Wednesday, March 23, 2005

Essure Permanent Birth Control System

Filed under: Ob/Gyn

Conceptus Inc. has received the 2005 Gynecological Surgical Devices Enabling Technology of the Year Award by Frost & Sullivan for its permanent birth control system Essure.

From the official website:

The Essure permanent birth control system is designed to provide a non-incisional alternative for women seeking sterilization. By offering Essure to your patients, you will be using breakthrough technology which has overcome the historic obstacles to hysteroscopic sterilization.

How It Works
Using a hysteroscopic approach, one Essure micro-insert is placed in the proximal section of each fallopian tube lumen. The micro-insert expands upon release, acutely anchoring itself in the fallopian tube.

The micro-insert subsequently elicits a benign tissue response. Tissue in-growth into the micro-insert anchors the device and occludes the fallopian tube, resulting in sterilization.

In clinical trials, Essure was 99.80% effective after three years of follow-up and women were back to their regular activities, typically in 1- 2 days.

Components
The Essure permanent birth control system consists of the Essure micro-insert, a disposable delivery system, and a disposable split introducer.

A standard hysteroscope with a 5 French working channel, continuous flow, and a 12-30 degree angled lens is used in concert with Essure.

The Micro-Insert
The Essure micro-insert consists of a stainless steel inner coil, a nitinol, super-elastic outer coil, and polyethelene (PET) fibers. The PET fibers are wound in and around the inner coil. The micro-insert is 4 cm in length and 0.8 mm in diameter in its wound down configuration. When released, the outer coil expands to 1.5 to 2.0 mm to anchor the micro-insert in the varied diameters and shapes of the fallopian tube.

The Essure micro-insert in expanded state at the distal end of the delivery system. The micro-insert is soft, flexible, and form-fitting.

Disposable Delivery System
The disposable delivery system consists of a single-handed ergonomic handle, which contains a delivery wire, release catheter, delivery catheter, and micro-insert.

The ergonomic handle controls delivery and release. A thumbwheel on the handle allows the physician to retract both the delivery catheter and the release catheter. The delivery wire is detached from the micro-insert by rotating the system.

The split introducer helps protect the micro-insert as it passes through the rubber port of the hysteroscope working channel.

More at Conceptus, plus at the official product page...

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