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The indications/contraindications for use of the PIKOS products are identical to those for all single chamber (AAI or VVI) pulse generators. The use of multi-programmable, single chamber pacemakers is indicated as a therapeutic modality for control of heart rate, provided that implantation is preceded by an adequate diagnostic check, and no parameter values dangerous for the patient are programmed. The use of the pacemaker in the atrium is contraindicated in the case of AV conduction disorder, and if atrial fibrillation or atrial flutter are exhibited. Ventricular pacing is not indicated in patients who already showed a pacemaker syndrome especially if a dual chamber pacemaker can be used. Pikos single chamber pacemakers, Models 01/01-A/E01/LP 01/LP E01/E01-B pacemakers are indicated for the following: - Symptomatic paroxysmal or permanent second or third-degree AV block . - Symptomatic bilateral bundle branch block . - Symptomatic paroxysmal or transient sinus node dysfunctions with or without . associated AV conduction disorders - . Bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias - Vasovagal syndromes or hypersensitive carotid sinus syndromes .

BIOTRONIK requests clearance of the NIPS (Non-Invasive Programmed Stimulation) feature for BIOTRONIK's family of Pikos pulse generators. NIPS is provided as a feature in each of these pulse generators by allowing access to the NPS software drivers that were previously locked out. Each of these pulse generators has been FDA approved for use with P950037/S8, dated 08-24-99). The affected members of the Pikos family are comprised of the following pulse generators. Unlocking the NIPS feature within the programmer software allows a previously implanted pulse generator and lead system to invoke high rate pacing and perform a variety of cardiac electrophysiological (EP) studies. The NIPS feature is generated entirely through the existing pulse generator and lead system. This feature is controlled by the programmer and activates the pulse generator only when the wand is placed directly over the device. There are no other external devices required for this system. The NIPS feature is approved for each pulse generator listed above outside the US, but has been blocked from the Pikos devices through BIOTRONIK's software lock. The NIPS feature will be unlocked for each member of the Pikos family with a release code to the B-HXX.0.U programmer software. BIOTRONIK will identify the software version as B-H02.0.U. There are no hardware changes to any of the pulse generators or the EPR 1000"-10 programmer system to allow this feature. The primary functions of these pulse generators, th system and the B-H02.0.U software remain the same.

- AV conduction disorders or intraventricular paroxysmal/permanent conduction disorders with permanent atrial tachycardia: atrial fibrillation or flutter (lead implanted in the ventricle), - Sinus bradycardia, sinoatrial block, brady-tachy syndrome without atrioventricular conduction disorder (lead implanted in the atrium).

Opus S, Model 4121 and 4124 are single-chamber programmable pacemakers. The electronic circuit and battery are encapsulated in a hermetic titanium case. Pacing leads are connected through a medical grade silicone elastomer connector. The different functions are assured by a hybrid circuit with passive components and integrated circuits (microprocessor and custom circuit). The programmer system consists of a programming head, programmer software, and an IBM-compatible PC.

The Pikos LP 01/LP B01 models, like the Pikos 01/E01 models, are indicated for use in the following conditions: - · Sinus node arrest or bradycardia with or without AV conduction disorder. - · Intermittent or complete AV conduction block. - · Brady/tachy syndrome or other manifestation of sick sinus syndrome which results in symptomatic bradycardia. - · Atrial fibrillation and ventricular bradyarrhythmia.

The Pikos LP 01/LP B01 is a multi-programmable single chamber pulse generator which is designed and recommended for use with atrial or ventricular leads. The Pikos LP 01/LP E01 models offer a limited number of programmable options compared to those of the Pikos 01/E01 models.