The prevalence of migraine in the United States about 10 percent. Of the 28 million migraine sufferers in America, those who experience the aura and have a PFO are a three million patient subset. Stroke is the third leading cause of death in the United States and the leading cause of disability in adults. Each year, 750,000 Americans suffer a new or recurrent stroke and 500,000 Americans experience a TIA.
In conjunction with this decision, the company has called the FDA approval for a new PFO / stroke Investigational Device Exemption , CARS . The CARS IDE complement the company’s ongoing CLOSURE I clinical study to assess the association between PFO and stroke. The company is. Eligible patients of both CARS and CLOSURE I with newer NMT STARFlex implant technology the previously covered by the HDE only access to the Company’s original Cardio Seal device. The CARS IDE continues to PFO closure access to certain patients. Earlier for treatment under the HDE However, while patients in the CLOSURE I trial receive the implant at no cost, can be covered under the CARS IDE will be charged for the device.UroToday – the only one Urologist site to your original content by global urological key opinion leaders writing written clinical practice. To see the latest urology Press dated UroToday to access.