CircuLite receives conditional FDA approval for IDE trial


CircuLite has announced that it has received conditional approval from the FDA for an investigational device exemption (IDE) study for its Synergy circulatory support system, which is a minimally-invasive device designed to reverse the symptoms of heart failure in ambulatory chronic heart failure patients.

According to a company press release, Synergy is the world’s smallest circulatory support pump and is approximately the size and weight of an AA battery. It 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 procedure is minimally invasive and does not require open heart surgery, eliminating the need for cardiopulmonary bypass. In a European CE mark clinical study, Synergy was shown to improve haemodynamics, exercise capacity and overall quality of life in ambulatory chronic heart failure patients.

“Many ambulatory chronic heart failure patients have a very poor quality of life today,” said Daniel Burkhoff, 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.”

With receipt of conditional IDE approval, the press release reported, CircuLite plans to commence its US 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 US clinical sites.

“Beginning our US 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 US ambulatory chronic heart failure patients who have no other options today,” said Paul Southworth, chief executive officer of CircuLite.

The minimally-invasive Synergy procedure is performed through a mini-thoracotomy and the micro-pump is implanted in a shallow “pacemaker pocket.” It requires no bypass and enables a quick recovery, offering the potential to impact the economics of treating ambulatory chronic heart failure patients.

The device received CE mark in September 2012 and is currently conducting a controlled commercial rollout in Europe.