The FlowGuard™ valved peelable venous introducer by Enpath Medical is a valved introducer available for implanting dialysis catheters. The proprietary valve reduces the risk of blood loss and air intake while allowing for smooth pacing lead and catheter insertion. FlowGuard requires no change in technique and features a low profile sheath handle and reliable peel performance. FlowGuard is now available in 14, 15 and 16 Fr sizes. Additional sizes available soon.
	FlowGuard™ Valved Peelable Venous Introducer   :: CONFIGURATIONS :: In bulk (non-sterile) :: Individual sterile packs :: In sterile procedure kits (call for kit configuration information) STANDARD SIZES (.035″ / .038″ guidewire compatible) FRENCH SIZE :: 14 15 16 SHEATH I.D. (IN) :: .190 .198 .209 SHEATH LENGTH (CM) :: 14 14 14 BULK MODEL NUMBER :: 10614- 009 10614- 010 10614- 011

Designed for vessel entry during placement of .035″ and .038″ guidewires, this system facilitates venous access with a small 21 gauge needle and a .018″ access wire. Enpath Medical coaxial dilator micro-introducers feature extremely smooth, atraumatic dilator and sheath tip transitions. Coaxial Dilator Micro-Introducer :: CONFIGURATIONS :: In bulk (non-sterile) :: In sterile procedure kits (call for kit configuration information) MICRO SIZES (.018″ guidewire compatible) INTRODUCER FRENCH SIZE SHEATH LENGTH (CM) BULK MODEL NUMBER 4.0 9 10489-001 4.5 9 10489-002 5.0 9 10489-003

	: overview : leads (2) : adapters (4) : implant tool (2)
	This unique tool has been developed specifically for addressing the challenges of surgically placing a sutureless, screw-in lead on the heart’s epicardial surface using mini-thoracotomy and thoracoscopic approaches. The FasTac® Flex works in conjunction with Enpath Medical’s MyoPore® line of sutureless epicardial leads to provide you with remote distal deflection capabilities, remote lead rotation for insertion of the helix into the myocardium, and remote lead release and regrasping capabilities.
	FasTac® Flex Epicardial Lead Implant Tool Specifications KEY FEATURES: –   Deflection from 0°-75° –   Ergonomic handle –   Easy to use articulating wheel and rotating collar –   Large collet surface area for lead stability –   Lead management groove prevents torque FastTac® Flex Implantation Techniques Video & Specs on CDRom Available upon request: info@enpathmed.com Materials Polycarbonate resin Thermoplastic elastomer Stainless Steel Length Overall length 44 cm Shaft length 22 cm Shaft Angle 0°-75° Shaft Diameter 14.2 mm Recommended min port size 15mm
	The FasTac® implant tool for the insertion of MyoPore® leads onto the surface of the ventricular epicardium of the heart is supplied in every MyoPore lead package. The unique design of the implant tool allows for a quick, one-handed motion for release of the lead after attachment. The distal end of the tool is designed to provide simple, fast regrasping, reloading and repositioning of the lead, if necessary.
	FasTac® Myocardial Lead Implant Tool Length Packaged With KEY FEATURES: –   Releases lead with quick, one-handed motion –   Lead can easily be regrasped and unscrewed for repositioning –   Reloading of the lead onto the implant tool takes seconds –   Bidirectional tunneler has an attachable tip for tunneling from the pocket to the heart Implant Tool (cm) 27 All MyoPore lead models Tunneler (cm) 27 All MyoPore lead models Lead End Cap   All MyoPore leads in case of prophylactic lead placement

Enpath Medical has been providing a number of different IS-1 adapters to the industry in order to connect old 5mm/6mm unipolar leads, 5mm bifurcated bipolar leads, and 3.2mm bipolar leads to newer pulse generators conforming to the international pacemaker connector standard IS-1. Enpath Medical has also been involved with the AAMI Pacemaker Connector Standards Committee that has been working on the new IS-4 connector standard over the past four years, with the intention of supplying selected IS-4 adapters to the industry once the connector standard has been determined. 5mm :: Unipolar Lead to IS-1 Unipolar Connector Model Number 501203     APPLICATION: For adapting a unipolar lead with 4.75mm (5mm) connector to a pacemaker with an IS-1 unipolar receptacle. PACKAGE CONTENTS: –   1 Adapter –   3 Hex Wrench/Set Screw Assemblies Length (cm) 13     Insulation HP Silicone     6mm :: Unipolar Lead to IS-1 Unipolar Connector Model Number 501204     APPLICATION: For adapting a unipolar lead with 5.6mm (6mm) connector to a pacemaker with an IS-1 unipolar receptacle. PACKAGE CONTENTS: –   1 Adapter –   3 Hex Wrench/Set Screw Assemblies Length (cm) 13     Insulation HP Silicone     5mm :: Bipolar Bifurcated Lead to IS-1 Bipolar Connector Model Number 501205     APPLICATION: For adapting a bipolar lead with a 5mm bifurcated connector to a pacemaker with an IS-1 bipolar receptacle. PACKAGE CONTENTS: –   1 Adapter –   3 Hex Wrench/Set Screw Assemblies Length (cm) 15     Insulation HP Silicone     3.2mm :: Low-Profile Bipolar Lead to IS-1 Bipolar Connector Model Number 501206 501214   APPLICATION: For adapting a bipolar lead with a 3.2mm low-profile connector to a pacemaker with an IS-1 bipolar receptacle. PACKAGE CONTENTS: –   1 Adapter –   3 Hex Wrench/Set Screw Assemblies Length (cm) 14 47   Insulation HP Silicone HP Silicone

