Patients treated using the Abiomed Impella RP System have recently started developing a higher mortality rate than previous rates based on past premarket clinical studies. This data is a result of the FDA evaluating a recent interim post-approval study (PAS). The use of the Impella RP System is designed to assist patients undergoing open chest surgery to maintain stable heart function.
Benefits Outweigh Risks
There is a concern at the FDA about the high mortality rate identified in the interim PAS. There is a belief by some medical professionals that the Impella RP system is best when used with patients who have been appropriately approved. In this case, the benefits presented by the device significantly outweigh its risks.
The Impella RP System was authorized for use by the FDA on September 20, 2017. It was used to help patients who need temporary emergency support of their right ventricular function. The device is implanted via peripheral access and placed centrally. Patients may be required to stay in the hospital for up to 14 days after using the device.
Strict exclusion and inclusion criteria were used in premarket clinical studies. During this time, approximately 44 of 60 patients survived. This means 73.3 percent of patients survived for 30 days after their hospital discharge. It also includes those who survived at the start of the next term of therapy. These are individuals who had the implantation of the surgical right ventricular assist device (RVAD) as well as those who had a heart transplant.
The high mortality rate seen in the PAS prompted the FDA to require additional analysis from Abiomed. Results show premarket clinical patients have usually been in cardiogenic shock for over 48 hours when the device was used. Some were treated with an intra-aortic balloon pump while others were treated using other in-hospital cardiac arrest procedures. The FDA’s evaluation is ongoing. The root cause of the high mortality rate remains unknown.
Awareness – Individuals should be aware approval of the Impella RP System by the FDA was based on findings of studies that were premarket clinical. Patients who were part of the study experienced cardiogenic shock for under 48 hours before being implanted with the device.
Consideration – When making decisions concerning ongoing treatment, the interim survival rates, as well as all the benefits and risks associated with using the Impella RP System, should be considered.
Reporting Procedures – Facilities subject to the facility reporting requirements set forth by the FDA are required to obey reporting procedures. The procedures established by these facilities must be followed by their health care employees.
Report – Any adverse events, as well as suspected events involving the Impella RP System, must be reported.
Compliance – User facilities, as well as any device manufacturer, are required to be in compliance with all Medical Device Reporting (MDR) regulations that apply.
Submitting Reports – Reports can be submitted voluntarily through MedWatch using the Adverse Event Reporting program involving FDA Safety Information.
Data from the continuing PAS will be reviewed by the FDA. It will be obtained from all available data sources. Abiomed will continue to work with the FDA to make certain the PAS interim results continue. New or additional information will be made available to the public.
It is possible for individuals to have been harmed by this medical device. Legal professionals at KBA Attorneys have experience with the FDA and medical device manufacturers. They know how to evaluate a potential case and what is the best way to proceed. Fill out our online application or contact KBA Attorneys today for a case evaluation.