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 and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Tupos LV/ATx and Kronos LV-T CRT-Ds and Corox OTW Steroid Lead
PMA Applicant: Biotronik Inc.
Address: 6024 Jean Road, Lake Oswego, OR 97035
Approval Date: August 10, 2006
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf5/p050023a.pdf
What is it? The Tupos LV/ATx and Kronos LV-T Cardiac Resynchronization Therapy Defibrillator (CRT-D) Systems are Implantable Cardioverter Defibrillators (ICDs) that also provide Cardiac Resynchronization Therapy (CRT) for patients with heart failure who need an ICD. 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 ICD to the patient’s heart, including the Corox OTW Steroid left ventricular pacing lead
How does it work? The CRT-D 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 (ventricle), and a third lead is placed in a vein that overlies the left lower heart chamber.
When the CRT-D senses dangerous abnormal heart rhythms (arrhythmias), it shocks the heart into a normal rhythm. 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.
The Kronos LV-T CRT-D 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-D Systems are for use in patients who have heart failure and are at risk of sudden cardiac death. They are indicated for use in patients who:
- have abnormally fast heart arrhythmias (indicated for an ICD)
- exhibit symptoms related to heart failure
- receive optimized and stable Congestive Heart Failure (CHF) medicines
The Tupos LV/ATx is also indicated for patients who, in addition to an indication for a CRT-D device, have atrial tachyarrhythmias or are at risk of developing atrial tachyarrhythmias.
The Corox OTW Steroid leads are intended for implantation via the coronary veins to provide long term cardiac pacing when used in conjunction with a compatible pulse generator.
What will it accomplish? W hen the CRT-D senses dangerous abnormal heart rhythms, it shocks the heart into a normal rhythm and prevents sudden cardiac death. The system has also been shown to relieve many of the symptoms associated with heart failure, including shortness of breath and fatigue during exercise, and may result in a better quality of life.
When should it not be used? CRT-D systems should not be used if the heart failure or life-threatening heart rhythm abnormalities are reversible or temporary. The systems also should not be used in patients who have frequent episodes of an abnormally fast heart rhythm or whose only disorder is a slow and/or irregular heart rhythm.
- 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 or in patients that cannot tolerate a single systemic dose of dexamethasone acetate (DXA).
Additional information: Summary of Safety and Effectiveness and labeling are available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p050023
- American Heart Association:
- Information on Cardioverters: http://188.8.131.52/presenter.jhtml?identifier=11227
- Information on Healthy Lifestyle: http://184.108.40.206/presenter.jhtml?identifier=1200009
- Information on How the Heart Works: http://220.127.116.11/presenter.jhtml?identifier=1557
- Information on tachycardia: http://www.nlm.nih.gov/medlineplus/ency/article/000187.htm