FDA updates warning on SynCardia drivers

SynCardia Systems today released an update on issues with its Temporary Total Artificial Heart’s Companion 2 driver system and released information on neurological adverse event issues with its pneumatic Freedom driver system.

A post-approval study in June 2015 indicated a higher mortality rate for a subgroup of patients using SynCardia’s TAH-t C2 driver system compared with its previous generation driver, the Circulatory Support System Console.

Updated results from a comparison of mortality rates between patients with the CSS Console and C2 Driver System indicated a continued higher mortality rate for patients requiring pre-implant circulatory rescue interventions. Mortality rates between the 2 driver systems were similar for patients outside the subgroup.

For patients who received pre-implant circulatory interventions, those on the C2 driver had a 39% mortality rate, 14% higher than those on the CSS Console. Patients on the C2 driver outside the subgroup exhibited a 27% mortality rate, only 6% higher than those on the CSS console.

The company also reported that patients treated with the C2 driver exhibited a 15% higher rate of neurological adverse events, at 31% compared to 16% for patients on the CSS Console.

SynCardia warned that the results were not adjusted for potential confounds, and were not stratified by pre-implant circulatory rescue intervention status.

“The Neurological AE rate will continue to be monitored, and additional analyses will be performed as appropriate in the future,” SynCardia wrote in its update. The company said it did not know the root cause for the observed differences, and that its “existing data is limited.”

The company also released data on a 3rd driver, the Freedom pneumatic driver system, which is also available for use with the TAH-t. The Freedom Driver is portable and usable outside of the hospital.

SynCardia said it is ‘aware of recent reports of serious, life-threatening TAH-t device malfunctions” involving the Freedom Driver system, including sudden cessation of TAH-t pumping without warning alarms or signs of an impending malfunction.

The Freedom Driver system was the subject of a Class 1 recall initiated last year, SynCardia said, and added that it is working with the FDA to assess malfunction reports.

The FDA issued its own instructions, advising instructors to carefully consider the mortality and neurological adverse events reports when making treatment decisions and device selections. The agency also advised patients and practitioners to report any adverse events or suspected adverse events with the devices, and to return any that they suspect are associated with such events.

In September, SynCardia released info on the Class 1 recall of its total artificial heart devices, citing a single incident in which a patient lost consciousness but suffered no permanent injury. All devices affected by the recall were taken off the market within 8 days after the company’s initial warning on August 6.

Earlier in September, the FDA slapped the action with Class I status, denoting an issue that could result in serious injury or death. The problem involved the SynCardia device’s Freedom driver, which is attached to the heart pump and operates and monitors the device. A specific part of the Freedom Driver mechanism may fail and cause the device to stop pumping; patients with driver failures do not receive any advanced warning of the failure, only a red light and loud continuous alarm that sound after the failure.

In the same month, SynCardia said that it was acquired by affiliates of investment firm Versa Capital Management, with current president & CEO Michael Garippa set to keep the corner office.

Tuscon-based SynCardia makes an artificial heart system designed to replace the functions of both the left and right ventricles and all 4 heart valves.

On August 16, SynCardia announced it would emerge from Chapter 11 reorganization with a new owner, Sindex, while rebuking claims from a french competitor Carmat (FRA:CXT) that it was exiting the market.