The FDA approved Medtronic's
Pipeline Flex, a flow diversion device used to treat large and giant
wide-necked brain aneurysms. According
to the company, the device can treat brain aneurysms that are not amenable to
treatment with surgical clipping and are attached to parent vessels measuring
between 2.5 and 5.0 mm in diameter.
"Flow diversion has been a major breakthrough therapy for
large or giant wide-necked brain aneurysms that are complex and have
considerably higher risk of rupture and higher rates of complication with
conventional treatment.
Clinical Trials - Different Phases of the trial
Clinical trials serve as a vital component for improving the treatment of medical conditions as they lead to higher standards of patient care.
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With thousands of patients successfully treated with Pipeline Embolization Device, the Pipeline Flex's innovative delivery system will result in further advancing endovascular treatment and care," said Dr. Ricardo Hanel, Neurosurgeon, Director of stroke and Cerebrovascular Center at Baptist Health in Jacksonville, Florida.
Designed to divert blood flow away from an aneurysm, the device
features a braided cylindrical mesh tube that is implanted across the base or
neck of the aneurysm. The device cuts off blood flow to the aneurysm,
reconstructing the diseased section of the parent vessel.
![FDA Approves Melody Transcatheter Pulmonary Valve to Treat Congenital Heart Disease Patients]( "FDA Approves Melody Transcatheter Pulmonary Valve to Treat Congenital Heart Disease Patients")
Medtronic said that it won pre-market approval from the FDA for its Melody transcatheter pulmonary valve.
"This device is the next advancement in flow diversion, combining our clinically-proven braid design2 with a new delivery system designed to offer improved accuracy and control when performing these advanced procedures inside the brain. We are excited to bring new value to our medical community," said Brett Wall, president, Neurovascular, Medtronic.
Source: Medindia
FDA Approves Melody Transcatheter Pulmonary Valve to Treat Congenital Heart Disease Patients
Medtronic said that it won pre-market approval from the FDA for its Melody transcatheter pulmonary valve.
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"This device is the next advancement in flow diversion, combining our clinically-proven braid design2 with a new delivery system designed to offer improved accuracy and control when performing these advanced procedures inside the brain. We are excited to bring new value to our medical community," said Brett Wall, president, Neurovascular, Medtronic.
Source: Medindia
Suction Cervical Retractor Gets FDA Approval
The device can be used to perform intrauterine device insertions, endometrial biopsies, as various fertility procedures.
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 Generic Version of Nexium Approved by FDAGeneric drug makers are racing to win FDA approval for selling their heartburn drugs on the market. | Advertisement
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