A-FLUX Reducer System®

An hourglass-shaped device that gently narrows the main vein draining the heart

The A-FLUX Reducer System® is a small, self-expanding nitinol device placed in the coronary sinus. It is currently being evaluated in the SERRA study series.

How A-FLUX® Works

The coronary microcirculation is responsible for delivering oxygen to the heart muscle. When the smaller vessels fail to function properly, the larger arteries can look normal while the muscle they supply does not get the perfusion it needs.

A-FLUX® works through the venous system instead of the arteries.

The coronary sinus is the main vein that drains blood from the heart muscle. It also contributes to the pressure environment that influences blood flow through the heart’s smaller vessels.

A-FLUX® is delivered by catheter to the coronary sinus, where the self-expanding, hourglass-shaped nitinol mesh creates a controlled narrowing. This narrowing raises pressure on the venous side, which improves perfusion through the heart’s smaller vessels and increases coronary flow reserve.

 

The Device

A-FLUX® is engineered around proprietary SwiftCell® Technology, an hourglass nitinol mesh design developed for the coronary sinus.

Self-expanding

A nitinol mesh shaped like an hourglass. It opens to fit the coronary sinus once deployed.

Repositionable

The device can be recaptured up to half deployment. The implanting physician retains control until the final position is set.

SwiftCell® Technology

A tighter mesh weave at the narrow point of the hourglass. This is where the flow modulation happens.

Four Sizes

9 mm, 11 mm, 13 mm, and 15 mm. Selected to match the patient’s coronary sinus diameter.

Self-expanding

A nitinol mesh shaped like an hourglass. It opens to fit the coronary sinus once deployed.

Repositionable

The device can be recaptured up to half deployment. The implanting physician retains control until the final position is set.

SwiftCell® Technology

A tighter mesh weave at the narrow point of the hourglass. This is where the flow modulation happens.

Four Sizes

9 mm, 11 mm, 13 mm, and 15 mm. Selected to match the patient’s coronary sinus diameter.

The Procedure

A-FLUX® is implanted in the cath lab during a minimally invasive procedure. A catheter is guided through a vein into the right side of the heart, where the coronary sinus is located. The device is then placed in the coronary sinus, where it self-expands into position.

The device can be adjusted during placement, allowing the physician to confirm the right position before completing the procedure.

Clinical Evaluation

A-FLUX® is currently being evaluated in the SERRA study series at cardiovascular centers in the United States and Europe. SERRA-I is the early feasibility study currently enrolling patients with coronary microvascular dysfunction.