Conformal Medical’s Post

A First Step into bringing Novel US FDA Breakthrough technology to the US , A Giant Leap of Hope & Promise for US based Patients suffering from complex Coronary occlusive vascular disease . Concept Medical is proud to announce commencement of its Pivotal US FDA Investigational Devise Exemption Study for the treatment of Instent Restenosis with Magic Touch SCB - The World's 1st CE commercialized Novel Sirolimus Drug Coated Balloon , offering a safer and effective alternative for treatment of complex coronary disease such as InStent Restenosis . We are thankful to Dr Ajay Kirtane , Dr Azeem Latib , the principal investigators of the study and all the US study investigators supporting the enrollment and treatment in this pivotal multi- centered Randomised clinical trial. With Over 23K patients touched with Its clinical trial program with results that are altering standards of care and shaping the future of percutaneous treatment of occlusive vascular disease with over 180 K patients treated in real world setting with its solutions accross vascular disease , this milestone is indeed an important step to extend these proven technlogies to ailing patients in the US # Worlds 1st CE commercialized Sirolimus DCB #US FDA Breakthrough Devices # Largest and Longest Studied Clinical trial program touching over 23 K patients # over 180 K patients treated - Confidence Inspired by Real World Use.

#News Today, Biosense Webster announced the launch of CARTO™ 3 System Version 8, the latest version of the company’s leading three-dimension (3D) heart mapping system used in cardiac ablation procedures. The V8 software has new modules like CARTO ELEVATE™ and CARTOSOUND™ FAM. CARTOSOUND™ FAM introduces #AI to reconstruct left atrial anatomy and simplify workflow. Both modules enhance efficiency, reproducibility, and accuracy for electrophysiologists conducting catheter ablation procedures for #AFib patients. Despite significant progress in the field, #AFib impacts nearly 50 million people worldwide. This underscores the need for new and improved tools that help #EPeeps deliver optimal treatment for cardiac arrhythmias. I’m pleased to see Johnson & Johnson MedTech continue to raise the bar for innovative technology and make a difference for electrophysiologists and patients worldwide. Learn more: https://lnkd.in/gQAyY7Tg #JNJMedTechProud #MyCompany

Great news! The #SIMCor consortium has obtained a 6-month extension by the European Commission to consolidate and expand its work on #virtualcohorts and #insilicotrials in #cardiology, including mapping of engineering metrics with clinical outcomes and regulatory approval of #insilico tested medical devices. #SIMCor is a #H2020 #RIA developing a computational platform for #insilico testing and validation of #cardiovascular implantable devices.   Check out our mission👇 https://lnkd.in/dSXpF4Q3 #cardiovascular #modelling #simulation #insilicotrials 

Calyx’s #CNS experts lean on their experience and understanding of the custom requirements for #MultipleSclerosis studies to effectively and efficiently manage the #MedicalImaging components of these unique #clinicaltrials. Learn more. https://lnkd.in/g6mfJwke #ChooseCalyx

We are thrilled to share two-year late-breaking clinical results demonstrating a statistically significant benefit with DynamX® Coronary Bioadaptor System over standard-of-care Resolute OnyxTM Drug-Eluting Stent: ·     65% reduction in target lesion failure (TLF) rate ·     68% reduction in target vessel failure (TVF) rate ·     78% reduction in TLF rate in left anterior descending (LAD) artery lesions Learn more about the BIOADAPTOR Randomized Controlled Trial (RCT) results: https://lnkd.in/ecWk4dse CE marked. Not for sale in the U.S. #EuroPCR #Bioadaptor #Medtech #Innovation #Cardiology

