This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Stratos LV and Stratos LV T CRT Ps and Corox OTW BP and Corox OTW S BP Left Ventricular Pacing Leads
PMA Applicant: Biotronik Inc.
Address: 6024 Jean Road, Lake Oswego, OR 97035
Approval Date: May 12, 2008
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf7/p070008a.pdf
What is it? The Stratos LV (-T) Cardiac Resynchronization Therapy Pacemakers (CRT-P) are rate adaptive pulse generators that also provide Cardiac Resynchronization Therapy (CRT) for patients with heart failure. The systems consist of four separate components:
- A titanium can containing a battery and electronic circuitry that provides multiple therapies,
- Three insulated lead wires that connect the CRT-P to the patient’s heart, including the Corox OTW BP and Corox OTW‑S BP left ventricular pacing lead
How does it work? The CRT-P is surgically implanted below the collarbone, just beneath the skin. One lead is placed in an upper heart chamber (the right atrium), a second lead is placed in the right lower heart chamber (right ventricle), and a third lead is placed in a vein that overlies the left lower heart chamber (left ventricle).
The Cardiac Resynchronization Therapy (CRT) coordinates the beating of the left and right ventricles so they work together to more effectively pump blood throughout the body. In addition, the pacemaker will pace the heart to treat slow or abnormal heart rhythms.
The Stratos LV-T CRT-P also has BIOTRONIK’s Home Monitoring technology that allows a physician to remotely monitor performance of a patient’s implanted system and condition via the Internet.
When is it used? The CRT-P pacemakers are for use in patients who have moderate to severe heart failure (NYHA Class III/IV). They are indicated for use in patients who:
- exhibit symptoms related to heart failure (left ventricular dysfunction (EF≤ 35%) and QRS ≥ 120 ms)
- remain symptomatic despite stable, optimal heart failure drug therapy
The Corox OTW(-S) BP left ventricular pacing leads are bipolar steroid‑eluting leads, intended for permanent implantation in the left ventricle via the coronary veins to provide pacing and/or sensing when used in conjunction with a compatible IS-1 pulse generator.
What will it accomplish? The CRT-P system provides coordinated, simultaneous stimulation of the right and left ventricles as well as standard pacemaker therapy. This resynchronization (or biventricular) pacing coordinates the contraction of both ventricles, which allows the heart to contract more efficiently. As a result, patients with heart failure and intraventricular conduction delay may have a greater ability to complete physical activities and therefore improve their quality of life.
When should it not be used? Unipolar pacing with CRT-Ps should not be used if the patient has an ICD. Dual chamber and single chamber atrial pacing should not be used in patients with chronic refractory atrial tachyarrhythmias. Additionally, single chamber atrial pacing should not be used for patients with impaired AV nodal conduction.
The Corox OTW lead system should not be used in patients with any anomalies of the venous system that preclude transvenous implantation of the lead, in patients who have coronary sinus anomalies, in patients that have tissue in the coronary sinus area that has been damaged by an infarction, or in patients that cannot tolerate a single system dose of dexamethasone acetate (DXA).
Additional information: The Summary of Safety and Effectiveness and labeling is available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p070008