CE Mark Anticipated 2010
One of the aims and advantages of interventional cardiology is the increased ambulation of the patient post procedure and the minimization of invasive elements within the procedure.
Published studies show that direct stenting decreases the number of steps necessary to complete a procedure in addition to reducing complications and improving outcomes. By combining an integrated inflatable balloon into the Acrobat SOAW device, implantation and deployment of the device may be achieved without pre-dilation of the vessel, while assuring the lesion will be adequately compressed to allow the vessel to receive the stent.
Additionally, published studies have shown that smaller introducer sheaths equate to less chance of bleeding and faster wound healing, thus faster patient ambulation. The incredible low profile of the Svelte Acrobat allows for the downsizing of introducer sheaths and guiding catheters in many patients.
Svelte Acrobat First in Man Study
Clinical Evaluation Sites:
Erasmus Medical Center
Patrick W. Serruys, MD
Rotterdam, the Netherlands
Utrecht Medical Center
Pieter R. Stella, MD, PhD
Utrecht, the Netherlands
Instituto Dante Pazzanese de Cardiologia
Alexander Abizaid, MD
Jose de Ribamar Costa Junior, MD
Sao Paulo, Brazil
Instituto Cardio-Neuro-Vascular CORBIC
Andres Fernandez, MD
Juan Granada, MD
Medellin, Colombia
Results
Preliminary analysis of 30-day post procedure data is anticipated to be available by the end of July, 2010. A full clinical report is expected by fall 2010.
Additional Studies
Svelte is presently in active development of protocols for a larger IDE (Investigational Device Exemption) Study slated to commence in the first calendar quarter of 2011. The trial will enroll approximately 350 patients from 20 sites primarily across the United States.
