Medacta International Adds Mpact 3D Metal Implants and Augments to Mpact System for Primary Hip Replacement and Revision Surgeries

October 11, 2018

CASTEL SAN PIETRO, Switzerland–(BUSINESS WIRE)–Medacta® International, the privately owned, global leader in innovative joint replacement and spinal technologies, today announced it has received clearance from the U.S. Food and Drug Administration (FDA) for the Mpact 3D Metal™ Implants and Augments 3D Metal as enhancements to its Mpact® System for primary to complex hip revision procedures. The first stateside surgery utilizing the implant and augments was performed this summer by Tyler Goldberg, M.D., of Austin-based Texas Orthopedics, Sports & Rehabilitation Associates.

The new implants, Mpact 3D Metal Acetabular Two-Hole and Multi-Hole Shells, are hemispherical porous shells with multiple highly cross-linked polyethylene liner options. The implants’ ultra-porous material makes them ideal for more demanding primary patient cases or to address difficult revisions with compromised bone. They are complemented by the porous 3D Metal Augments, designed to act as a defect-filling implant in cases of severe bone loss to help increase implant stability. The augments come in a variety of shapes and sizes, giving surgeons intraoperative flexibility to address a wide variety of acetabular defects. Together, these additions strengthen Medacta’s Mpact System and provide surgeons with more options when addressing complex primary hip replacements, as well as revisions.

Dr. Goldberg’s primary case utilized the Mpact Two-Hole Shell. “I was impressed with how firm the Mpact 3D Metal Implant was upon initial impaction. The shell has exceptional grip, making primary fixation easy and solid,” Dr. Goldberg said of his experience. “Knowing the shell is of high porosity and solid nature gave me great confidence for durable bone ingrowth, and my patient is recovering very well.”

The Mpact 3D Metal Implants feature Medacta’s proprietary 3D Metal technology, constructed via additive manufacturing performed by a 3D printer. The result is enhanced initial stability due to a high coefficient of friction at the bone interface and favorable environment for bone without the need for an additional coating. The 3D Metal Shells and Augments have pore sizes of 600-800 micrometers and continuously interconnected open pores with a high-porosity level of 75 percent.

“Medacta continues to expand upon its product portfolios as we seek to help our surgeon partners address more patient cases than ever before, whether it’s a complex primary case or a difficult revision,” said Francesco Siccardi, Executive Vice President of Medacta International. “With the new Mpact 3D Shells and 3D Metal Augments, our Mpact System offers even greater versatility and continues to instill confidence, thanks to both the high-grade materials used and the built-in surgeon education and support system for which Medacta is well known.”

The Mpact 3D Metal Implants and Augments are compatible with several surgical techniques, including Medacta’s Anterior Minimally Invasive Surgery (AMIS®) approach to hip replacement. The muscle-sparing AMIS approach is supported by the Medacta Orthopaedic Research and Education (M.O.R.E.) Institute, which provides surgeons with educational resources, training and mentorship as well as dedicated tools and instruments as they transition and practice the technique.

For more information, visit Medacta’s Mpact System webpage.

About Medacta International

Medacta® International is a world leading company, developer and supplier, specializing in joint replacement, spine surgery, and sports medicine solutions. Medacta’s revolutionary approach and responsible innovation, focusing on Minimally Invasive Solutions and Personalized Medicine, have resulted in standard of care breakthroughs in hip replacement with the AMIS® system and total knee replacement with MyKnee® patient matched technology. Medacta has grown dramatically by taking a different approach and placing value on all aspects of the care experience from design to training to sustainability. Medacta is headquartered in Castel San Pietro, Switzerland, operates in over 30 countries around the globe, and employs more than 930 people. To learn more about Medacta International, please visit www.medacta.com or follow @Medacta on Twitter and LinkedIn.

Contacts

For Medacta International
Jill Bongiorni, 516-729-2250
Jill@torchcomllc.com

SpineEX® Announces FDA Clearance of Sagittae® Lateral Lumbar Interbody Fusion Devices

FREMONT, Calif.Oct. 10, 2018 /PRNewswire/ — SpineEX, Inc., a medical device company that aims to provide innovative and minimally invasive implants, high-value disposables and instrumentation for spinal fusion surgeries, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Sagittae lateral lumbar interbody fusion (LLIF) device.

The LLIF procedure uses minimally invasive techniques that approach the spine from the side of the patient, allowing for a larger implant footprint, and less disruption to lower back muscles as compared to other approaches, which results in less blood loss and faster recovery.

