Belgian researchers are rebuffing transcatheter aortic valve implantation (TAVI) technology--made by Edwards Lifesciences ($EW), Medtronic ($MDT) and others--with a new assessment that concludes solid evidence may not back their now-widespread international use. Details are published in the British Medical Journal. MedPage Today and MassDevice, among others, offer a good summary of the research analysis.
The researchers argue that TAVI reimbursement only be given to patients determined to be inoperable for technical reasons, such as when previous operations or chest wall irradiation makes them inoperable. About 10% of patients are considered for TAVI tech, according to the MedPage Today story.
They particularly target Europe's regulatory approval process for devices, which, as the MPT article notes, placed Medtronic's CoreValve and Edwards' Sapien on the market internationally in 2007. Why is this an issue? They are critical of the approval before substantial clinical evidence was available for consideration. CoreValve hasn't been approved yet in the U.S. Particularly, they also challenge the idea that TAVI is suitable for patients who could also benefit from surgery, considering that the stroke risk is much higher for TAVI procedures and the product also costs much more than traditional surgical valve replacement.
That's a particular smack against Edwards' Sapien product, which just launched in the U.S. earlier in 2012 and gained the all-important approval for Medicare reimbursement. The company also won a crucial nod from an FDA panel of experts in June that recommended Sapien be approved for use in a broader class of patients, adding on patients with severe aortic stenosis who are high-risk but could also turn to surgery as an option. Sapien relied on data from the pivotal PARTNER trial, which showed a death rate similar for surgery or TAVI, but noted the rate of stroke for the procedure doubled 30 days after its use.
Panel members decided the stroke risk didn't diminish TAVI's benefits, but the Belgian researchers knocked the PARTNER trial as having publication bias, a lack of data transparency, unbalanced patient characteristics and conflicts of interest that weren't mentioned, MassDevice reports.
- read the MedPage Today story
- consider MassDevice's take