Feature | December 05, 2012| Dave Fornell

FDA Clears First Subcutaneous ICD System

S-ICD System eliminates venous heart leads, greatly simplifying implantation in patients at risk of sudden cardiac arrest

S-ICD, subcutaneous ICD

The S-ICD uses a lead that runs just under the skin, above the heart, eliminating the need for transvenous leads and securement inside the heart, which greatly simplifies the procedure and reduces possible complications.

To see the video highlights from the presentation of the S-ICD U.S. pivotal trial data at the Heart Rhythm Society (HRS) 2012 meeting, visit http://bit.ly/Mc8Kiw.

To view a short video presentation of how the S-ICD System is implanted, visit http://bit.ly/QsUuku.

The U.S. Food and Drug Administration (FDA) in October granted Boston Scientific Corp. regulatory approval for its S-ICD System, the world’s first commercially available subcutaneous implantable cardioverter defibrillator (S-ICD).  The system sits entirely just below the skin without the need for implantable lead to be placed inside the heart. This offers patients an alternative to transvenous ICDs, which require leads to be placed in the heart itself.

“The S-ICD System establishes the first new category of cardiac rhythm management devices since the introduction of cardiac resynchronization therapy,” said Raul Weiss, M.D., associate professor of clinical and cardiovascular medicine at The Ohio State University in a press release. “Doctors now have a breakthrough treatment option that provides protection from sudden cardiac arrest without touching the heart.”

The S-ICD System was the star of the Heart Rhythm Society (HRS) annual meeting in May. Several experts at HRS said it is widely expected to revolutionize ICD implantation and greatly expand its implant base because of its simplied procedure and low complication rate.  The booth of Cameron Health (developer of the technology) was packed with interested electrophysiologists (EPs), and several sessions discussed the device, including a late-breaking session on the U.S. pivotal trial. 

In June, Boston Scientific finalized a deal to purchase Cameron Health and the S-ICD technology, which it expects to greatly boost its EP portfolio as the only subcutaneous ICD on the market. Boston Scientific expects to begin a phased launch of the S-ICD System that will expand over time as medical professionals are trained to implant it. 

Simplified Implantation

A large number of patients in the United States who need ICDs do not receive the devices, partly because the implant procedures are invasive and require venous leads implanted in the heart. The S-ICD system will likely prove a more palatable option for these patients, said Martin Burke, D.O., FACC, FACOI, FRCP, professor of medicine, University of Chicago Hospitals, who is involved in the U.S. trial for the S-ICD system. Of the 13 percent of patients in the U.S. trial who had a previous ICD, only two opted for venous leads when offered the choice of the S-ICD system.

“It’s definitely a simpler implant than a venous implant,”
he explained. 

An average venous lead implant procedure takes one to six hours depending on many variables, but an average S-ICD implant takes a very predictable one hour and 15 minutes, Burke said. 

“The system has been very well accepted, the patients all love it,” Burke said. “Patients get this system, they like the fact that there is nothing in the heart.” 

In addition to a simple installation, the programming of the device is also designed to be extremely easy to use, using one screen and having only three options. 

European Experience

The S-ICD system was introduced in Europe in 2009 and more than 1,400 devices have been implanted in patients around the world. Pier D. Lambiase, M.D., Ph.D., FRCP, lead author, senior lecturer, honorary consultant cardiologist at Heart Hospital, University College of London, gained experience with the device in the United Kingdom and agrees the system is extremely easy to use.

“The learning curve is pretty steep. With two procedures you can get pretty proficient,” Lambiase said. “It will lower the threshold for implanting these devices.” 

In addition, the easier, less invasive procedure is expected to greatly reduce complications and make lead extraction easier when it comes time for their regular replacement. Lambiase said there is no chance of heart valve damage and no possibility of venous perforation. 

In the United Kingdom, Lambiase said the S-ICD so far has been shown to have the same cost equivalent as a traditional ICD. However, he explained the ease of the implant allows for increased procedure volume. He also expects, as a larger number of these devices are implanted, there will be a cost savings due to lower complication rates, especially lead infections. 

Elimination of Fluoroscopy

Another advantage of the S-ICD device is its elimination of ionizing radiation to implant the leads, because the whole implant is done with direct visualization using anatomical landmarks.

“You don’t need fluoroscopy for this procedure,” Burke said. “I walked into the procedure room without lead on for the first time and I felt a little naked.”

Simple to Use, But Still the EP’s Domain

The simplicity of the S-ICD system has raised the question of whether ICDs can or should be implanted by cardiologists outside the specialty of electrophysiology.  While the device is designed for ease of use, Burke warns that at this point only electrophysiologists should be implanting these devices. He said it is important during the initial phase of use in the United States to show the safety of the device with the use of experienced operators. 

Indications for Use

The S-ICD System is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with antitachycardia pacing. 

Video: How to Implant the S-ICD System

To view a short video presentation of how the S-ICD System is implanted, click here

Video: Highlights of the S-ICD System U.S. Pivotal Trial 

 

To see the highlights from the presentation of the S-ICD U.S. pivotal trial data at the Heart Rhythm Society (HRS) 2012 meeting, click here.  

 

Related Content

Feature | Inventory Management| April 28, 2017 | Dave Fornell
Tracking cardiovascular device inventory in cath labs, electrophysiology (EP) labs and operating rooms (ORs) can be a
AtriCure's AtriClip System Surpasses 100,000 Units Sold Worldwide
News | Left Atrial Appendage (LAA) Occluders| April 25, 2017
AtriCure Inc. announced it has sold more than 100,000 AtriClip Left Atrial Appendage Exclusion System devices worldwide...
Clinical Study Validates Efficiencies of Stereotaxis Niobe ES System Over Niobe II System
News | Robotic Systems| April 24, 2017
A recent study conducted at Centre Hospitalier Universitaire (CHU) of Saint-Étienne, France validated the advantages of...
Digital Health Company Murj Announces $4.5 Million in Financing
News | Implantable Cardiac Monitor (ICM)| April 19, 2017
Murj Inc., a digital health company that helps manage implantable cardiac device data, announced more than $4.5 million...
NICE Recommends Boston Scientific CRT-Ds With EnduraLife Battery Technology for Heart Failure Treatment
News | Cardiac Resynchronization Therapy Devices (CRT)| April 14, 2017
The National Institute for Health and Care Excellence (NICE) recently issued medical technology guidance recommending...
The Unify ICD is one of the SJM devices in an FDA warning letter
Feature | Implantable Cardioverter Defibrillators (ICD)| April 14, 2017 | Dave Fornell
April 14, 2017 — The U.S. Food and Drug Administration (FDA) sent a warning letter to Abbott/St.
An electrophysiology EP ablation procedure to treat a heart arrhythmia
Feature | HRS| April 14, 2017
April 14, 2017 — The Heart Rhythm Society (HRS) has announced its late-breaking clinical trials at its annual meeting
Vascular Dynamics Completes $10.4 Million Financing for MobiusHD System
News | Hypertension| April 13, 2017
Vascular Dynamics Inc. (VDI) a privately held medical device company developing novel solutions for the treatment of...
Biotronik Launches New ICD Lead With Helical Design in Europe
News | Leads Implantable Devices| April 12, 2017
Biotronik announced the European launch of a new lead for tachycardia therapy that features a helical design for...
The Arctic Front Advance Cardiac CryoAblation Catheter treats atrial fibrillation with pulmonary vein isolation
News | Atrial Fibrillation| April 11, 2017
April 10, 2017 — Medtronic recently announced the first enrollments in the STOP Persistent AF clinical trial.
Overlay Init