Friday, May 29, 2015
News: Dymicron, Inc., Announces the First Human Implantation of their Triadyme-CTM Cervical Total Disc Replacement Device in Cyprus
May 28, 2015
Orem, UT—Dymicron, Inc., (dymicron.com) confirmed the successful completion of their first in-human surgeries using their unique Triadyme-C cervical total disc replacement device. The two surgeries were performed by noted surgeon Dr. William D. Smith at the American Institute of Minimally Invasive Surgery (AIMIS) in Cyprus.
“The patients are responding well to the implantation of the Dymicron devices,” said Dr. William D. Smith, Chairman of AIMIS Spine Center and Chief of Neurosurgery for the University Medical Center, Las Vegas, Nevada. “The Triadyme-C is unique in its composition and design, most notably for its diamond compact. This design may place Dymicron as a front runner in cervical TDR devices in a time when research has shown cervical TDR is often superior to fusion.”
The Triadyme-C is the flagship product of Dymicron, Inc., a company focused on designing, developing and commercializing medical devices leveraging their proprietary Orthopedic DiamondTM material.
Triadyme-C will address two immediate areas of concern in the total disc replacement field – minimizing wear debris generation and emulation of natural constrained motion in the spine.
Dymicron’s biocompatible Orthopedic Diamond material is made of polycrystalline diamond compact (PDC), one of the hardest and most durable substances known to man. With extreme durability and a low coefficient of friction, Triadyme-C resists the structural breakdown that can release dangerous wear debris into the body.
The proprietary tri-lobe technology developed by Dymicron features an articulation mechanism made of three spherical lobes seated within three non-congruent, spherical pockets. The motion of the three lobes within their associated pockets generates a smooth, gentle centering force that emulates the natural motion of the spine.
“We are extremely pleased that we have successfully completed our first in-man procedures. Based on our unique technology and design, we’re confident that the Triadyme-C will become a preferred option for patients suffering from cervical degenerative disc disease,” said Jeff Bennett, President of Dymicron.
Following the successful completion of the first in-human procedures, Dymicron is slated to begin three clinical studies in England, Germany and South Africa in Q3 of 2015.
Founded in 1997, Dymicron, Inc. is a privately-held company located in Orem, Utah. They are an innovation-based medical device company that focuses on the design, development, manufacturing and marketing of a new generation of orthopedic implant devices utilizing their proprietary biocompatible Orthopedic Diamond material. For additional information about Dymicron, please contact Angela Bailey, Vice President of Marketing at (801) 580-4049 or at abailey(AT)dymicron.com.
Published @ PRWeb
27 MAY 2015
It includes cervical cages, plates and cage-plates (TRYPTIK®), lumbar cages (JULIET® PLIF, TLIF, ALIF) and the renowned thoracolumbar osteosynthesis system, ROMEO®2. This enables Spineart to address 90% of the fast-growing Chinese market (DDD, trauma, and deformities).
Published @ Spinart
News: EOS imaging Announces CE Mark for kneeEOS, the first 3D Stereo-Radiographic Planning Software for Total Knee Arthroplasty
PARIS--(BUSINESS WIRE)--EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI), the pioneer in 2D/3D orthopedic medical imaging and associated solutions, today announced the CE mark of kneeEOS, the first 3D planning software for total knee arthroplasty (TKA) based on EOS bi-planar imaging. The Company will showcase the planning suite at the 16th European Federation of National Associations of Orthopaedics and Traumatology (EFORT) Congress, held May 27-29 in Prague.
kneeEOS is the second software offering powered by EOS images following hipEOS, which was CE Marked and FDA cleared in 2014. This 3D surgical planning platform is based on EOS’ low dose 3D images and technology from OneFit Medical, a company acquired by EOS imaging in late 2013. kneeEOS will initially be deployed as an online service to assist surgeons in patient’s leg alignment simulation in functional position, knee prosthesis selection, and placement simulation based upon 3D images generated by the EOS system.
Marie Meynadier, CEO of EOS imaging, said, “Leg alignment and component positioning are known to significantly influence surgical outcomes for total knee replacement. kneeEOS is the first and only 3D planning software for TKA in a functional weight bearing position. We are proud that our work has driven this new development and placed our Company at the leading edge of 3D surgical planning tool innovation that maximizes the potential of EOS’ technology for our surgeon users and their patients. Following the launch of hipEOS and our EOS 3D Service, kneeEOS marks the continued expansion of our cloud based services based on EOS unique images and associated patient datasets.”
