Cameron
Health, Inc. today announced the commencement of the company's
pivotal clinical trial to gain U.S. approval of its Subcutaneous
Implantable Defibrillator (S-ICD®) System. The minimally
invasive S-ICD System is prescribed for use in patients at risk of
Sudden Cardiac Arrest (SCA). The S-ICD System is unique in that the
implantation of the system is entirely subcutaneous; no leads are in or
on the heart. Additionally, there is no imaging equipment required for
placement of the S-ICD System, as all of the components are positioned
using anatomical landmarks. The S-ICD System received CE approval in
2009 and is commercially available in Europe.
“I chose this novel technology
because I just like the idea of not having any leads in or on my heart.”
Conventional ICD’s 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. The surgical placement and long term
implantation of these transvenous leads within the patient’s heart are
associated with a significant proportion of the complications related to
this highly effective therapy. In contrast, the Cameron Health S-ICD
System resides just under the skin, potentially avoiding many of the
complications associated with the conventional implant procedure.
Cameron Health’s trial is a prospective, multicenter, single-arm design
approved by the FDA under an investigational device exemption (IDE). The
company plans to enroll up to 330 subjects at up to 35 sites globally.
The study has primary clinical endpoints of arrhythmia conversion
efficacy and complication free rate at 6 months for patients at risk of
SCA.