Large-Scale Clinical Analysis of J-Valve (Genesis MedTech) and JenaValve (Edwards Lifesciences) in Transcatheter Aortic Valve Replacement for Severe Aortic Regurgitation

Feb 24, 2025 15:00 CST Updated 15:00

Medtronic

Medical Device Manufacturer

Published an article about Jian Shi ( in the journal "Journal of the American College of Cardiology, JACC".J-Valve) and Edward (JenaValve) Analysis of a large clinical study on TAVR for reflux, the study showed that two types of valves performed well in treating high surgical risk patients with severe native aortic regurgitation (AR).

The author searched all studies on TAVR for the treatment of aortic regurgitation (AR) through PubMed, EMBASE, and Cochrane. The primary endpoint was 30-day all-cause mortality. Secondary endpoints included device success, residual AR ≥ moderate, valve embolization/displacement, pacemaker implantation, re-intervention, and all-cause mortality at 1 year. Pooled estimates were constructed using a random-effects model.

This study enrolled34 studies, involvingAnd 2,162 patients (mean age 75.4 ± 0.2 years, 42.8% female).

Specific Research Results

Patients treated with reflux TAVR had a lower 30-day all-cause mortality rate compared to conventional TAVR (stenosis) (3% vs. 9%; P<0.01) and a higher valve success rate (93% vs. 82%; P<0.01).
In the anti-reflux TAVR group, the risks of AR ≥ moderate (2% vs 5%; P=0.03), valve embolization/displacement (2% vs 8%; P<0.01), pacemaker implantation (11% vs 20%; P<0.01), and reintervention (4% vs 10%; P<0.01) at 30 days, as well as all-cause mortality at 1 year (6% vs 24%; P<0.01), were all lower.

Conclusion

RefluxTAVR andTraditional TAVR (Stenosis）In comparison,RefluxTAVRDemonstrated superior device success rates and reduced mortality, residual AR, and re-intervention rates. These findings support the use ofRefluxTAVRAsAortic Regurgitation (AR)A Safer Alternative for High-Risk Patients.

Last year, Edwards acquired JenaValve Technology (JenaValve) and J-Valve (Jian Shi), compared to full acquisitionsJenaValve Technology, Edwards Acquisition OnlyJian Shi TAVR Product Overseas Rights, Jian Shi Retains Greater China Rights.Edward simultaneously launched two of the best products on the marketRefluxTAVR in the bag, this is a short-term complete block for Medtronic in the reflux field, making it impossible for Medtronic to pose a threat to Edwards in the short term.

Last year was an incredibly difficult year for Edwards. Regardless of clinical research or market pressure, Medtronic exerted tremendous pressure on Edwards. Moreover, the growth potential of the TAVR (stenosis) market is also nearing its peak. As a result, Edwards’ TAVR business growth in Q4 last year was only6% is too slow for structural heart growth. ThereforeEdward AcquisitionJenaValve Technology andJian Shi's reflux TAVR becomes the biggest driver of TAVR business growth in the next few years. Among themJenaValve is expected to receive FDA approval this year, looking forward to Edwards' excellent performance in the TAVR field in the coming years.