Biotronik, Inc.

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Contact: Jon Brumbaugh
Web: http://www.biotronikusa.com
E-Mail:
Address: 6024 Jean Rd., Lake Oswego, Oregon 97035, USA
Phone: +1-(800)-5470394 | Fax: +1-(800)-2910470 | Map/Directions >>

Profile: Biotronik, Inc. focuses on devices for vascular intervention and electrotherapy of the heart. Our Setrox S is a 6.7 F active fixation lead designed for handling and deliverability via a flexible distal tip. Fractal coating and steroid elution ensures optimal electrical performance. Philos™ family has an extensive arrhythmia management functions, support of the heart's natural rhythm and automatic parameter optimization provide both physician and patient with the possible flexibility and reliability. It ensures optimal thresholds over the life of the system, from acute to chronic. Cylos is a one-touch programming and patient management using the home monitoring service offer benefits to both patients and the physicians. This pacemaker is used in physiologic rate-adaptive algorithm and wireless transmissions for arrhythmia monitoring and event notifications.

FDA Registration Number: 1028232

19 Products/Services (Click for related suppliers)

• Active Fixation Lead, bipolar

• Automatic Implantable Cardioverter Defibrillator With Cardiac Resynchronization (FDA Code: NIK)

• Cardiac Pacemakers

• Cardiac Resynchronization Therapy Device (Cardiology, Vascular Surgery)

• Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes (FDA Code: NVN)

• Drug-Eluting Permanent Defibrillator Electrodes (FDA Code: NVY)

• Dual-Chamber Implantable Defibrillator (FDA Code: MRM)

• External Pacemaker Pulse Generator (FDA Code: DTE / 870.3600)

An external pacemaker pulse generator is a device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device, which is used outside the body, is used as a temporary substitute for the heart's intrinsic pacing sytem until a permanent pacemaker can be implanted, or to control irregular heartbeats in patients following cardiac surgery or a myocardial infarction. The device may have adjustments for impulse strength, duration, R-wave sensitivity, and other pacing variables.

• Guidewire Catheter (FDA Code: DQX / 870.1330)

A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

• Implantable Pacemaker Pulse Generator With Cardiac Resynchronization (FDA Code: NKE)

• Implantable Permanent Pulse Generator (FDA Code: NVZ)

• Pacemaker Electrode Function Tester (FDA Code: DTA / 870.3720)

A pacemaker electrode function tester is a device which is connected to an implanted pacemaker lead that supplies an accurately calibrated, variable pacing pulse for measuring the patient's pacing threshold and intracardiac R-wave potential.

• Pacemaker Lead Adaptor (FDA Code: DTD / 870.3620)

A pacemaker lead adaptor is a device used to adapt a pacemaker lead so that it can be connected to a pacemaker pulse generator produced by a different manufacturer.

• Pacemaker Programmer (FDA Code: KRG / 870.3700)

A pacemaker programmer is a device used to change noninvasively one or more of the electrical operating characteristics of a pacemaker.

• Percutaneous Catheter (FDA Code: DQY / 870.1250)

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

• Percutaneous Catheterization Vessel Dilator (FDA Code: DRE / 870.1310)

A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.

• Peripheral Transluminal Angioplasty Catheter (FDA Code: LIT / 870.1250)

• Permanent Cardiac Pacemaker (FDA Code: DTB / 870.3680)

A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.

• Programmable Implantable Heart Pacemaker (FDA Code: DXY / 870.3610)

An implantable pacemaker pulse generator is a device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device is used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders. This device includes triggered, inhibited, and asynchronous devices implanted in the human body.