lifesciences’ transcatheter tricuspid valve replacement device, here is some commentary from RQM+ Vice President of Intelligence & Innovation, Jaishankar Kutty, Ph.D., about the importance of the benefit-risk story within the target patient population under the aegis of the state of the art and standard of care, in justifying the quantity of clinical data. Jai also discusses certain aspects of uncertainty that will face other followers in this technology space. Finally, there is time spent on some critical post-market areas that regulators could be focusing on for this device, and they they almost certainly will be focusing on for other devices to follow (perhaps in the pre-market phase). 📊 🕒 Timestamps if you'd like to jump ahead: 00:00 Introduction and Basis of Approval 03:22 Clinical Data and Outcomes 06:14 Regulatory Uncertainties for Device Manufacturers 10:33 Post-Market Areas of Focus for Regulators #MedTech #Cardiology #FDAApproval
Insights on FDA Approval and Future Challenges for Transcatheter Tricuspid Valve Replacement Devices | MedTech Voices
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Four is more! More matters. If flexibility matters in soft tissue, shouldn’t in matter in bone? If (the ideal) size matters in soft tissue, shouldn’t it matter in bone? If margins matter in soft tissue, shouldn’t it matter in bone? If protecting nearby critical structures matter in soft tissue, shouldn’t it matter in bone? If reproducibility matters is soft tissue, shouldn’t it matter in bone? If the impact of impedence matters in soft tissue, shouldn’t it matter in bone? With Medtronic OsteoCool RFA, we offer MORE THAT MATTERS!!! #medtronicemployee Leah Rice Bobby Moonnumakal Brent Hinson, MBA Brett Smith Kyle Rathgeb William Bishop Hiten Chawla Jessica Dinges John McLeod
Four ways to go. The OsteoCool™ RF Ablation System gives you flexibility to treat painful bone tumors your way. OsteoCool™ RF Ablation gives you flexibility with a wide range of procedural options to fit the needs of your patient. You can choose from multiple active tip sizes or perform simultaneous ablation using two probes. Go to Medtronic Academy to learn more about customizing ablation zones: https://lnkd.in/e3XrA2ma See risk information: https://bit.ly/3uTZ0WB #MDTPainInterventions #OsteoCool
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Four ways to go!! #OsteoCool
Four ways to go. The OsteoCool™ RF Ablation System gives you flexibility to treat painful bone tumors your way. OsteoCool™ RF Ablation gives you flexibility with a wide range of procedural options to fit the needs of your patient. You can choose from multiple active tip sizes or perform simultaneous ablation using two probes. Go to Medtronic Academy to learn more about customizing ablation zones: https://lnkd.in/e3XrA2ma See risk information: https://bit.ly/3uTZ0WB #MDTPainInterventions #OsteoCool
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