Tai Mei Ti A P P·2025-12-22 09:23Core Viewpoint - The ongoing debate in the academic community regarding the definition and standards of artificial heart technologies is crucial for patient safety and clinical outcomes [2][3][8]. Group 1: Technical Definitions and Standards - The definition of "full magnetic suspension" in contemporary durable rotary blood pumps is ambiguous, leading to potential misinterpretations of product safety [2][4]. - Experts emphasize that any blood pump relying on fluid dynamic bearings in its primary operating mode cannot be classified as "full magnetic suspension" [2][8]. - A recent paper by Dr. Kurt Dasse highlights the need for clear definitions and evaluation standards for different bearing technologies in artificial hearts [3][8]. Group 2: Key Characteristics of CorHeart 6 - The CorHeart 6 device is categorized as a "centrifugal pump with magnetic-assisted dual fluid dynamic bearings" in authoritative literature, yet its manufacturer describes it as a "full magnetic suspension device" [4][24]. - Key specifications of the CorHeart 6 include a rotor speed range of 2200-4300 RPM, a device height of 26 mm, a diameter of 34 mm, a weight of 90 g, and a power consumption of 2.6 W at 2.0 L/min [5][24]. Group 3: Consensus on Magnetic Suspension - Experts at the ISMCS conference reached a consensus that true magnetic suspension must rely solely on magnetic forces for rotor stability across multiple degrees of freedom [14][20]. - The safety threshold for suspension gaps is established at ≥200 microns for full magnetic suspension, contrasting with ≤100 microns for fluid dynamic bearings [20][24]. - Stability verification methods, such as air testing, are proposed to ensure that magnetic bearings can maintain rotor suspension without fluid assistance [23][24]. Group 4: Clinical Implications and Data Transparency - The distinction between bearing technologies is critical as it directly impacts blood compatibility and patient outcomes, with fluid dynamic bearings showing significantly higher mortality risks compared to full magnetic suspension devices [24][25]. - The lack of long-term clinical data and transparency in the CorHeart 6's public disclosures raises concerns about its safety and efficacy [24][25]. - The industry is urged to adopt standardized definitions and transparent data sharing to enhance patient safety and foster innovation [24][25].