IDE Approval for Ventana Fenestrated Stent Graft System

Ventana fenestrated stent graft system from Endologix, Inc has received Investigational Device Exemption (IDE) conditional approval from the FDA.

This approval allows the company to commence clinical trials of the device meant to treat juxtarenal and pararenal aortic aneurysms.

Study Points to New Way to Predict Death Risk from Torn Aorta
Each year, 10,000 Americans suffer a sudden tear in the lining of their body’s largest blood vessel, the aorta. It’s often misdiagnosed, and it can kill if not treated immediately.

This device is a new aortic extension meant to be used with AFX Endovascular AAA system and Xpand renal stent grafts, manufactured by the same company.

Presently, the Ventana and Xpand stent grafts is allowed only for investigation purposes.

Infants With Constricted Aortas may be Helped by Bailout Stenting
Successful stent implantation and follow-up coarctectomy in premature infants suffering from aortic coarctation has been achieved by cardiac interventionalists

Source-Medindia

Stent Better Than Open-Chest Surgery To Repair Damaged Aortas
Stents are better than open-chest surgery to repair damaged aortas, US researchers have shown.

Simple Score Helps Predict Patients With Aortic Dissection
An aortic dissection detection risk score is found to be effective in identifying and treating the conditions of acute aortic dissection, says U-M study.