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BIOTRONIK's endocardial leads are designed for use with implantable pulse generators that require pacing leads with a bipolar IS-1 connector configuration they may be used with single or dual chamber pacing systems. The leads are designed for use in patients for whom single or dual chamber pasing of pasing therapy is medically indicated. This indication for them single of the Class I definition of the ACC/AHANASPE This Indication This Indication inal recommended in Title Class I demind of the of Cardiac Pacemakers Reports, Aladoa Aloon More 2 2002 Ghuelle Opdate of Inplantabon CordialemyAmadon Mond Anad Anada Arabarhythmia Devices: A Report of the American Colleg CardiologyAmerican Heart Association Task Force on Practice Guidelines (ACCAHANASPE Committee on Pacemaker Implantation)" (Gregoratos et al. 2002). The straight lead models are intended for placement in either the right atrium or right ventricle. The JBP lead models have a pre-formed distal end to facilitate lead placement in the ight atrial appendage.

BIOTRONIK proposes modifications to the packaging process and containers for bradycardia pacing leads, at BIOTRONIK's manufacturing and sterilization facility (BIOTRONIK GmbH & Co. KG) in Pertin, Germany and contract manufacturing facility (BIOTRONIK AG) in Bülach Switzerland.

Permanent pacing lead, Model PY2, is indicated for pacing and sensing of the ventricle. The permanent pacing lead, Model PY2, is used in conjunction with a compatible, market cleared, implantable pulse generator (pacemaker).

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Permanent pacing lead, Model Refino ™ is indicated for pacing and sensing of the ventricle and / or atrium of the heart. The lead is used in conjunction with a compatible implantable pulse generator (pacemaker).

Permanent Pacing Lead, Model Refino

The Medtronic Model 5071 sutureless, unipolar, myocardial, screw-in lead is designed for ventricular pacing and sensing. The lead has application where permanent ventricular or dual-chamber pacing systems are indicated.

The Medtronic Model 5071 sutureless, unipolar, myocardial, screw-in lead is designed for ventricular pacing and sensing. The lead has application where permanent ventricular or dual-chamber pacing systems are indicated. Two leads may be used for bipolar pacing. The lead's screw-in electrode is designed to be secured to the myocardium with two clockwise turns. A polyester mesh allows fibrous ingrowth for additional fixation. The lead requires no stab wounds or sutures for electrode placement and fixation. Tissue damage from electrode insertion may be compared to the insertion of a 15guage needle. The lead features a MP35N nickel alloy conductor, silicone rubber insulation, and an IS-1 Unipolar (UNI) lead connector.

The Medtronic Model 4951M Myocardial, IS-1 Unipolar Lead is designed for pacing and sensing in either the atrium or ventricle. The lead has application where an implantable atrial, ventricular or dual-chamber pacing system is indicated.

The Medtronic Model 4951M Myocardial, IS-1 Unipolar Lead is designed for pacing and sensing in either the atrium or ventricle. The lead has application where an implantable atrial, ventricular or dual-chamber pacing system is indicated. Two leads may be used for bipolar pacing. The lead features a platinized electrode that can be secured to the heart by gently pushing the barbed tip into the epicardium and securing it in myocardial tissue. Suture holes in the polyurethane base pad are provided for greater security. A polyester mesh allows for fibrous ingrowth for additional fixation. The lead also features an MP35N nickel alloy conductor, polyurethane insulation, and an IS-1 Unipolar (UNI) lead connector.

BIOTRONIK's ELOX P transvenous, active fixation endocardial leads are indicated for permanent pacing and sensing. Active fixation pacing leads with a bipolar (BP) IS-1 connector configuration are designed for use in conjunction with implantable pulse generators with IS-1 headers. The leads may be used with single or dual chamber pacing systems. The ELOX P lead models are intended for placement in either the right atrium or right ventricle.

Elox P leads are straight, bipolar endocardial pacing leads that utilize an electrically active extendable/retractable fixation helix. The extendable/retractable fixation helix is comprised of a 70% Pt / 30% Ir alloy with a fractal tridium coating. The fixation helix is additionally coated with Parylene C. The non-insulating distal sleeve, consisting of an inner and outer sleeve, is composed of Polyurethane (Pellethane 2363-75D). The leads contain two conductors composed of quadrifilar MP35N wire in coaxial configurations and are insulated with silicone tubing. A 3.2 mm 15-1 bipolar connector attaches the lead to the pulse generator. The Elox P lead is available in lead lengths of 45 cm, 53 cm, and 60 cm.

Permanent pacing lead, Model Physique™ is indicated for pacing and sensing of the ventricle and/or atrium of the heart. This lead is used in conjunction with a compatible implantable pulse generator (pacemaker).

Permanent Pacing Lead, Model Physique™

Arox and Merox bipolar, passive-fixation, endocardial pacing leads are intended to provide permanent pacing and sensing in the atrium and or ventricle when used with a compatible pulse generator.

The BIOTRONIK Arox and Merox leads are bipolar, passive-fixation, endocardial pacing leads available in straight and "J"-shaped configurations, for placement in the ventricle or atrium. The Arox and Merox xx-JBP models have a permanent bend proximal to both lead electrodes, resulting in the distal portion of the lead body having what is commonly referred to as a "U" or "J" shape. This lead shape facilitates placement in the right atrial appendage. The device modification only applies to the atrial Arox xx-JBP bipolar, passive-fixation, endocardial, pacing leads. The modification consists of an exact specification for the J-shape of the leads.

Arox bipolar, passive-fixation, endocardial pacing leads (Arox xx-BP and Arox xx-JBP) are intended to provide permanent pacing and sensing in the atrium and or ventricle when used with a compatible pulse generator.

The BIOTRONIK Arox lead is a bipolar, passive-fixation, endocardial pacing lead available in straight and " J"-shaped configurations, for placement in the ventricle or atrium. The designation Arox xx-BP refers to Arox straight leads, which are available in lengths (xx) of 53 or 60 cm; Arox xx-JBP refers to Arox "J"-shaped leads, which are available in lengths of 45 and 53 cm. The Arox xx-JBP model has a permanent bend proximal to both lead electrodes, resulting in the distal portion of the lead body having what is commonly referred to as a "U" or "J" shape. This lead shape facilitates placement in the right atrial appendage. Arox xx-BP and Arox xx-JBP leads feature four silicone tines for passive-fixation in the heat's trabeculae. The tip electrode is made of a platinum/iridium base material, with a fractal iridium surface and electrically active surface area of 3.5 mm². The ring electrode is made of a platinum/iridium base material, with a fractal iridium surface and electrically active surface area of 22.6 mm². The lead conductor consists of quadrifilar MP35N wire in a coaxial configuration, insulated with silicone rubber tubing. All Arox leads utilize a 3.2 mm IS-1 connector.