An Intramedullary Limb Lengthening Solution for the Amputee Patient

ELLIPSE

Ellipse Technologies, Inc., an innovative company focused on developing implantable technology to treat a broad spectrum of spinal and orthopedic applications, has developed a cutting-edge solution for residual limb lengthening of the femur. The FREEDOMTM Residual Limb Lengthening device is a unique telescoping intramedullary nail that utilizes a remote control to non-invasively lengthen the affected limb. FREEDOM was designed to minimize overall nail length while maximizing distraction potential.

FREEDOM Benefits:

•Eliminates the need for External Fixation

•Customizable Lengthening Protocol

•Novel Magnetic Telescoping Technology

•130 mm in Overall Length

•Up to 100 mm of Distraction

RESIDUAL LIMB LENGTHENING SYSTEM

FREEDOM

External Remote Controller (ERC)

Rx Only.The Ellipse FREEDOM™ Residual Limb Lengthening System is composed of an implantable intramedullary nail, locking screws, reusable instruments, and a hand-held External Remote Controller (ERC). The FREEDOM™ is a sterile single use device that is surgically implanted using the instruments and locking screws. The ERC is used daily after implantation to non-invasivelylengthen or shorten the implant to a prescribed length. The FREEDOM™ System is intended for lengthening of the residual limb of the femur. Contraindications include infection or pathologicconditions of bone such as osteopenia which would impair the ability to securely fix the device, metal allergies and sensitivities, patients whose distance from the surface of the treated limb to the intramedullary canal is greater than 51 mm, or other conditions that tend to retard healing such as blood supply limitations, peripheral vascular disease or evidence of inadequate vascularity, patients unwilling or incapable of following postoperative care instructions. The implantable device is only to be used by a trained licensed physician. Please refer to the FREEDOM™ Residual Limb Lengthening System instructions for use for complete Important Safety Information. Caution: Federal law restricts this device to sale by or on the order of a physician. This product, and the use thereof, maybe covered by one or more of the following U.S. and/or international patents: US 7,981,025, US 8,057,472, US 8,197,490, US8,343,192, US 8,382,756, US 8,419,734, US 8,449,543, US 8,715,159, US 8,734,488, US 8,808,163, CN 101917918, EP 2,114,258. Other U.S. and international patents pending. This product is licensed to the customer for single use only. Any resterilization or subsequent re-use is an unlicensed use and therefore constitutes patent infringement. ©2014 Ellipse Technologies, Inc. All rights reserved. RLL is a Trademark of Ellipse Technologies, Inc. LC0102-A

Ellipse Technologies, Inc. | 13900 Alton Parkway, Suite 123 | Irvine, CA 92618 Phone: (+1) 949-837-3600 | Fax: (+1) 949-837-3664

STATE-OF-THE-ART TECHNOLOGY

The key to the Ellipse platform technology is the magnetic interaction between the FREEDOM intramedullary (IM) nail and remote control. The proprietary technology includes a complex internal gear system remotely activated and controlled by permanent magnets.

The FREEDOM device combines an established magnetic technology with a novel telescoping design. This enables a compact 130 mm device the ability to distract up to 100 mm. This advancement in limb lengthening technology eliminates the need for external fixation, offers a precision-controlled distraction phase and allows the surgeon to non-invasively customize treatment.

R E S I D U A L L I M BL E N G T H E N I N G S Y S T E M

FREEDOM

EXTERNAL REMOTE CONTROLLER (ERC)

The ERC is a portable, hand held unit that precisely lengthens or shortens the IM nail through the touch of a button. The ERC is fully customizable to each patient based on their distraction needs. The ERC is designed to be used in a clinical setting or the comfort of the patient’s home.

NailApproach

ModelNumber

Drill GuideConfiguration

MaximumDistraction (mm)

OverallLength (mm)

Antegrade/Retrograde R14-100A130100 130

ELLIPSE

For more information about this exciting technology, please visit our website at www.ellipse-tech.com or contact your local sales representative.