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Medtronic trial results confirm technologies to reduce major cardiac events

Medtronic : 23 October, 2007  (New Product)
Medtronic has announced the findings from its AMEthyst and Export clinical trials that highlight the ability of next-generation technologies to improve patient outcomes following interventional procedures.
Results of the AMEthyst and Export trials were presented at the 19th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.

The AMEthyst trial was an 800 patient, US based multicentre, randomised trial to evaluate the safety and efficacy of the Interceptor PLUS Coronary Filter System as an adjunct to percutaneous interventions on saphenous vein bypass grafts (SVGs).

The findings demonstrate that when compared to commercially available control devices (Medtronic’s Guardwire Temporary Occlusion Balloon and Boston Scientific’s Filterwire EZ), Medtronic’s new Interceptor PLUS Coronary Filter System works equally well in reducing major adverse cardiac events (MACE).

Medtronic also announced new findings from the Export trial, a study assessing the safety and efficacy of the Export Aspiration Catheter, a device designed to remove thrombus and embolic material that is present in many blood vessel lesions and may become dislodged during interventional procedures.

The study, a randomised, controlled trial of 250 patients at 24 sites in Europe and India comparing the use of Export prior to Stent implantation with conventional stenting in patients with acute myocardial infarction (AMI), demonstrated the effectiveness of the Export Aspiration Catheter in improving blood flow in AMI patients.

A significant number of US patients undergo coronary artery bypass grafting (CABG) procedures each year.

The improved blood flow gives patients a new lease on life but, unfortunately, approximately half of these grafts can also become blocked or diseased over time. Moreover, they can become blocked by fragile, brittle and ‘friable’ atheromous material as they age. When this occurs, cardiologists perform Stent angioplasty to keep blood flowing through the vein grafts – a process that can also release showers of embolic debris. Embolic debris, if not contained, can flow downstream to result in blockages of tiny tributary vessels and trigger ‘microinfarcts’, or tiny heart attacks that destroy areas of heart muscle.

The Medtronic Interceptor PLUS Coronary Filter addresses this problem through its design. A braided nitinol filter mounted on a 0.014inch hypotube, Interceptor PLUS is delivered in a closed state into the artery, moved past the blockage and opened before performing conventional Stent angioplasty.

The Interceptor PLUS Coronary Filter maintains blood flow in saphenous vein grafts while trapping the embolic debris. Data from the AMEthyst trial showed that Interceptor PLUS met the primary study endpoint to demonstrate safety, MACE at 30 days, indicating non-inferiority of Interceptor PLUS compared to control devices.

Interceptor PLUS also demonstrated efficacy with device success over 90 percent and a low incidence of clinical failure when compared to commercially available control devices.

Medtronic’s successful completion of this study enables the company to pursue 510(k) clearance with the FDA to market the device in the US Export XT Cleared for use in the US in 2006, the Export XT Aspiration Catheter design allows for superior deliverability in even the most demanding cases.

The full-wall variable braiding design helps eliminate segment joints and weak points in the Catheter to improve kink resistance, and allows enhanced deliverability due to seamless transition of shaft stiffness from one end of the Catheter to the other.

The device features a soft tip material with a short, bevelled design for minimal vessel trauma and improved debris capture, plus a hydrophilic coating for greater lubricity.

Since its introduction in 2001, the Export Aspiration Catheter product line has been used to remove embolic debris in more than 200,000 patients worldwide. Data from the Export trial found Export met its primary endpoint.

In patients presenting with an AMI, primary aspiration using the Export Aspiration Catheter is associated with a higher percentage of patients with ST segment resolution of greater than 50 percent at 60 minutes post procedure and/or a myocardial blush grade III immediately post-procedure than in patients with conventional stenting. In addition, primary aspiration using the Export Catheter is associated with a lower rate of no-flow, higher corrected TIMI frame count post procedure, and a lower requirement for bail-out techniques.

“These trials demonstrate the Medtronic commitment to innovate new technologies that are specifically designed to reduce the risks associated with interventional procedures,” said Sean Salmon, vice president and general manager of the Coronary and Peripheral business at Medtronic. “The performance of these new devices is well characterised and represents a significant advance in interventional cardiology.”
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