The EOS® system provides full-body stereo-radiographic images of patients in functional positions, in both 2D and 3D. EOS exams require a radiation dose 50% to 85% less than Digital Radiology and 95% less than basic CT scans, as well as related software solutions. The new EOS Micro Dose option, recently cleared by the Food and Drug Administration, allows a further drastic step towards the ALARA principle (As Low As Reasonably Achievable) by bringing pediatric spine follow up exams at a dose level equivalent to a week of natural background radiation on Earth.
For further information about the Company or EOS®, the first full body, low dose 2D/3D imaging system, please visit http://www.eos-imaging.com/.
EOS imaging has been chosen to be included in the new EnterNext© PEA-PME 150 index, composed of 150 French companies and listed on Euronext and Alternext markets in Paris.
EOS imaging is listed on Compartment C of Euronext Paris
ISIN: FR0011191766 – Ticker: EOSI
Next press release: revenue for the 1st half of 2015, on July 20, 2015 (after market).
About EOS imaging:
EOS imaging designs, develops, and markets EOS®, an innovative medical imaging system based on technology that enabled George Charpak to win the Nobel Prize for Physics, as well as associated solutions. The Company is authorized to market in 48 countries, including the United States (FDA), Japan and the European Union (EU). As of December 31, 2014 the Group posted 2014 consolidated revenue of €20.1 million and employed 107 people including an R&D team of 39 engineers. The Group is based in Paris and holds four subsidiaries in Besançon (France), Cambridge (Massachusetts), Montreal (Canada) and Frankfurt (Germany), and offices in Singapore.
Anne Renevot, +33 (0)1 55 25 61 24
Antoine Denry/ Pierre Laurent, +33 (0)1 44 71 94 91
Financial communication and investor relations
The Ruth Group (US)
Calvin Allen, 646-536-7002
SAN CLEMENTE, Calif.--(BUSINESS WIRE)--VertiFlex®, Inc., a leading innovator of advanced minimally invasive interventions for spinal stenosis, announced today that the U.S. Food and Drug Administration (FDA) has issued a PMA Approval Order for the company’s Superion® Interspinous Spacer System, clearing the way for commercialization in the United States. The Approval Order follows a February FDA Advisory Panel vote that Superion® demonstrated safety, effectiveness, and a favorable risk benefit profile based on the results from a 470 patient, multi-center, prospective and randomized controlled IDE trial.
“Superion® has proven to be a safe, effective and least invasive solution for the treatment of spinal stenosis, in a mostly Medicare-aged population. Countless numbers of patients in the United States will now benefit from this important technological advancement.”
Superion® is indicated for moderate lumbar spinal stenosis, and is the least invasive motion preserving device in the category of interspinous spacers.
- Largest, most robust IDE device trial for moderate lumbar spinal stenosis
- Superion® demonstrated clinical success of >80% in all major components of the composite primary endpoint at 24 months, maintaining durability of effect through 36 months
- Superion® patients exhibited similar leg pain improvement, as measured by VAS, compared to published literature on open surgical decompression
- Healthcare economic data was captured, demonstrating Superion’s cost-effective equivalency to open surgical decompression
- Superion® has been successfully implanted in over 2,000 patients around the world, and will soon be available in the United States
“We are delighted with this PMA approval based on compelling level one evidence developed in the Superion® IDE Trial,” said Earl R. Fender, President and Chief Executive Officer of VertiFlex. “Superion® has proven to be a safe, effective and least invasive solution for the treatment of spinal stenosis, in a mostly Medicare-aged population. Countless numbers of patients in the United States will now benefit from this important technological advancement.”
Nick Shamie, MD, Professor & Chief, UCLA Orthopaedic Spine Surgery, and co-Medical Director for VertiFlex, commented: “As an early adopter of interspinous spacers, they have provided tremendous improvement for my patients suffering from lumbar stenosis. As a next-generation technology, Superion® offers the potential for even greater clinical benefit, with the least invasive indirect decompression possible, and the ability for patients to avoid traditional open spine surgery.”
About VertiFlex, Inc.
VertiFlex is a privately held medical device company dedicated to the advancement of minimally invasive solutions for the treatment of lumbar spinal stenosis, which is the leading cause of spinal surgery in the elderly. Founded in 2005 and headquartered in San Clemente, CA, VertiFlex has developed proprietary, minimally invasive technologies for performing both indirect and direct decompressions of the lumbar spine. These procedures fill the gap in the stenosis treatment continuum between conservative care and traditional spine surgery, providing new options for interventional spine physicians and less invasive options for traditional spine surgeons. To date, VertiFlex has compiled the largest, most rigorous body of device clinical evidence related to lumbar spinal stenosis.