Untested Use of Cardiac Surgery Device Lariat Proves Dangerous
Posted by Rob Jenner on Jul 15, 2015 in Medical Malpractice
A Class II medical device called Lariat® (SentraHEART, Inc.) fails one out of 10 times when used “off label” in a cardiac procedure to clamp off a potential source of dangerous blood clots in high risk heart patients. Furthermore, using Lariat in this procedure often leads to urgent cardiac surgery or death and does not lower the risk of stroke in patients who undergo the procedure. Those are the startling findings published by researchers recently in JAMA Internal Medicine.
A look at the history of the device and the company behind it also shows Lariat was fast-tracked for approval by the FDA based on questionable information.
Maker Claims Lariat Can Lower Stroke Risk
Lariat is a magnet-controlled snare-like device that cardiac surgeons have been using since about 2006 in a non-FDA approved use to clamp off the left atrial appendage in the hearts of patients with fibrillation and clotting issues. This appendage, an ear-shaped muscle tucked into the upper corner of the left atrium, can harbor blood clots, formed by pooling blood, in patients with erratic blood flow. The concept is that closing this appendage prevents clots from entering the bloodstream and causing a stroke. SentreHEART claimed Lariat could make the clamping easier, less risky and thus lower a patient’s stroke risk.
But SentreHEART didn’t have actual proof of those claims.
Lariat Fails One-in-Ten and Doesn’t Lower Stroke Risk
For the JAMA report, researchers from several U.S. institutions, led by Dr. Jay Giri, (Perelman School of Medicine at the University of Pennsylvania, Philadelphia), began analyzing what little data was available about Lariat outcomes: five published case studies (not clinical trials) that enrolled just 309 patients, and the FDA’s medical device adverse events database. The case studies showed the Lariat procedure was unsuccessful in about one in 10 patients and often led to the need for urgent cardiac surgery or death. The FDA’s database yielded an additional 35 adverse events, including 23 cases of urgent cardiac surgery.
And the kicker? According to the data, there was no evidence that use of Lariat lowered stroke rates.
SentreHEART’s Bait and Switch On FDA’s Approval
Lariat’s manufacturer, SentreHEART, obtained FDA approval for Lariat through a fast-track process (the agency’s (510)k application process) – a shortcut that allows devices that are “substantially similar” to already approved devices to forego rigorous testing and be fast-tracked. SentreHEART’s application described Lariat as a “suture device,” but made no mention of its use in cardiac surgery. Since other suture devices had been approved, the FDA in 2006 approved Lariat for use as a suture device.
Then an interesting thing happened. The company immediately applied for a patent on Lariat as a device for use in left atrial appendage (LAA) cardiac surgery. Next, it launched a heavy marketing campaign (complete with cowboys swinging ropes) promoting this unapproved use of the Lariat device to cardiac surgeons.
Lariat Report An Embarrassment to Medicine
The Lariat report no doubt was a major embarrassment to the medical community. Although cardiology leaders have been quick since its publication to urge caution in the use of Lariat, and have urged SentreHEART to engage in clinical trials, it is obvious doctors failed to ask the most basic of questions about the device when it came on the market. Namely, what proof did the company have that the benefits of the procedure outweighed its risks? And was there evidence that it actually lowered the patient’s risk of stroke?
Turns out the answer to those questions was “none” and “no.”
Lawsuit Cheaper Than Losing Profits
It’s not the first time the FDA and doctors have been suckered by certain drug and medical device makers. The ploy seems to be: get into the market quick, make a killing profit-wise, and get out when you’re forced to by evidence of harm. As corporate-think goes: it’s cheaper to pay out in lawsuit settlements and verdicts than it is to pull a product prematurely. I deal with this kind of thinking regularly in my work as a dangerous drug and medical device lawyer.
The whole Lariat mess stinks and erodes trust in medicine as a whole. Doctors should always ask hard questions of any product being promoted for an off-label use.