MitraClip passes FDA hurdle | theheart.org
Mitraclip is a device that can be used to treat a leaking mitral valve, which is one of the valves in the heart.. The main advantage of this device is that it can be inserted percutaneously without the need for open surgery. The gold standard treatment for mitral regurgitation is surgery. However not all patients are suitable or fit for open surgery. Mitral regurgitation is also an epiphenomenon of heart failure and when present is associated with repeated need for hospitalisation. This type of mitral regurgitation is very rarely dealt with surgically. Use of the mitraclip therefore has the potential to decrease many admissions to hospital due to heart failure. More than 4000 of these devices have been inserted into patients in Europe since 2008 when the CE mark was awarded. The American FDA, who traditionally are very conservative when it comes to approving devices has finally given a stamp of approval through one of its expert advisory panels. These panels consist of cardiologists and cardiac surgeons who are recognised experts in the field of mitral valve disease and related heart failure. The proceedings of these panels are open and transparent.
In the UK, there is no equivalent of the FDA. Devices are approved as being safe with a CE mark granted by the European Union. There is no requirement for them to be effective. As one can imagine, the bar for CE marking is set pretty low. Mitraclip has had a CE mark for several years. The NHS commissioning board or as it is now known NHS England are responsible for commissioning of specialised procedures and devices. In recent weeks it has published guidelines on the commissioning of specialised procedures. It has decided that the NHS will not routinely commission Mitraclip. It will however 'Commission through Evaluation". This process is described on NHS England's website - ‘Commissioning through Evaluation’ enables treatments or procedures to be commissioned initially on a limited basis whilst further evaluation is carried out to determine whether a substantive commissioning policy should be developed for future use'.
I am not sure that this position NHS England have decided to adopt is logical. It certainly is vague. There is no doubt that the Mitraclip reduces mitral regurgitation in a safe fashion and there is no doubt that it does so in a less traumatic & less invasive fashion when compared to surgery. That surely is the only evidence one requires before commissioning. The decision as to whether the patient is treated percutaneously, surgically or medically should be taken by the patient's physician or Heart Team. It is this decision that will be determined by emerging evidence.