Biotronik’s Next Generation ICDs and CRT-Ds Gain FDA Clearance With Home Monitoring®

In short

Less than a week ago we were reporting here that Biotronik’s Lumax 740 implantable cardioverter defibrillators (ICD) had been implanted in a first Asian patient. Now the company tells us that it has received FDA clearance for its new Lumax 740 ICDs and cardiac resynchronisation therapy devices (CRT-Ds). Biotronik’s claimed “USP” is the ability of its Lumax 740 to monitor and treat arrhythmias and heart failure under ever-changing medical conditions.

Background

Biotronik makes big claims for its device in a press release issues on Thursday May 10th. It cites three major competitive strengths, namely the high level of information definable by the system, the degree of prevention of inadvertant shock and thirdly the durability which Biotronik claims as its hallmark.

To substantiate these claims, the company helpfully provides a bit of back-up:

Information:

Thoracic Impedance is one of nine meaningful heart failure parameters transferred by Biotronik Home Monitoring®, with several parameters allowing for customisable alerts settings, which means patient’s information is automatically transmitted from the device on a daily basis and readily available to the physician without the need for any patient interaction.

Biotronik Home Monitoring® is the industry’s only remote patient management system with FDA and CE clearance for early detection of clinically relevant events.

Shock avoidance:

Lumax 740 devices are equipped with a highly sensitive and specific algorithm called SMART Detection®, which automatically extends to redetection to discriminate between true ventricular arrhythmias and supra-ventricular tachycardia.

In contrast to competitors, Biotronik’s SMART Detection® continues to fully function even after a first therapy attempt, which allows the device to provide pain-free therapies without compromising specificity. The ability to differentiate atrial from ventricular arrhythmias with high specificity reduces the risk for painful inappropriate shocks.

Durability:

Biotronik says its new device platform includes more efficient circuitry that extends device longevity by up to 15 months, providing nearly a decade of service. A new platform lessens manufacturing complexity and according to the company assures “consistently outstanding product quality” and builds on its reputation for reliability.

Source: Biotronik