Novel String-Shaped Implantable Defibrillator Proves Effective - In Treating Patients with Irregular Heartbeats

CHICAGO, May 12, 2017 - A new study examines the effectiveness of the Implantable Subcutaneous String Defibrillator (ISSD™), a flexible, string-shaped and first-ever rechargeable implantable cardioverter-defibrillator (ICD). This is the first-in-man study to report on the feasibility of the innovative device and was presented today at Heart Rhythm 2017, the Heart Rhythm Society`s 38th Annual Scientific Sessions.

Each year, about 300,000 worldwide receive an ICD to protect against irregular heartbeats.1 In fact, ICDs are proven to be 98 percent effective in treating dangerous ventricular (VT) arrhythmias that can lead to sudden cardiac arrest.2-3 Although traditional ICDs have been utilized to deliver painless pacing therapy, a subcutaneous (under the skin) ICD does not require leads, but requires an electrically active, metal-encased generator (or can) implanted over the ribs.

The new, first-of-its-kind ISSD™ was designed by NewPace Ltd. in an effort to eliminate the need for an active generator and places only small, flexible device including coils below and over the ribs and totally subcutaneously. The ISSD™ does not have leads within the heart nor an implantable pulse generator (or can) and provides a minimally invasive approach compared to the S-ICD™, because it only requires two very small incisions with no need to create a pulse generator pocket. This results in minimal anatomical protrusion, for improved patient comfort and aesthetic appearance.

The study enrolled 22 patients ages 69.5 ±8.9 years and 82 percent male with BMI 26.9±3.5 and LVEF 28.9±8.2. The common diagnoses for which the ISSD™ was used included: nonischemic cardiomyopathy (18 percent), prior cardiac surgery (14 percent), and primary prevention patients (91 percent). The average implant time was 20 minutes and results include an average defibrillation testing threshold (DFT) of 25.8 joules and a SD of 10.7 joules in successfully screened patients.