A once-promising treatment for patients with ischemic stroke, intracranial atherosclerosis disease (ICAD) stenting has quietly burned out.
Big players Stryker and J&J were once invested in the space, each with a stent of their own. Currently, neither stent is marketed on company websites. Stryker's Wingspan stent is available for a very narrow subset of patients under FDA humanitarian device exemption (HDE). J&J's Pharos Vitesse recently received a final nail in the coffin in the form of poor safety and efficacy results from the VISSIT trial.
We?ve previously covered the hardships of neurovascular stenting through Sryker's Wingspan stent. To recap: the Wingspan stent was being studied in the SAMMPRIS trial, which was halted due to high complications and death rates associated with the device (full enrollment of VISSIT was also halted due to SAMMPRIS complications). The Wingspan has HDE status under the FDA, meaning that it can only be used in a maximum of 4000 cases per year. A consumer watchdog group called for the withdrawal of the Wingspan's HDE approval, but physicians were adamant that they needed the option to use the device in especially challenging cases. The HDE status was upheld by the FDA, but guidelines around patient selection were narrowed substantially.
After this debacle, we were left waiting to see if the results from VISSIT could prove effective and turn around the fate of neurovascular stenting, but just the opposite has occurred. The VISSIT trial underscores the safety concerns surrounding neurovascular stenting. FDA approval is now a distant fantasy for the Pharos Vitesse, and the sobering results of the trial will likely have a negative impact on the already small and declining ICAD stent market. In the case of ICAD, medical management has reigned supreme as the gold standard treatment.
Even in Europe, physicians have been looking toward theses FDA trials for guidance; I expect European physicians will also pull back on their ICAD use. Neither the Wingspan nor the Pharos Vitesse are being actively marketed in Europe anyway. We estimate that the entire European market will only be worth $1 million in 2015 ? hardly worth the attention of these multi-billion dollar medtech giants.
At the end of the day, this is a technology that will be made available to patients that need it, but do not expect much activity from this segment of the neurovascular market.