In the intricate domain of medical device design, innovation seems to be boundless. While there exists multiple innovations to supplement the fundamentals of human life, some of these innovations stand more instrumental as compared to others. One such domain that usually supersedes others is the Aortic Valve, one of the four valves connected to the heart, as it is the most prone to mishaps or outright failure.
It is in the quest for enhancing patient care that experts like Mr. Rajesh Kandula, Principal R&D Engineer at JenaValve Technologies, are spearheading benchmark initiatives. Rajesh’s work is centered around one of the most critical components of the human heart, the Aortic valve. Among the numerous valves within the human heart, it’s the Aortic valve that holds the unfortunate distinction of having the highest failure rate. Mr. Rajesh Kandula finds his expertise in designing products using engineering mechanics and Finite element analysis tools and characterizing products and materials, one of the most crucial steps in the entire process.
He explained that in recent years, medical science has witnessed a transformative shift towards minimally invasive procedures, and this shift has reverberated significantly in the realm of cardiac care. Transcatheter Aortic Valve Replacement (TAVR) has emerged as a game-changer in addressing Aortic valve diseases. It offers an alternative to traditional open-heart surgeries by enabling the implantation of the Aortic valve without the need for extensive surgical procedures.
“Two prevalent conditions that affect the Aortic root are Aortic regurgitation (AR) and Aortic stenosis (AS). If left unattended, these conditions can culminate in severe illness and even death.” he stated. “While TAVR has shown remarkable success in treating Aortic stenosis, its effectiveness in addressing Aortic regurgitation has been somewhat less pronounced and this is where the JenaValve device comes into play.” he added.
JenaValve’s Trilogy device stands out because of its proprietary locator clipping mechanism that is used to anchor the Transcatheter Heart valve to leaflets. This innovative technology ensures accurate alignment with the native anatomy, which is a significant advantage for treating Aortic Regurgitation, a condition that poses life-threatening risks. Recognizing the urgency and importance of addressing Aortic Regurgitation, the U.S. The Food and Drug Administration (FDA) has granted a breakthrough designation to expedite the device’s development and review process.
Mr. Kandula played a pivotal role in this transformative venture. As Principal R&D Engineer at JenaValve, he leads the charge in designing and developing Trilogy valve. The development process involves a rigorous Finite element analysis to ensure the new valve’s reliability and durability, and a series of tests to characterize the material and heart valve components.
“These encompass non-linear structural simulations designed to assess the behavior of the transcatheter heart valve (THV) during critical processes like crimping and in-vivo loading. The focus here is on evaluating strain limits on the stent frame and the durability of the leaflets.” he stated. These non-linear structural simulations play an integral role in the Accelerated Wear Testing (AWT) process, enabling the estimation of strains on the stent frame, with the ability to adapt test fixtures as needed.
Conclusively, the work undertaken by Rajesh and the JenaValve team represents a significant leap forward in the field of transcatheter heart valve replacement. His dedication and expertise exemplify the transformative power of innovation in the world of medical device design. With a renewed focus on addressing Aortic Regurgitation, a condition that affects countless lives worldwide, its innovative approach promises to bring hope and improved treatment options to patients and healthcare providers alike.
As it continues its relentless pursuit in the realm of cardiovascular medicine, the potential for saving lives and enhancing the quality of life for those affected by Aortic Regurgitation and Aortic Stenosis becomes increasingly promising.