INNOVATION PARTNER PROFILE/SISK HEALTHCARE:Sisk healthcare has announced a revolutionary medical device which will dramatically improve the lives of patients with heart problems
AN INNOVATIVE NEW medical device just introduced to Ireland by Sisk Healthcare company Tekno Surgical could lead to dramatic improvements in the treatment outcomes for a significant proportion of patients suffering from heart failure and require Cardiac Resynchronisation Therapy (CRT).
CRT is a therapy that delivers timed electrical pulses to the chambers of the heart. This allows the heart to beat in a more co-ordinated and synchronised manner, thus more effectively.
Studies have shown that around one-third of patients with advanced heart failure do not effectively respond to cardiac resynchronisation therapy (CRT). In order to improve therapy success rates, it is important to offer each patient a tailor-made programming of the timing between electrical impulses sent to different parts of the heart (CRT settings) on a regular basis.
Developed by international medical device company Sorin Group, the new SonR device is the only self-adjusting Cardiac Resynchronisation Therapy (CRT) optimisation system which meets this need by providing optimised timing at rest and exercise for improved response. Sorin Group is a global medical device company and a leader in the treatment of cardiovascular diseases. The company develops, manufactures and markets medical technologies for cardiac surgery and for the treatment of cardiac rhythm disorders.
“We have been working with Sorin for a number of years and have a very strong relationship with them,” says Michael Connole, managing director of Sisk Healthcare company Tekno Surgical. “The company’s success is built around its cardiovascular products and related therapeutic services. It is has firmly established itself as a market leader in the area of cardiovascular device technology.”
Current optimisation methods include echocardiography and other device-based timing features. Echocardiography is difficult and time-consuming while other device-based CRT optimisation features have shown limited benefits. All of these current methods require manual steps. They are typically performed only once and only while the patient is resting.
SonR is the only CRT optimisation system that automatically optimises patients every week and, importantly, while the patient is active, providing real-life optimisation. This is far preferable to in-clinic manual echocardiography-based device optimisation for improved CRT response. Promising early clinical results suggest that SonR increases responder rates and reduces heart failure hospitalisations compared with standard medical practice over a one-year follow-up.
The result of a 10-year clinical science program, the SonR sensor uniquely measures patient’s cardiac muscle vibrations. These real-time measurements are transmitted to the CRT-D device which uses them to determine the best settings for the patient. Every week, the system automatically optimises to adapt to the patient’s changing condition. SonR measurements correspond to LVdP/dtmax, the gold standard for assessing left ventricular (LV) contractility, a key indicator of cardiac performance.
“The treatment of patients with heart failure is a major healthcare expense with repeated hospital admissions representing almost 80 per cent of a patient’s lifetime medical costs,” says consultant cardiologist Dr Thomas Gumbrielle. “In one-third of such patients, electrocardiograms (ECGs) demonstrate delays in the electrical stimulation of heart muscle which result in impaired contraction known as dyssynchrony. A specialised form of pacemaker therapy known as cardiac resynchronisation therapy (CRT) restores synchrony, improves outcomes and reduces readmissions by up to 70 per cent.
“However, not all patients respond to CRT, possibly due to subtle imbalances in the timing of pacemaker impulses to heart muscle, and this is a major topic of clinical research. New technology in the Sorin SonR pacemaker uses a novel cardiac sensor of heart sounds to optimise pacemaker timing at rest and during exercise. The SonR can also be programmed to automatically adjust pacing between different chambers of the heart on a weekly basis. This exciting new tool is in the early stages of development but has already been shown to result in an improvement of up to 20 per cent in responders to CRT pacing.”
Phillipe Ritter of the University Hospital in Bordeaux believes that the conformance of the SonR signal with measurements of LVdP/dtmax suggests that the new device is a reliable means of tailored optimisation of CRT devices. “Providing weekly optimisation both at rest and exercise is a significant step forward in the treatment of heart failure patients,” he says.
“We are delighted to be the first to make the SonR device available to Irish cardiac patients,” says Michael Connole. “It has tremendous potential to improve treatment outcomes and this is reflected by the reception it has received from the medical community. It has come to market after being evaluated and tested over a number of years and it really is quite exciting.”
He points to the time-saving aspect of the device as being among its most important qualities. “It has great safety technology built in and will save greatly on time for both patients and the health service,” he says. “Because it is monitoring the patient in real time and adjusting the device once a week as a result, there is no need to bring the patient into the clinic for tests and modifications. This will improve comfort and convenience levels for patients and will generate significant savings for the health service.”
“The SonR system is the result of Sorin Group’s tradition of excellence in innovation,” says Stefano Di Lullo, president of the Sorin Group CRM Business Unit. “We are proud to bring this technological breakthrough to market. The introduction of this new CRT system provides new horizons in heart failure treatment options and is a reflection of our commitment to innovation in the hemodynamic management of heart failure patients.”
