CircuLite®, Inc. has today announced receipt of conditional approval from the U.S. FDA of an Investigational Device Exemption (IDE) for its lead product, the SYNERGY® Circulatory Support System. Synergy is a minimally-invasive device designed to reverse the symptoms of heart failure in ambulatory chronic heart failure patients.
We covered the Synergy product last September when CircuLite announced it had gained CE mark approval for the device. That coverage, which you can find here, tells you a little more about the device. In essence, it is the world’s smallest circulatory support pump and is designed to work in synergy with the native heart to improve blood flow to the brain and body, rather than replace the heart’s function.
The implantation procedure is minimally invasive and does not require open heart surgery, eliminating the need for cardiopulmonary bypass. It is performed through a mini-thoracotomy and the micro-pump is implanted in a shallow “pacemaker pocket”. It enables a quick recovery, offering the potential to impact the economics of treating ambulatory chronic heart failure patients.
In the European study used for CE Mark approval, Synergy was shown to improve hemodynamics, exercise capacity and overall quality of life in ambulatory chronic heart failure patients (INTERMACS ≥4 or NYHA Class III/IV).
With the newly announced conditional IDE approval, CircuLite plans to commence its U.S. clinical trial evaluating the use of the Synergy Circulatory Support System for long-term support in ambulatory chronic heart failure patients (INTERMACS ≥4) who remain symptomatic despite optimal medical management. The IMPACT Trial (Safety EvaluatIon of the CircuLite SYNERGY Circulatory Assist Device in a Non-Inotrope Dependent, AMbulatory Patient with End-StAge Chronic Heart Failure: A PiloT Study) is a 20-patient feasibility trial that will be conducted at seven U.S. clinical sites.
“Many ambulatory chronic heart failure patients have a very poor quality of life today,” said Daniel Burkhoff, MD, PhD, Chief Medical Officer of CircuLite and Adjunct Associate Professor of Medicine at Columbia University Medical School. “Despite running the gamut of heart failure treatment, they are severely restricted by their symptoms, yet are not sick enough to justify more invasive surgical treatment options. SYNERGY has the potential to reverse many of the abnormalities that underlie those symptoms, with the goal of improving a patient’s activity level and quality of life.”
“Beginning our U.S. feasibility trial marks a significant milestone for the company, and is the first step on our path to providing a new treatment option to tens of thousands of U.S. ambulatory chronic heart failure patients who have no other options today,” said Paul Southworth, Chief Executive Officer of CircuLite.
Following its CE Mark in September 2012 CircuLite is currently performing a controlled commercial roll-out of the Synergy device in Europe.
In the United States it is now considered an Investigational Device and as such is limited by law to Investigational Use Only.
CircuLite® and SYNERGY® are registered trademarks of CircuLite, Inc. in the United States.
Source: CircuLite, Inc.