A few days ago we covered the story of Claret Medical’s first-in-human study using its original CE Pro embolic capture device. At the time we felt there were a few unanswered questions, so went back to Claret for some more information. This after all is a very promising looking device with genuine patient welfare consequences.
As a reminder, the principle on which Claret’s cerebral embolic capture devices work is that they act as intraluminally inserted, user deployable filters which are placed in two critical locations, the innominate (brachiocephalic) artery and the left common carotid artery, thereby covering all arterial blood flow to the brain. Once in place they will capture embolic debris (see image below) from coronary interventions which can then be performed in the knowledge that risk of neurological embolism-related problems such as stroke or transient ischaemic attack are minimised.
So, the points of clarification relate to the difference between CE Pro and the newer Montage product:
Claret Medical attained CE Mark on its CE Pro system in August of 2011 and followed up with device improvements releasing its Montage in November of 2011 with a second CE Mark. The Montage has significant improvements including a central 0.014″ guidewire lumen and now employing the company’s own distal filter.
Claret says the Montage system has notably decreased the delivery times and physicians have commented that the ease of use is much better. In some instances the total delivery time has been under 2 minutes but on average about 3-4 minutes.
Claret Medical is planning additional clinical trials with the Montage and is only selling the device in a limited number of centres due to current production capacity.
Thanks to Claret for the information.
Source: Claret Medical