Transcatheter Cardiovascular Therapeutics 2023 (TCT 2023) conference, the annual scientific symposium dedicated to cardiovascular interventional medicine, took place from October 23-26, 2023, in San Francisco, U.S. Experts in cardiovascular fields from around the world gathered to share new breakthroughs, discuss academic hotspots, explore the cutting-edge technologies and the future development trend. At TCT 2023, Peijia Medical showcased a number of self-developed and jointly developed innovative products, highlighting the company’s complete and competitive pipeline.
❖ The Iteration of Peijia’s Taurus-Series Products
At the WorldLink Forum on the first day of the conference, Academician Junbo Ge, from Zhongshan Hospital at Fudan University, gave a keynote speech titled “Innovations in Structural Heart Diseases from China”. He presented China’s advancements in the field of interventional structural heart disease interventions to the global experts at the conference. The interventional therapy of structural heart disease has been developed in China for over a decade. Domestic devices have been consistently optimized and iterated, transforming from early exploration to independent innovation.
Since the launch of TaurusOne®, the first-generation transcatheter aortic valve replacement (TAVR) product in April, 2021, Peijia Medical had been constantly exploring structural heart interventional therapies and have now established a comprehensive pipeline covering all major diseases. TAVR devices has iterated from TaurusElite®, the second-generation retrievable system, to TaurusNXT®, the third-generation nonglutaraldehyde cross linked dry-tissue system, and further to TaurusApex®, the fourth-generation polymeric leaflets system. Meanwhile, through external BD and internal development, Peijia Medical has introduced a large number of innovative devices to its product portfolio to fulfill unmet clinical needs and address unsolved clinical pain points, including the licensed-in transseptal mitral valvereplacement (TSMVR) system HighLife® , aortic regurgitation (AR) TAVR system JenaValve TrilogyTM, jointly developed transcatheter tricuspid valve replacement (TTVR) system MonarQTM, and the novel internal-developed transcatheter edge-to-edge repair (TEER) system GeminiOne® .
❖ JenaValve Announced the Initial Outcome of ALIGN-AR Pivotal Clinical Trial
On October 24, 2023, JenaValve Technologies Inc. (JenaValve) announced results from the ALIGN-AR Pivotal Trial for the Trilogy™ Transcatheter Heart Valve (THV) System in high-risk patients with symptomatic, severe aortic regurgitation (AR). The trial met prespecified non-inferiority criteria for its primary safety endpoint and primary efficacy endpoint. Outcomes were presented by Dr. Vinod Thourani (Piedmont Heart Institute, Atlanta, GA) during the opening Late-Breaking Clinical Trial sessions at TCT 2023 conference.
The ALIGN-AR trial is a landmark prospective, single-arm investigation device exemption (IDE) study designed to assess the safety and efficacy of the Trilogy™ THV System in high-risk patients with symptomatic, severe AR. Results from the study are intended to support a Premarket Approval submission to the U.S. Food and Drug Administration (FDA). If approved, the Trilogy™ THV System would become the first and only transcatheter aortic valve replacement (TAVR) system in the U.S. indicated for the treatment of symptomatic, severe AR. Peijia Medical obtained the exclusive right of JenaValve TrilogyTM THV System in the Greater China region through a collaboration and license agreement in December 2021. The System has been commercially implanted in Hong Kong and the pivotal clinical trial in China is progressing smoothly. In the future, JenaValve TrilogyTM THV System will join Peijia’s Taurus product family under the name of TaurusTrioTM, providing Chinese AR patients with an effective treatment solution.
❖ Peijia Medical Presents Early Clinical Findings of GeminiOne® TEER Device
On October 26, 2023, Dr. Saibal Kar, MD, Program Director of Cardiology at Los Robles Regional Medical Center and Physician Director of Interventional Cardiology at HCA Healthcare presented Peijia GeminiOne® TEER technology, along with the early clinical experiences of the device.
GeminiOne® is a novel TEER device that is designed to allow a longer coaptation length and minimized SLDA with sustained reduction in mitral regurgitation (MR). The thirty-day results (35 cases) reported no death, major adverse events, or conversion to surgery. Postoperative echo measures showed that 100% of the 35 patients had significant improvements in MR and maintained MR severity at 1+ or below at 30 days. “Right from the beginning, GeminiOne® design focuses on simplified clinical procedure with better performance. We are very encouraged by the early clinical results, and also being confident about the clean IP position of that design,” said Dr. Yi Zhang, Chairman and CEO of Peijia. “With its intuitive design and promising clinical performance, we believe it will be the pioneering product for Peijia's global footprint.”
GeminiOne® is currently undergoing a multi-center clinical study in China with 20+ enrolling sites. The pivotal study is intended for the treatment of high risk, symptomatic degenerative mitral regurgitation patients. The early feasibility study in the U.S. is expected to commence in 2024.
❖ Latest Update on Transcatheter Mitral Valve Replacement (TMVR)
At the TMVR Innovation Forum, Dr. Nicolo Piazza, from McGill University Health Center gave an update on the latest progress of HighLife® TSMVR system. HighLife® TSMVR system adopts a unique “Valve-in-Ring” concept, which makes it self-centering and selfaligning. The 2-component design respectful for mitral valve anatomy can be adapted to a large majority of patients.The design of the system can mitigate the risk of paravalvular leakage and effectively reduce catheter size. HighLife® now has a global experience with 100+ procedures in the U.S., Europe and Australia. Based on existing clinical feedback, the design of the system has been optimized to better adapt to the anatomy. The pivotal clinical trial of HighLife® is underway in China. The experience in China will further promote the technology development of TSMVR globally.
❖ Clinical Exploration in TTVR
At the Tricuspid Valve Emerging Science and Research Forum, Dr. Arshad Quadri, MD, from inQB8 Medical Technologies Inc. (inQB8) presented the first-in-man (FIM) experience with MonarQTM TTVR system.
The first patient was diagnosed with severe tricuspid regurgitation and tricuspid valve dilation. After careful preoperative evaluation and procedure design, MonarQTM valve was successfully implanted through transjugular route. The follow-up echo and CTA at 8 months showed that the valve was positioned well and no residual regurgitation and PVL. The excellent preliminary results of the FIM case provided solid evidence of the novel device’s safety, feasibility and efficacy. The next-phase clinical trial of the system is expected to launch in 2024.