Congratulations to Piraeus Medical, Inc. on their recent NINDS Phase I #STTR award for a project titled "Two-for-one Stroke Thrombectomy: A novel Dual DAC to enhance navigability, lumen size, aspiration efficiency, and persistent flow arrest in mechanical thrombectomy". One way to improve aspiration #thrombectomy technologies is to expand the inner diameter of distal access catheters (DACs). However, there are some disadvantages to this “one-size-fits-all” approach. In response to these challenges, PIRAEUS MEDICAL has designed a novel, two-component, telescoping “Dual DAC” system with the same inner diameter of other “Super Bore” DACs while achieving 8Fr short sheath compatibility.  The company also received a Phase II SBIR award for a project titled "Enabling rapid and effective stroke thrombectomy procedures from a transradial approach: Combining introducer sheath, guide catheter, and distal access catheter into a single device". They have developed and tested a novel SuperBore thrombectomy system appropriate for #transradialaccess which will undergo full, formal validation program guided by #FDAtesting criteria, followed by extensive benchtop, GLP animal, and cadaveric testing. Their “Wrist-to-Brain” thrombectomy system provides several advantages including 1) combining guide catheter and SuperBore DAC in a single catheter; 2) hyperthin walls enabled by a novel, proprietary liner; and 3) a highly trackable and kink resistant shaft that fits within the radial artery in most patients. #AcuteIschemicStroke

The Strategic Value of Intellectual Property in #MedTech: Why Expand your IP? In the dynamic landscape of medical technology, savvy investors recognize the power of intellectual property (IP). For those eyeing opportunities with breakthrough devices like the #MicroAngioscope and #BDAC, here's why IP is a game-changer: Competitive Positioning: IP ensures a device's unique stance in the market, reducing the risk of imitations. ROI Assurance: Protecting IP safeguards the substantial R&D investments, promising better returns for stakeholders. Investor Confidence: A robust IP portfolio not only attracts but also reassures discerning investors about the product's potential. Licensing & Partnerships: IP opens avenues for lucrative licensing deals and strategic collaborations. Global Market Penetration: With IP protection across regions, the device is poised for a successful global rollout. Reputation Enhancement: A strong IP stance signals commitment to innovation, bolstering company credibility. Legal Fortification: IP rights offer a solid defense mechanism against potential infringements. Innovation Catalyst: The pursuit of IP naturally drives continuous advancements in technology. Patient-Centric Approach: At its core, IP ensures that patients receive devices of the highest quality and safety standards. Thoughts? Leave a comment, like and pass along!

Ciliatech unveils a redesigned Cilioscleral Interpositioning Device (CID) for lowering intraocular pressure while minimizing risks. CID's unique approach can address open-angle and angle-closure glaucoma, offering a potential alternative to traditional methods. Recent patents focus on refining CID's shape and geometry for improved performance and safety. This second-generation CID, currently in clinical trials, promises a less invasive procedure with smaller incisions, benefiting patients and surgeons alike. Philippe Sourdille, Ciliatech's co-founder, notes the enhanced safety profile and IOP reduction, building on the first-generation's success. The new CID design optimizes water collection and circulation, yielding promising results in a 12-month clinical study (SAFARI III). Surgeons find it quicker and easier to use, reducing the learning curve. Ciliatech's non-resorbable CID ensures long-term biocompatibility. It's an exciting step in glaucoma treatment! #GlaucomaTreatment #Ciliatech #CID #FutureOfHealthcare #Healthcare Read more about this advancement at https://lnkd.in/gUbS35RU

Exciting news from Kardium Inc. in the fight against atrial fibrillation. The PULSE-EU trial tested Kardium Inc.'s novel PFA system called the Globe Pulsed Field System. The trial included 48 patients with paroxysmal or persistent AFib who underwent ablation targeting the pulmonary veins, posterior walls, and mitral isthmuses using this spherical array catheter. The results were highly promising: 💥 100% success rates for pulmonary vein isolation and posterior wall ablation  💥 91% success for mitral isthmus ablation 💥 Short procedure times (mean 87.8 minutes) 💥 84.2% freedom from atrial arrhythmia at 1 year for paroxysmal AFib 💥 80% freedom from atrial arrhythmia at 1 year for persistent AFib While still investigational and not yet FDA approved, the PULSE-EU trial data suggests the Globe PFA system could be a game-changer for catheter ablation. #EPeeps #EP #Electrophysiology #MedTech

Microtech Medical’s submillimeter, passive, implantable wireless sensors can read and transmit virtually any physiologically relevant parameter for the diagnosis and ongoing treatment of multiple disease states. *Investigational device, restricted to investigational use only. Not available for sale. #HeartFailure2023 #ESCHFA #Cardiology #innovation #RemoteMonitoring #PatientOutcomes #MedTech #HeartFailure #clinicalstudies #clinicaltrials #medicaldevices #medical #medicaldevice