TCT-106 BioInnovate Ireland: A Multidisciplinary Approach To Medical Device Innovation

Abstract

Յ18kg in 7/11). At baseline 6 patients were NYHA Class II and 5 were Class III. Clinical procedural success was achieved in 9/11. One patient experienced a major ischemic stroke (MRSϭ3 at discharge; final 90-day adjudication pending). A second had a mean post-procedure gradient of 22mmHg (above the 20mmHg VARC threshold) although the valve was functioning well (post-procedure AVA 1.6cm2). Partial resheathing was performed in 4/4 patients; none required full retrieval. Mean aortic gradient was 53.9Ϯ20.9mmHg at baseline and 13.7Ϯ3.7mmHg at discharge. Mean AVA was 0.7Ϯ0.2cm 2 at baseline and 1.5Ϯ0.2cm 2 at discharge. Paravalvular AR was mild in 2 patients, trivial in 1, absent in 8. Conduction disturbance requiring a new pacemaker occurred in 4 patients (2 with complete AV block). There were no deaths or MIs through 7 days. Conclusions: Early feasibility results suggest that the Lotus Valve can be positioned precisely and successfully with virtually no AR and low clinical event rates through discharge, supporting further study in a larger, more rigorous trial. Three-month data will be presented for the first time at TCT 2012.Background: Long-term blood-pressure (BP) monitoring is a vital necessity for physicians to prescribe appropriate medical treatment for malign hypertension patients in order to reduce the incidence of secondary consequences such as stroke, kidney failure or heart insufficiency. However, current devices are still not suited for long-term measurement (several weeks to months). Moreover, they usually measure the peripheral blood pressure which significantly differs to the central blood pressure known to be the better indicator for vascular diseases. In order to address this need, we developed and conducted in-vivo tests on a novel, fully-implantable, wireless blood-pressure monitoring system. Methods: The monitoring system was tested for six months in 12 chronic ovine models. The sensor was implanted with X-ray-control in the femoral artery by means of a dedicated sheath (PASIS). Reference measurements were recorded with gold standard pressure sensors after implantation. Position and proper functioning of the sensor were controlled via regular readout measurements and CTs. At the end of each trial, a histological examination was conducted. Results: Chronic in-vivo studies revealed that blood pressure measurement over a period of six months was possible with the novel implantable sensor system. Stable pressure histories were recorded. However, the mechanical resilience of the sensor system requires improvement. The in-vivo tests in the femoral artery of sheep produced high stress on the sensors system. Several implanted systems became inoperative despite efforts to stiffen the sensor-cable. The histological analysis detected no thrombi. Mild inflammatory reactions were found at the vessel insertion site in several cases. Conclusions:The results of the chronic in-vivo tests on the novel fully-implantable blood-pressure monitoring system were encouraging. Improvements need to be made regarding the mec...