Quality

As a product development and manufacturing company it is our goal to produce exceptional products. We understand the quality systems and regulatory compliance issues your company faces. Our Quality Engineering and Regulatory team can offer design control assistance and regulatory submission support. Lead Technologies division produces our own Class III active implantable leads. We are ISO-9001:1994/EN 13485:2000 certified, FDA registered, and CE Mark approved.

Delivery systems division produces class II introducers and class III steerable sheaths (Deflectable Catheters). We are ISO 13485:2003 with CMDCAS recognized registrar, FDA registered, CE marked, and ISO 9001:1994 certified.

Enpath Medical provides a variety of specialized lead and deflectable sheath services. Enpath offers the full spectrum of development from product concept through manufacturing to commercialized distribution. All of these services are provided by an in-house staff of research and development engineers, manufacturing engineers, technicians, and skilled operators with product experience.

Enpath Medical’s current product line of pacing leads is composed of permanent, sutureless, epicardial leads (MyoPore®) and an innovative implant tool (FasTac®). Enpath Medical offers both unipolar and bipolar models in a number of different lengths from 25cm to 54cm. This epicardial lead technology has been on the market since 1989 and continues to perform reliably after more than 20,000 implants worldwide. MyoPore® :: Sutureless Unipolar Epicardial Pacing Lead Model Number 511111 511112 KEY FEATURES: –   Platinized 10mm2 electrode for improved pacing and sensing performance –   Low profile construction for reduced electrode head size –   Quadrifilar conductor for added safety and durability –   Full 3.5mm electrode penetration for reliable fixation, pacing and sensing Length (cm) 35 54 Connector Type IS-1 Uni IS-1 Uni Unipolar Resistance (Ohms) 27 41 Electrode Surface Area (mm2) 10 10 Insulation HP Silicone HP Silicone MyoPore® :: Sutureless Bipolar Epicardial Pacing Lead Model Number 511210 511211 511212 KEY FEATURES: –   Platinized 10mm2 electrode for improved pacing and sensing performance –   Low profile construction for reduced electrode head size –   Quadrifilar inner conductor for added safety and durability –   Full 3.5mm electrode penetration for reliable fixation, pacing and sensing –   Quadrichannel anode electrode provides increased surface area for enhanced sensing Length (cm) 25 35 54 Connector Type IS-1 Bi IS-1 Bi IS-1 Bi Cathode Unipolar Resistance (Ohms) 23 27 41 Anode Unipolar Resistance (Ohms) 32 46 75 Cathode Surface Area (mm2) 10 10 10 Anode Surface Area (mm2) 62 62 62 Insulation HP Silicone HP Silicone HP Silicone

Enpath Medical develops and manufactures its own product line of implantable pacing leads, lead adapters, and lead delivery systems. Enpath’s proprietary lead products are protected by a number of issued patents in the U.S. and Europe. Enpath continues to invest in the development of specialized lead products and delivery systems to serve the needs of smaller, market niches. Enpath’s lead, adapter, and delivery system products are intended to be sold through the major OEM companies as additions to their product lines in the markets of Cardiac Rhythm Management, Neuromodulation, and Hearing Restoration.

Enpath Medical does not sell products directly to end users.

At Enpath Medical we pride ourselves on our commitment to quality, innovation, and most importantly customer service.

You can count on Enpath to lead the way to safer and simpler medical procedures through innovative products and solutions.

Medamicus Inc. founded in 1985 First Proprietary product, the Slittable introducer launched in 1990 Medamicus Inc initial public offering 1991 Initiated a new focus on vascular access business in 1999 leads to significant growth in both sales and number of customers Launch of Axia RSN safety needle 2001 Lumax Fiber-optic system, launched in 1995, sold to Cooper Surgical in 2001 Medamicus acquires Biomec Cardiovascular October of 2003 Biomec Cardiovascular and Medamicus become Enpath Medical in February 2004 Enpath Medical Inc launches new website July 2004 CE approved for MyoDex steroid epicardial lead March 2005 FDA approval for the Steerable Sheath (Deflectable Catheter) May 2005 CE approval for the Steerable Sheath (Deflectable Catheter) December 2005