- FDA set a two-day meeting Dec. 4-5 for the Circulatory System Devices Panel of the agency's Medical Devices Advisory Committee. On day one, the panel will discuss and vote on Impulse Dynamics' premarket application for a first-of-its-kind cardiac contractility modulation device to treat class III heart failure.
- On day two, the panel will make recommendations on issues related to the emergence of medical devices, now in clinical studies, that aim to treat hypertension.
- FDA seeks input on potential indications and labeling for devices to treat hypertension, study design to evaluate benefits and risks as well as appropriate study controls, issues such as medication compliance and the patient perspective.
The American Heart Association estimates the prevalence of heart failure at 6.5 million American adults, with the number of those diagnosed expected to climb 46% by 2030. Five-year mortality is 50% over five years.
Efforts to combat this major health problem have focused on multiple drug therapies and life-sustaining implants such as left ventricular assist devices and cardiac resynchronization therapy via a specialized pacemaker.
If approved, Impulse Dynamics' cardiac contractility modulation (CCM) implant would represent the first new device approach to address heart failure in the United States in more than a decade. The unit, an implantable generator that delivers electric pulses to the heart muscle, is intended for class III heart failure patients who do not respond well to medical therapy. Similar to a pacemaker or implantable cardioverter defibrillator, the device is implanted in the chest and attached to the heart via lead wires. Approved in Europe, Optimizer Smart is an advanced version of the device. More than 3,500 patients worldwide had received CCM through an Optimizer device as of last year, according to the company.
Hypertension is a major risk factor for heart failure. On the second day of FDA's December advisory panel meeting, the committee will discuss and make recommendations to address the development of medical devices to treat hypertension being studied in clinical trials.
Given the widespread prevalence of hypertension, with nearly half of U.S. adults having high blood pressure according to recently revised AHA/American College of Cardiology guidelines, it is no surprise that digital health apps focused on the condition have proliferated. Many encourage lifestyle changes by helping people track their weight, exercise and eating habits as well as their blood pressure.
For people taking medication to control their blood pressure, smartphone apps such as Medisafe provide reminder alerts. In a recent study presented at the AHA's 2018 scientific sessions, hypertension patients who used the Medisafe app were 8.3% more likely to take their blood pressure medication.