Cambridge, MA and UK– November 14, 2011 – Cambridge
Consultants, a leading technology design and development firm, today unveiled how
it has collaborated with start-up company EBR Systems to develop the worlds
first wireless pacing system. With cardiac stimulation leads considered the
weak point in pacemaker systems, the Wireless Cardiac Stimulation system (WiCS)
uses a leadless electrode to convert mechanical energy, wirelessly transmitted
from an ultrasonic pulse generator, into electrical energy which is used to
pace the heart as part of Cardiac Resynchronization Therapy (CRT).
Eliminating the lead in the left side of the heart presents
a major breakthrough in pacemaker design, and brings new hope for over 2.2
million advanced heart failure patients worldwide, who can benefit from CRT
therapy. It also provides a life-saving option for those patients who do not
benefit from CRT therapy, either because of the complexity of the procedure, or
the limitations of the current technology.
WiCS is the first leadless system to be successfully
implanted in early human clinical trials at leading centers in Europe. This platform technology will ultimately
eliminate all pacing leads and deliver superior cardiac pacing therapy through
its flexibility in where the electrode can be placed.
Current CRT pacemakers or defibrillators are implanted in
patients with chronic heart failure requiring both the left and right
ventricles to be paced. Such devices require the implantation of three leads
into the heart, one of which involves painstakingly threading a lead through a
difficult and complex route running from the right atrium of the heart, out of
the heart and into the coronary sinus, a vasculature structure on the outside
surface of the heart to the left ventricle. A pacemaker/defibrillator device is
connected to the leads which are used to sense heart activity and to deliver
electrical stimulation through electrodes at the end of the leads. The
electrical stimulation applied to the right and to the left ventricles
synchronizes the hearts contraction in a way that improves overall cardiac
function in heart failure patients. However, added to the difficulty of the
procedure itself is the chance of lead failure and infection.
WiCS overcomes these problems by leveraging advances in
energy harvesting microelectronics. A very small leadless electrode, is
implanted in the desired location within the left side of the heart. In its
first generation, WiCS works in conjunction with a conventional
pacemaker/defibrillator, sensing the electrical pacing pulse of the pacemaker
from the right ventricle. The pulse generator then transmits an ultrasonic pulse
to the implanted receiver, which converts the sonic energy into electrical
energy to pace the left ventricle in synchronicity with the right. Not only
does this reduce the need for the difficult and complicated surgery associated
with CRT pacemakers, but by pacing inside the left ventricle it also better
mimics the natural activation and mechanical contraction pattern of the heart.
With hospital resources already stretched, the leadless
system significantly reduces the time taken to carry out the complicated
procedure which requires threading the lead through the coronary sinus vein to
the left ventricle of the heart. The WiCS procedure is simple and predictable,
resulting in streamlined scheduling of operating theaters and cost savings.
The innovative technology was developed in conjunction with
leading design and development firm Cambridge Consultants. Using its deep
knowledge of integrated circuit (IC) design, Cambridge Consultants helped EBR
define the system architecture which could be realized with modern silicon chip
technology. Power consumption, size and safety are critical in pacemaker
applications, and the team at Cambridge Consultants developed advanced
low-power circuits to interface with the ultrasonic transducers and heart
monitoring sensors. With reliability critical, coupled with the need for
sophisticated signal processing, Cambridge Consultants created two
state-of-the-art mixed-signal Application-Specific Integrated Circuits managed
by its powerful XAP4 processor to form the core of the WiCS pacing system.
During the development, Cambridge Consultants created a full system hardware
emulator of the final ASIC so that the other system elements and the software
could be designed and fully tested over a year before prototype ASICs were
available. This approach dramatically reduced the overall time of the
development and enabled EBR to ensure that the system would work as envisaged
before committing to the costly and time-consuming manufacture of final
product.
Allan Will, CEO of EBR Systems, commented, “The WiCS system
represents a huge breakthrough in pacemaker technology, not only in how we
treat chronic heart failure patients today, but in eliminating leads and
enabling site selected pacing locations in the heart for a wide variety of
cardiac pacing applications. Many of the complications and reliability failures
of pacemaker systems are attributed to leads. By eliminating leads, we can
address the problems which come with them, and advance cardiac pacing therapy
for all patients.”
“We are pleased to be
able to contribute to such an important breakthrough in medical technology,”
said Andrew Diston, Head of Global Medical Technology at Cambridge Consultants.
“We have a long history of championing cutting edge technology, and enabling
start-ups to bring their groundbreaking concepts to market. We look forward to
following this potentially lifesaving technology as it revolutionizes the
market.”
About EBR Systems
EBRs wireless pacing technology (WiCS) was developed to eliminate cardiac
pacing leads, historically an impediment to efficacy and major source of
complications and reliability issues. The initial product application addresses
an important underserved need in the heart failure population. EBRs WiCS
technology provides an elegant solution for many heart failure patients
indicated for CRT therapy including patients implanted with an existing
pacemaker or defibrillator who would benefit from upgrading their therapy,
patients denied therapy with failed attempts to implant a CS lead, patients
with chronically failed CS leads and the 30% of patients annually classified as
non- or marginal responders. Ultimately, EBRs wireless pacing technology has
the potential to replace all cardiac pacing leads, in bradycardia and heart
failure therapy.
About Cambridge
Consultants
Cambridge Consultants develops breakthrough products, creates and licenses
intellectual property, and provides business consultancy in technology critical
issues for clients worldwide. For 50 years, the company has been helping its
clients turn business opportunities into commercial successes, whether they are
launching first-to-market products, entering new markets or expanding existing
markets through the introduction of new technologies. With a team of over 300
engineers, designers, scientists and consultants, in offices in Cambridge (UK)
and Boston (USA), Cambridge Consultants offers solutions across a diverse range
of industries including medical technology, industrial and consumer products,
transport, energy, cleantech and wireless communications. For more information
visit: www.cambridgeconsultants.com.
Cambridge Consultants is part of Altran, the European leader
in innovation and high technology consulting. The Groups 17,500 consultants,
operating worldwide, cover the entire range of engineering specialties,
including electronics, information technology, quality and organization. Altran
offers its clients ongoing support throughout the innovation cycle, from
technology watch, applied basic research and management consulting to
industrial systems engineering and information systems. The Group provides
services to most industries, including the automotive, aeronautics, space, life
sciences and telecommunications sectors. Founded in 1982, Altran operates in 20
priority countries. In 2010, it generated a turnover of €1,430 million. For
more information visit: www.altran.com.