Devices

FDA Confirms Survival Rate With Abiomed’s Heart Device

FDA says final results from a required post-approval study (PAS) on Abiomed’s Impella RP System confirmed the survival rate seen in premarket data, adding that the device is safe and effective when used for the currently approved indication. The device was approved in 2017, and in 2019 FDA raised red flags after interim PAS results suggested a higher mortality rate than was previously observed in premarket clinical studies. The temporary right heart pump system is intended to help patients maintain stable heart function without open chest surgery. “Although the FDA is concerned about the high mortality rate from the interim PAS results, we believe that when the device is used for the currently approved indication in appropriately selected patients, the benefits of the Impella RP system continue to outweigh the risks,” a device safety alert said at the time.

Data from the recent final PAS results have been incorporated into updated labeling for the device, including an update to the indications for use statement to “better reflect the characteristics of the patients who may benefit the most from treatment with the device,” an updated FDA notice says. The agency also provided this “high level summary” of the final results for the primary endpoint:

For the subgroup of PAS patients who would have met the enrollment criteria for the premarket clinical studies, 23 out of 33 evaluable patients (69.7%) survived to 30 days after device explant or hospital discharge (whichever was longer), or to the start of next longer-term therapy. This survival rate is consistent with the premarket clinical studies survival rate.
For the subgroup of PAS patients who would not have qualified for the premarket clinical studies, the corresponding survival rate was 18.6% (13 out of 70 evaluable patients). In these patients, the PAS survival rate should be interpreted in the context of the patients' conditions and limited treatment options.

Additionally, FDA notes that PAS patients who would not have qualified for the premarket clinical studies “were more likely to have been in acute right heart failure or decompensation for longer than 48 hours and experienced a severe cardiogenic shock, end organ failure, or acute neurologic injury, compared to the PAS patients who would have met the enrollment criteria for the premarket clinical studies.”

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome