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The Genzyme Surgical Products Millennium Valve Introducer/Rotator Handle is indicated for use during open and minimally invasive cardiac valve surgeries. This instrument is indicated for surgical introduction and rotation of a Sulzer Carbomedics Low Profile Mitral Valve Sizer and Rotator.

The Millennium Valve Introducer/Rotator Handle (Introducer/Rotator Handle) consists of a handle, flexible shaft, and tip. The Handle includes two knobs that control the orientation and position of the tip. The proximal knob tightens the cable that adjusts the tip between 0 and 90 degrees. The distal knob rotates the tip between 0 and 360 degrees.

The Sulzer Carbomedics Low Profile Mitral Rotator is intended for use in rotating the CPHV™ mitral valve in situ when necessary to avoid anatomical obstruction.

The sterile, single use Sulzer Carbomedics Low Profile Mitral Rotator is intended for use in rotating the CarboMedics® Prosthetic Heart Valve (CPHV™) mitral valve in situ when necessary to avoid anatomical obstruction. The Sulzer Carbomedics Low Profile Mitral Rotator design includes a socket that the bendable is inserted into and locked in place. This allows the surgeon to orient the valve into the position of greatest advantage for each patient. The Low Profile Mitral Rotator with the corresponding CPHV size on the rotator. The Low Profile Mitral Rotator will be made available in sizes corresponding with previously approved CPHV™ sizes. The Low Profile Valve Rotators are intended for use with the CPHV™ Mitral 700 valve series. The Sulzer Carbomedics Low Profile Mitral Rotator will be manufactured from polyetherimide previously used with instrumentation approved with the CPHV". Polyetherimide has a history of use in medical device applications.

The reusable CarboMedics Mitral Rotators are intended for use in rotating the CarboMedics mitral heart valves (Model 700 and S700) in sim when necessary to avoid anaromical obstruction

The CarboMedics Mirral Rotator is a one-piece, injection modeled rotator, manufactured from either blue polysulfone or blue polyetherimide. The CarboMedics Mitral Rotators are supplied non-sterile and must be cleaned and sterilized prior to initial use and each reuse. The reusable Carbo Medics Mitral Rotators are manufactured using a polysulfone or polyetherimide injection molding process. The CarboMedics Mitral Rotators are one-piece, hand-held instruments.