Calling it a big win for Medtronic Inc., the FDA has allowed its artificial heart valve to be used in more patients. The move is expected to give an edge in the medicine market.
In January, the product called CoreValve got green signal from the FDA. The product was approved for usage in patients facing 'extreme risk' of death if they underwent open-heart surgery. Doctors can use CoreValve in patients at 'high risk' of death through surgery.
The Food and Drug Administration gave the approval without requiring an advisory panel review. In March, researchers published a review revealing that 86% of the patients at high risk who received the CoreValve implants survived one year later in comparison to 81% of patients who received a new value through open-heart surgery.
In fact, the post-surgery risk was also low and blood circulation was better in the group that received the CoreValve implant. John Liddi-coat, President of Medtronic's structural heart business, said US heart teams are quite excited to know about the recent approval.
Around 550,000 people across the globe receive a diagnosis of severe aortic stenosis. Out of them, around 100,000 are Americans and about 35,000 are designated at high risk of death from open heart surgery. Around 50% of the people who get diagnosed with the condition die within two years of the diagnosis.
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