FDA Gives Green Signal to Medtronic’s CoreValve for Use in More Patients

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.


AustrianTribune Specials

Scientists at American space agency, NASA have said that the newcarbon dioxide tracking satellite is now operational.

The new mission, which will cost $468 million, is aimed at studying in driver of climate change emitted from smokestacks...

Most Popular

German specialists say they have treated a Motorhead fan...

A new study has doubted the existence of two of the...

The possibility of landing a human on Mars is one step...

Three month old Joanne, the youngest gorilla at the San...

Automotive News

  • Honda’s US regional recall due to airbag issue expanded to include California
  • Takata could face $500-million US charge and 2014 net loss due to massive airbag recall
  • Government says there is no need to park GM cars affected by ignition-switch recall
  • Mark Fields to replace Ford CEO Alan Mulally with effect from July 1

UK News

  • Mystery of Tangled Earphones solved
  • Demands to Deal with Highest Levels of Toxic Pollutants in Oxford Street
  • Study Finds Reason Why People on Psychedelic Drugs Feel their Mind is Expanding
  • BBC's Panorama Lost Highly Secretive Files of the British Army
  • BT Apologizes to Customers for Internet Connection Problems