Medtronic's Artificial Pancreas Pump System Wins UK Approval
Tuesday, March 31, 2015
Source: FDA News
Medtronic pump system MiniMed 640G system, designed to imitate the pancreas, has gained UK National Health Service approval. The device prevents severe hypoglycemic attacks in type 1 diabetics by detecting lowered blood sugar levels and then halting insulin production, stopping four out of five attacks, experts said.
The MiniMed is an important step toward the development of an artificial pancreas, with the potential ability to protect repeated attack sufferers, doctors added.
Manufacturers noted that the device would be of special importance to the 5 percent to 10 percent of patients whose blood sugar falls frequently without advance warning. Lowered blood sugar can cause seizures, diabetic comas and death.
The system will save people from severe hypoglycemia without them necessarily realizing they were in danger, said Dr. Peter Hammond, consultant diabetologist, Harrogate District Hospital. This is especially important given that many attacks occur at night when type I sufferers are sleeping.
Until larger clinical trials have taken place, UK rationing bodies are not expected to implement routine funding. However, individual cases are permitted to apply to the NHS for funding. The MiniMed will be available to private UK patients for an annual approximate cost of $10,000.
The MiniMed 640G’s global launch began January. A similar device, the MiniMed 530G, received FDA 510(k) clearance September 2013.
In the UK, an estimated 400,000 suffer from type I diabetes.