BioIntelliSense, Inc’s Post

One of the hottest topics this year in the #TAVI business, the #SMART trial one-year outcomes were published recently. First findings on this RCT were controversial discussed already Be smart and post your experiences and comments here. It is worth it to exchange experiences, opinions and feedback on this important trial in TAVI when it comes to small annuli and clinical outcomes. #patientsfirst Let‘s also take the opportunity to share experiences during this year’s #EuroPCR in #Paris when it comes to clinical outcome in small annuli comparing intra- vs. supra-annular valve design #smarttrial #europcr #patientsfirst #tavi

More than 3,900 patients have been treated in clinical studies with Pantera Lux drug-coated balloon (DCB), investigating coronary DCBs for various indications. Listen to Hee Hwa Ho, who summarizes the benefits of coronary DCBs beyond ISR. Find out more about Pantera Lux and its clinical data 👉 https://ow.ly/8YxY50PY1rf #BIOTRONIK #PanteraLux #WhatWouldYouChoose

Radiation dose is elegantly defined as simply a measure of energy absorbed per unit mass. However, calculating the biological impact of radiation on humans can be complicated, as it depends on several factors. Currently, radiopharmaceutical trials are frequently stopped because of conventional dose limitations for organs at risk. However, it's becoming increasingly apparent that these limitations may be too conservative and unsuitable for radiopharmaceutical therapies. This just-published paper in JCO by Ana Kiess et al. highlights this issue. It presents solid recommendations for phase 1 clinical trials, which could be used to establish appropriate tolerances for organs at risk in radiopharmaceutical therapies. This is excellent work by the RTP-TEC group; they have additional important manuscripts in progress. ##teamwork #radiopharmaceuticals #RPT #theranostics Ana Kiess Joe O'Donoghue Carlos UribeLisa Bodei Adam Kesner George Sgouros Society of Nuclear Medicine and Molecular Imaging (SNMMI) European Association of Nuclear Medicine (EANM) American Society for Radiation Oncology American Association of Physicists in Medicine Oncidium foundation

We need to understand the dose and biology as we move towards individualized therapy and treatment combinations. This is an great paper to understand where we need to go!

The #SMARTtrial reveals that Evolut™ #TAVR delivers 5x less bioprosthetic valve dysfunction (BVD) in women vs. SAPIEN platform at 1 year.¹ Explore the evidence: https://bit.ly/4aryVhk Risk Info: https://bit.ly/49AjEJz TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker. 1. Herrmann H, et al. Self-expanding Versus Balloon-expandable Transcatheter Aortic Valve Replacement in Patients With Small Aortic Annuli: Primary Outcomes From the Randomized SMART Trial. Presented at ACC: April 2024.

Yesterday, we hosted an insightful webinar with Prof. Duncan McLaren! Prof. McLaren discussed the PACE B study, highlighting potential links between acute GU toxicity and late toxicity. Some data also suggest that the use of fiducial markers and a regular LINAC also might be associated with higher toxicity. A key question raised: What are the benefits of using a catheter in prostate SBRT? This will be investigated in the upcoming PRECISION trial, a phase 2 study launching soon in the EU and US. The team in Scotland is just weeks away from enrolling their first patient, with 100 patients being the initial goal for all starting centers. The conversation also revolved around how the urethra is becoming the “new kid on the block” in prostate SBRT. More professionals are recognizing the patient benefits of focusing on the urethra, which naturally integrates into the workflow when using a catheter that enables urethra outlining during SBRT. Interested in learning more? We’re considering a follow-up session later this fall. By then, several centers, including Edinburgh, will have started the three-fraction protocol. Thanks to Prof. McLaren and everyone who joined! #ProstateCancer #SBRT #Radiotheraphy #Raypilot

We enjoyed engaging with many of you at New York Valves! In case you missed our symposium, you can now watch the full recording here: https://bit.ly/3Rtt1EW Learn about: 💡The biomimetic DurAVR™ THV, shown to restore laminar blood flow through the valve. 💡The latest imaging techniques for assessing laminar blood flow and the data used to measure the impact. 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. We are dedicated to moving the conversation forward in TAVR, expanding valve science beyond traditional measures like EOA and MPG, and exploring new metrics and their impact on outcomes. #NYValves2024 #TAVI #TAVR #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.

This transaction is the fourth acquisition on J&J's part in the cardiovascular space in less than two years. The $1.7 billion figure for V-Wave is dwarfed by the $13 billion paid for Shockwave in April and the $16.6 billion J&J paid to acquire Abiomed in November 2022. Serious cardiovascular moves for J&J.

Exciting news today as Biosense Webster receives European CE mark approval for our VARIPULSE™ Platform, marking a significant step forward in treating cardiac arrhythmia with pulsed field ablation (PFA) technology. With estimates suggesting that by 2050, Europe will have the greatest increase in Atrial Fibrillation compared to other regions globally, this milestone not only signifies our commitment to innovation in cardiac care but also positions us here in Europe at the forefront of solving some of the most pressing challenges in cardiac care. Our focus now is working alongside physicians and healthcare providers, together with our leading clinical teams throughout the region to bring this technology to all those patients who can benefit. https://lnkd.in/edYARrJz #myCompany #CardiacCare #JNJMedTechProud #VARIPULSE #PulsedFieldAblation

Curious to learn more about our First-in-Human Study of BRB-002? Check out our press release here: https://lnkd.in/euhPue-g #BitterrootBio #BRB002 #FirstinHuman #heartdisease #cardiovascular #drugdevelopment