- St. Jude Medical’s HeartMate 3 left ventricular assist system outperformed its predecessor, HeartMate II, in patients with advanced heart failure, according to initial data from a large clinical study, Reuters reported.
- Out of the 294 patients who participated in the company's trial, 86% survived without a disabling stroke or a need for a reoperation to repair or replace HeartMate 3 six months after implantation, compared with 77% who received the older device.
- HeartMate 3 is designed to prevent pump thrombosis — a complication where blood clogs up the device, requiring replacement surgery.
HeartMate 3 met its primary endpoint of noninferiority and superiority to its forerunner, HeartMate II. The devices had similar stroke and survival rates, and HeartMate 3 was free of pump thrombosis. There were 18 incidents of the problem in the older device.
St. Jude acquired Thoratec in 2015, gaining HeartMate II and 3, as well as the HeartMate PHP percutaneous heart pump and a range of complementary products.
The new data is a spot of good news in an otherwise dreary news cycle for St. Jude this fall. The company sued Muddy Waters Capital and cybersecurity firm MedSec for publicly reporting that its cardiac devices are vulnerable to hacking and short selling the company’s stock.
Outside security experts corroborated Muddy Waters and MedSec’s claims in a brief filed by the two firms in federal court. The brief was followed by St. Jude initiating a Class I recall and corrective action plan, involving a total of 13 different devices and 39 models, related to “rapid battery failure.”