MEDICAL DEVICE INNOVATION - Medical Device Daily

MEDICAL DEVICE INNOVATION 2010
Cameron in CE mark testing of
subcutaneous, ICD leadless tech
By OMAR FORD
Medical Device Daily Staff Writer
To say that there are issues concerning the safety of
implantable cardioverter defibrillator devices would be an
understatement.
A massive recall of the Sprint Fidelis lead made by
Medtronic (Minneapolis) helped solidify a variety of questions
related to their use in the company’s ICDs, after five
people implanted with the Fidelis ICD leads died because of
fracturing, a problem found to be much more frequent than
the expected risk parameters. The leads were eventually
pulled from the market, with class action lawsuits lined up
against the company as a consequence.
And more recently, two cardiologists, Dr. Robert Hauser
and Dr. Adrian Almquest, in the New England Journal of
Medicine, have raised questions concerning the bench-testing
proposed for a new type of significantly thinner defibrillator
lead, which would require four lead placements in
the heart, being developed by major cardio firms.
And, in any case, whatever type of ICD lead is used, the
requirement is for insertion in or near the heart.
As an advanced technical response to these issues, two
electrophysiologists, Gust Bardy, MD, and Riccardo
Cappato, MD, have founded Cameron Health (San
Clemente, California) to develop a device that they offer as
providing all of the strengths of the ICD lead but none of its
weaknesses.
After nearly nine years of development, the company
this week reported that it has begun trials of its
Subcutaneous Implantable Defibrillator (S-ICD) System, as
support for winning CE mark approval, a system that provides
ICD shock but without the need of leads inserted in or
near the heart.
The company said that 14 patients have received an S-
ICD System as part of the CE trial, which will enroll up to 55
patients at 10 centers in Europe and New Zealand.
Richard Sanders, VP of sales and marketing for
Cameron, told Medical Device Daily that the device was
designed by Bardy and Cappato, “who thought that there
must be a better way for ICD procedures.”
He added that the therapy “is very effective,” while also
acknowledging “potholes” in the process of development.
“The original concept was to completely alleviate the
need for any lead or electrode and incorporated a shoehorn-shaped
can which can be slipped under the skin and
over the ribs. The first generation of device, while not leadless,
accomplishes the same thing.”
Components of the Cameron Health S-ICD System
include the SQ-RX Pulse Generator, Q-TRAK Subcutaneous
Electrode, Q-GUIDE Electrode Insertion Tool and the Q-TECH
Programmer.
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The S-ICD System is implanted subcutaneously (just
under the skin), with the electrode running parallel and
slightly to the left of the sternum. While most functions are
automatic, adjustments and data retrieval can be easily
achieved through what the company says is an advanced
integrated programming system developed specifically for
the S-ICD System.
The company says that the Q-TECH programmer is one
of the smallest units in the industry, weighing less than
three pounds. And the light-weight, portable unit is capable
of wireless communication with the SQ-RX Pulse Generator.
To implant Cameron’s device, physicians and surgeons
need only surface anatomical landmarks, such as the
breastbone, without any imaging equipment.
Commenting on the clinical trial and the first CE trial
patient to receive the S-ICD System in New Zealand,
Margaret Hood, MD, in a release said, “Our initial experience
with this new technology has brought positive results. The
whole procedure was surgically simple. Once implanted,
the S-ICD System can be programmed to automatically
optimize the device parameters for monitoring the heart’s
rhythm while removing some of the complexity inherent in
conventional systems. Traditional ICDs are a bit more complicated
in their implantation and a bit more costly.
Conventional ICDs require placement of at least one
lead in or on the heart. Most frequently, these leads, constructed
of thin insulated wires, are threaded through a
vein and then placed inside the heart. These conventional
transvenous leads allow for sensing of the heart’s rhythm
and delivery of a life saving electric shock when a harmful
arrhythmia is detected.
But the surgical placement and residence of these
transvenous leads within the patient’s heart are associated
with a significant proportion of the complications related
to this well-established and highly effective therapy.
Those reports include patients receiving constant unnecessary
shocks and, in some cases – as with the case of the
Fidelis lead – death.
“So far feedback for (S-ICD) System has been extremely
favorable,” Sanders said.
The company said that that its expectation is to apply
for an investigation device exemption by the first quarter
of this year.
(This story originally appeared in the Aug. 5, 2009, edition
of Medical Device Daily)
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