Devices

Impella Heart Pump Study Confirms Survival Data

Abiomed says that a post-approval study confirmed survival data in its pre-approval study for the Impella RP heart pump. “Nearly two years of real-world outcomes data on Abiomed’s Impella RP heart pump shows that when physicians followed the FDA’s approved protocol for Impella RP use they achieved 72% patient survival and 88% native heart recovery,” the company says. The protocol includes recommendations on patient selection and timely identification of right heart failure with subsequent implantation of Impella RP. The new data was presented 10/25 at a clinical meeting in Detroit on managing patients in cardiogenic shock.

In May, FDA issued a revised safety update on the device that emphasized proper patient selection after interim post-approval study (PAS) results indicated a lower survival rate for the subgroup of PAS patients who would not have qualified for inclusion in clinical studies performed before the device was approved. The Impella RP System is a temporary right heart pump system intended to help patients maintain stable heart function without open chest surgery. “Based on our current analysis, the FDA believes 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,” the update said.

“Interim results from the most recent Impella RP System PAS report indicate that 12 out of the 42 enrolled PAS patients (28.6%) survived to 30 days post device explant or hospital discharge, or to the start of next longer term therapy,” the agency wrote. “In the premarket clinical studies, the survival rate was 73.3%.” The primary reason for different survival outcome appeared to be patient selection, FDA said. “For the subgroup of PAS patients who would have met the enrollment criteria for the premarket clinical studies, the survival rate was 64.3% (9 out of 14 patients) which is similar to the premarket clinical study survival rate,” it said. “For the subgroup of PAS patients who would not have qualified for the premarket clinical studies, the survival rate was 10.7% (3 out of 28 patients). In these patients, the PAS survival rate should be interpreted in the context of the patients' conditions and limited treatment options.”

FDA recommended that health care providers read and follow the revised labeling for Abiomed’s Impella RP System, which includes a patient selection checklist to understand which patients may benefit the most from treatment with the Impella RP System.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

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