June 18, 2007 — Kensey Nash Corporation today announced that it has completed a European Union (EU) study to assess the device success, safety and performance of the ThromCat Thrombectomy Catheter System during percutaneous coronary intervention (PCI).
The trial enrolled over 60 patients at seven sites, and was designed to study outcomes of patients in both acute and elective PCI settings, who had thrombus present in their native coronary arteries.
The ThromCat System is a mechanical thrombectomy catheter designed to remove thrombus in patients, and is indicated in Europe for use in both coronary and certain peripheral arteries.
Hospital discharge results, presented by the company at the EuroPCR meeting in Barcelona last month, demonstrated over 90% device success, patient safety and desired device performance with 70% thrombus removal by volume. The results of the study also showed strong improvements to TIMI flow measurements, and myocardial blush scores, based on the use of the ThromCat System, with only 1.6% of the patients needing temporary pacing.
The ThromCat mechanical thrombectomy system is a fully disposable catheter system that incorporates HeliFlex technology to flush, macerate, and extract thrombus. An internal rotating helix creates a powerful vacuum to draw thrombus into the catheter and then macerate it, while simultaneously flushing the vessel to aid in the thrombus removal.
For more information: www.kenseynash.com