Medtronic Receives FDA Approval on Expanded Indication for Pipeline Flex Embolization Device

Medtronic plc announced that is has received FDA approval for its pipeline product, Flex embolization device. The approval was based on the basis of clinical data obtained from the study Prospective Study on Embolization of Intracranial Aneurysms.

Embolization devices are used to control hemorrhaging due to the blood clot or aneurysms and arteriovenous malformations. The embolization devices are used to block the blood flow to cerebral aneurysms and arteriovenous malformations. Whereas, the aneurysm coil is inserted through a use of catheter to fill in a brain aneurysm. The device is use to stop ruptured aneurysms that can cause continuous bleeding. The coil consists of soft platinum coil soldered with a stainless steel wire. The devices are further sub segmented into embolic coils, flow diversion devices and liquid embolic agents. The market was held largely by the embolic coils and is expected to at a faster pace.

Embolization coils are used to treat brain aneurysms and cardiac aneurysm and others blood related conditions. This is used as an alternative to surgery embolization to cut the supply of blood to the tumor. The market for neurovascular devices is expected to grow significantly due to the rising demand for the minimally invasive procedures. These coils are mostly made up of stainless steel in order to offer better performance post implantation. The embolization coil used for the brain aneurysm is less invasive and thus it is safer than other procedures. The companies such as Medtronic, Stryker, Terumo Corporation, Penumbra Inc. and others offers embolization coils for the cerebral aneurysm. Hence, the additional benefits offered by the coils along with its minimal invasive nature is expected to fuel the demand for the segment at a significant pace during the forecast period.