Striking Out Against Stroke
Predicting, preventing, and treating stroke has always been challenging for drug and device developers. The sheer number of potential patients and the current scarcity of safe and effective treatment options make this one of the most intriguing markets. Innovation in the device arena continues at a slow but steady pace, and clinicians and patients are beginning to reap the benefits of recent advances.
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The International Stroke Conference, held in San Diego in February 2009, presented several device-based therapies and approaches that could offer improved outcomes for patients that suffer an acute ischemic stroke. The technologies discussed included mechanical thrombectomy devices, laser treatments, and combined therapy using ultrasound, microspheres, and thrombolytic drugs.
If the 1990s was the decade of the heart, this was supposed to be the decade of the brain. But the tremendous market for stroke device companies has never quite materialized in part because stroke treatment is so elusive. That elusive nature of therapy has led also to unclear technology solutions, complex regulatory paths, and challenging adoption models. CoAxia is staking its claim with a development and clinical trials strategy that departs from those of other stroke start-ups, aiming to prove clinical efficacy in its complex trials.
Over the past several years, device manufacturers have introduced a number of PFO closure devices in Europe, but conducting randomized trials to gain US market approval has proven to be a much more difficult endeavor. Companies have experienced numerous delays and setbacks in both their stroke and migraine programs. The good news: setbacks for some could also boost randomized migraine studies still ongoing by other competitors in this field.