Medical Ventures Inc., a Richmond, BC, Canada company, is releasing results from a clinical trial, titled GAAME (Gemini Angioplasty and Arterial Measurement Evaluation), that tested an innovative double balloon catheter. Gemini® catheter is designed to have a dual function, as it has the balloon that works as the measurement tool to evaluate arteries prior to dilation, as well as a angioplasty treatment balloon. Currently the device is promoted for use in peripheral arteries, but one doesn’t have to be a cardiologist to realize that the company would really want to see its device in coronary arteries everywhere.
Some of the reported results from the firm’s press release:
Metricath was used to measure reference vessels and to pre-dilate (open up) lesions prior to stent implantation in 62% of cases (90/145). Direct stenting (implantation of a stent without pre-dilating the vessel in advance) occurred in 38% of cases (55/145). In 43% of pre-dilation cases (39/90), Metricath measurements influenced the target diameter for the treatment area. In 49% of pre-dilation cases (44/90), Metricath measurements influenced the physicians’ stent size selection. Metricath measurements influenced the decision to post-dilate stents in 45% of direct stenting cases (25/55) and in 21% of pre-dilation cases (19/90).
Medical Ventures submitted a pre-market approval application for the device in November 2007 with the FDA.
Press release: Medical Ventures GAAME clinical update (.pdf) …
Product page: Metricath Gemini® balloon catheter …
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