06.02.15
A new study evaluating the Boston Scientific Lotus Valve System demonstrated an extremely low rate of paravalvular aortic regurgitation (leakage) for a transcatheter aortic replacement valve, plus a cardiovascular mortality rate of less than 2 percent at 30 days.
The 30-day results for the first 250 patients in the RESPOND postmarket study were presented at EuroPCR 2015 in Paris, France, by Nicolas M. Van Mieghem, M.D., co-principal investigator, Erasmus Medical Center in Rotterdam, the Netherlands.
Key findings include the following:
The company also reported rates and predictors for PVL from the REPRISE II Extended Cohort. Key findings in that trial, involving 250 patients evaluated at 30 days post implantation, include the following:
“These results are further evidence the Lotus valve design, its precise placement and redeployment capabilities and its low rates of paravalvular regurgitation can make a significant and meaningful difference in the lives of patients,” said Keith D. Dawkins, M.D., global chief medical officer for Boston Scientific.
The Lotus Valve System is a differentiated next-generation transcatheter aortic valve implantation (TAVI) device, consisting of a pre-attached, stent-mounted tissue valve prosthesis and catheter delivery system for guidance and percutaneous placement of the valve. According to the company, it is the first TAVI device to offer controlled mechanical expansion, allowing the valve to be fully deployed, assessed and then released, providing improved control during the procedure. The early valve function provides hemodynamic stability throughout the procedure and if necessary, the valve can be completely repositioned at any time prior to release. The device also features a seal designed to minimize the incidence of paravalvular regurgitation, which has been identified as a predictor of mortality in multiple clinical trials.
In the United States, the Lotus Valve System is an investigational device and not available for sale. It does have CE mark.
Aortic valve disease results in dysfunction of the aortic valve, one of the four valves that control the flow of blood in and out of the heart. Aortic valve stenosis is the process of thickening and stiffening in the valve, which can result in an abnormal narrowing of the aortic valve opening and reduction in blood flow. Aortic stenosis is a common problem affecting approximately 3 percent of the population older than 65 and 5 percent of people older than 75. From the onset of aortic stenosis symptoms, the average survival rate is 50 percent at two years and 20 percent at five years.
Boston Scientific is based in Marlborough, Mass.
The 30-day results for the first 250 patients in the RESPOND postmarket study were presented at EuroPCR 2015 in Paris, France, by Nicolas M. Van Mieghem, M.D., co-principal investigator, Erasmus Medical Center in Rotterdam, the Netherlands.
Key findings include the following:
- More than 95 percent of patients at hospital discharge had no or trace paravalvular aortic regurgitation (PVL), less than 5 percent had mild PVL, and no patients exhibited moderate or severe PVL (as assessed by an independent core lab);
- The cardiovascular mortality rate was 1.6 percent at 30 days; and
- The mean pressure gradient and effective orifice area measures used to assess the hemodynamic performance of the valve, were 10.1 +/- 3.7 mmHg and 1.9 cm2 +/- 0.4
The company also reported rates and predictors for PVL from the REPRISE II Extended Cohort. Key findings in that trial, involving 250 patients evaluated at 30 days post implantation, include the following:
- Nearly 86 percent of patients had either no PVL or trace PVL; less than 14 percent had mild PVL, and less than 1 percent had moderate PVL (as assessed by an independent core lab);
- No patients had severe PVL; and
- Significant independent predictors of PVL included device: annulus area ratio and calcium volume.
“These results are further evidence the Lotus valve design, its precise placement and redeployment capabilities and its low rates of paravalvular regurgitation can make a significant and meaningful difference in the lives of patients,” said Keith D. Dawkins, M.D., global chief medical officer for Boston Scientific.
The Lotus Valve System is a differentiated next-generation transcatheter aortic valve implantation (TAVI) device, consisting of a pre-attached, stent-mounted tissue valve prosthesis and catheter delivery system for guidance and percutaneous placement of the valve. According to the company, it is the first TAVI device to offer controlled mechanical expansion, allowing the valve to be fully deployed, assessed and then released, providing improved control during the procedure. The early valve function provides hemodynamic stability throughout the procedure and if necessary, the valve can be completely repositioned at any time prior to release. The device also features a seal designed to minimize the incidence of paravalvular regurgitation, which has been identified as a predictor of mortality in multiple clinical trials.
In the United States, the Lotus Valve System is an investigational device and not available for sale. It does have CE mark.
Aortic valve disease results in dysfunction of the aortic valve, one of the four valves that control the flow of blood in and out of the heart. Aortic valve stenosis is the process of thickening and stiffening in the valve, which can result in an abnormal narrowing of the aortic valve opening and reduction in blood flow. Aortic stenosis is a common problem affecting approximately 3 percent of the population older than 65 and 5 percent of people older than 75. From the onset of aortic stenosis symptoms, the average survival rate is 50 percent at two years and 20 percent at five years.
Boston Scientific is based in Marlborough, Mass.