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DesignNewswire · COMO, Italy ·

Additive Implants Inc. Receives the Bronze A' Design Award for SureMAX Cervical Implant in Medical Devices and Medical Equipment Design

Additive Implants Inc. recognized for medical devices and medical equipment design by the international grand jury of the 2019 - 2020 A' Design Award & Competition

FOR IMMEDIATE RELEASE

COMO, Italy, April 22, 2020 /DesignNewswire/ A' Design Award & Competition has confirmed the Bronze A' Design Award in the Medical Devices and Medical Equipment Design category for SureMAX Cervical Implant by Additive Implants Inc., designed for Additive Implants Inc. The award was conferred within the 2019 - 2020 A' Design Award & Competition and was determined through blind peer review by an international grand jury panel of established academics, design professionals and press members, who scored anonymized entries against predetermined criteria.

About the Bronze A' Design Award

The Bronze A' Design Award is given to outstanding designs that showcase a high degree of creativity and practicality. It recognizes the dedication and skill of designers who produce work that stands out for its thoughtful development and innovative use of materials and technology. These designs are acknowledged for their professional execution and potential to influence industry standards positively. Winning this award highlights the designer's ability to blend form and function effectively, offering solutions that enhance people's lives and wellbeing.

About SureMAX Cervical Implant

SureMAX is a titanium cervical spinal implant used in anterior cervical discectomy and fusion surgery. The stiffness of SureMAX is matched to the stiffness of the patient bone, so the vertebra is not damaged and the implant does not settle. Bone grows well into titanium, yet earlier titanium cages were too stiff. SureMAX is produced by three-dimensional printing from titanium powder, which allows geometries that cannot be machined. The surface is porous and roughened to support bone growth. Side windows allow healing to be seen on X-ray images.

Award Record

With this recognition, Additive Implants Inc. is a winner of 1 A' Design Award.

About the A' Medical Devices and Medical Equipment Design Award

The A' Medical Product Design Award is an international design competition recognizing good medical product designs by best brands and manufacturers worldwide. It is organized within the A' Design Award & Competition and is open to medical product designers, medical equipment manufacturers, biomedical engineers and medical device brands from all countries. Typical entries include stethoscopes, wheelchairs, defibrillators, MRI machines, surgical instruments and prosthetics. The awarded medical product designs are published at https://dezigners.org/design-category/medical-product

About A' Design Award & Competition

Organized annually since 2008, A' Design Award & Competition is an international, juried design accolade. The competition is open to entries from all countries. The philanthropic mission of the A' Design Award is to advance society through good design, by recognizing and promoting superior products, projects and services that benefit society, and by creating a global awareness and appreciation for good design practices and principles. Nominations are peer reviewed and evaluated anonymously by an international grand jury panel of established academics, design professionals and press members against predetermined criteria such as functionality, ergonomics, engineering, presentation, innovation, usability, sustainability and technology, with score normalization applied to remove biases. Awards are conferred at Platinum, Gold, Silver, Bronze and Iron levels. Eligible laureates receive the A' Design Prize, which includes the award trophy, the certificate of design excellence, the hardcover yearbook, a lifetime license to use the A' Design Award winner logo, exhibition of awarded works, an invitation to the gala night and award ceremony in Italy, inclusion in the World Design Rankings and Designer Rankings, and public relations and publicity services. Registration, uploading a work and receiving a preliminary score are free of charge, and Professional and Digital Edition laureates are not contractually obliged to pay further fees to claim the A' Design Prize. More information is available at https://competition.adesignaward.com

Press Resources

Media Contact

Giulia Ferrari, Press Office
Designers.Org
Via Leone Leoni 32, 22100 Como, Italy
press@designers.org
+39 031 4491953

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Fact Sheet

The Work

Project
SureMAX Cervical Implant
Function
Cervical Implant
Category
Medical Devices and Medical Equipment Design
Discipline
Industrial Design
Industry
Health
Colors
Rosy Brown, Silver, Gray, Light Gray and Dark Gray
Images
3
Client
Additive Implants Inc

The Recognition

Laureate
Additive Implants Inc.
Country
United States of America
Recognition
Bronze A' Design Award
Edition
2019 - 2020
Design ID
#88502

Credits

Team
Dr. John Ehteshami MD, Robert Brosnehan, Matt Zoghi, JD Howell, Jeff Horn and Babak Ehteshami

Design Details

Unique Properties
SureMAX is the first Titanium spinal implant that has a stiffness that matches the individual's bone stiffness as not to damage it. Bone loves to grow into Titanium but Titanium cages have been limited because they are too stiff and damage the bone. SureMAX has solved this problem through using 3D print technology with geometries that are not machinable. It also has a porous roughen surface to encourage bone to grow into it.
Inspiration
The inspiration was the lack of a solution that took advantage of new geometries that can be created with Titanium which is the best material for bone to grow into by a spine surgeon who performs over 300 cervical surgeries a year. He wanted an implant made from Titanium that matched bone's hardness, not to damage the vertebra, was visible in X-rays, so healing could be seen through, and would not subside in the spine.
Research
Titanium (Ti) has always been the material of choice for implants. But Ti is hard to machine and is very stiff. In the interface between Ti and bone, bone can be damaged and the implant subside ( or settle ) in the body. Plastic and Allograft bone material implants are used to address Ti's limitations. Additional, Ti is not X-ray translucent, so physicians can not see how the bone heals through and around the implant. Plastic implants also have the limitation that they remain inert in the body- they are never adsorbed. Bone however grows very well into Ti.
Challenge
To get result required- a high performance implants which is cost competitive, the team had to design a part that could both hand the stresses and forces required by the US government FDA while solving the patient challenges. The part had to be designed so minimal post processing would be required after 3D printing. Additionally, the rough porous surface which helps the healing process required advance software and new methodologies to manufacture. The diving boards had to share the spinal loads equally in order not to displace the implant in the spine. Side windows had to be designed that permits the loads to be distributed and have large have enough surface to see the bone healing.
Realization and Technology
3D print technology has been used with Titanium powder (Ti6Al4) using porous surface technology to achieve designs that will encourage bone to grow into the spinal implant
Operation and Interaction
The implant is used in an Anterior Cervical Discectomy Fusion (ACDF) surgery where the front of the neck is opened, the damaged cartilage removed and an implant is inserted in order to fuse the vertebra. The implant comes in a sterile plastic package. The surgeon once the damage is observed and removed assesses the size required. The appropriate implant size, angle and foot print is selected and inserted into the spine. A plate is then used (not part of SureMAX) to attach the upper and lower vertebra. The bone then grows into the implant (called inter body fusion device IBFD) and the patient heals.
Project Duration and Location
The design started in 2015 and ended in October 2018 and FDA approval was received in February 2019 (3 year design and 4 month approval). The work was done in Phoenix Arizona USA.
Specifications
There are 72 sizes for SureMAX. The height, the foot print and the angle of the implant are the 3 choices. The angles are 0, 7 and 14 degrees. The choice of the angle is used to correct any stenosis in the spine (this is when the spine has a deformity and the implant is used to fix it). The heights are 5,6,7,8,9,10,11 and 12 mm. The foot prints are 12x14 mm, 14x16 mm and 15x118mm. All units come in a sterile plastic package.
Keywords
spinal implant, Inter body fusion device, IBFD, cage, Titanium, Ti Cage, 3D printed, Spine

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