Sagittae is a personalized, adjustable expandable LLIF device designed to minimize impaction, maximize indirect decompression, and provide a large graft space optimal for lumbar fusion procedures. It is designed for up to 8mm of continuous in situ expansion, with up to 30° of continuous in situ lordotic adjustment. The large single graft chamber can be filled with bone graft material after insertion and adjustment to ensure even contact with both vertebral endplates.

The ability to personalize the device to each patient’s needs provides restorative independent height and lordotic angle with proper anatomical fit. Available in five sizes, all with independent parallel height or lordotic profiles, Sagittae provides several options for surgeons to address optimal sagittal balance, while minimizing burdensome implant inventory traditionally required for each procedure.

“Sagittae is a personalized, expandable spinal implant with intra-operative adjustability ability for any height and any lordotic angle needed in a patient’s specific anatomy. This new lateral cage minimizes the need to forcefully impact the cage into the disc space,” said Roy Chin, Executive Chairman and CEO of SpineEX.

Indications for Use 
The SpineEX Sagittae Lateral Lumber Interbody Fusion Devices are indicated for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. Supplemental fixation is required with SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices. Additionally, the SpineEX devices are intended to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.

About SpineEX, Inc. 
SpineEX is a medical device company that is focused on providing minimally invasive implants, high-value disposables and instrumentation for spinal fusion surgeries.

SOURCE SpineEX

First Endoscopic Minimally Invasive Spinal Procedure at Reston Hospital Center is Performed by Surgeons at Virginia Spine Institute

RESTON, Va., Oct. 10, 2018 (GLOBE NEWSWIRE) — Dr. Colin Haines, assisted by Dr. Christopher Good, Spine Surgeons at Virginia Spine Institute, is the first physician to perform endoscopic spine surgery at Reston Hospital Center. Through a micro incision (less than 1cm), Dr. Haines and Dr. Good utilized the magnification of an HD-endoscope to perform a microdiscectomy. This surgical method allowed safer and more efficient removal of a disc herniation.

Minimally invasive procedures are now commonplace in spinal surgery, but endoscopic spine surgery utilizes ultra-minimally invasive technology that enhances traditional surgical technique. The advantage of a smaller incision (less than 1cm) and the introduction of a high-resolution camera minimizes tissue disruption and reduces post-operative pain for the patient. Typically performed as an outpatient procedure, patients undergo less anesthesia and experience improved recovery times.

A wide-reaching innovation, endoscopic spine surgery has promise to transform the lives of patients with degenerative disc disease, disc herniations, and spinal stenosis. This milestone is an essential breakthrough for future spinal procedures as the specialists at Virginia Spine Institute work to advance endoscopic technology for spinal fusions and spinal decompressions.

“Endoscopic spine surgery has unleashed new potential for faster, safer, and more effective surgical recoveries,” says Dr. Colin Haines, Spine Surgeon and Director of Research at Virginia Spine Institute“I’m proud to dramatically improve the lives of patients suffering from back pain by pioneering treatment solutions like this that get them back to their active lifestyles faster.”

Dr. Colin Haines is an expert in minimally invasive surgical techniques that improve patient safety and reduce recovery time. These techniques include ultrasonic spine surgery, endoscopic spine surgery, and robot-guided spine surgery.

Dr. Christopher Good, Spine Surgeon and President of Virginia Spine Institute, specializes in the treatment of complex spinal conditions and is considered a world expert in the field of robotic spine surgery.

About Virginia Spine Institute: Virginia Spine Institute is an award-winning specialty medical practice in the Washington, DC metro area solely dedicated to spinal health care. For over 25 years they have improved the lives of over 85,000 patients suffering from back or neck pain conditions. This comprehensive spine center provides convenience of specialty care with the top experts from multiple specialties of spinal health care under one roof. Custom treatment options include non operative care, pain management, physical therapy, and when necessary surgical intervention, including minimally invasive, laser and robot-guided procedures. For more information about Virginia Spine Institute visit SpineMD.com.

Photo accompanying this announcement are available at

http://www.globenewswire.com/NewsRoom/AttachmentNg/71cbbbb0-a542-4be7-9ca8-c8047319cddf

http://www.globenewswire.com/NewsRoom/AttachmentNg/b8e761d3-ef29-4ea3-acb7-c71cdc88752b

Contact: Communications Director
Virginia Spine Institute
Tel: 703.709.1114 x 180
Email: 
SpineMD.com

Medovex Corporation Names William E. Horne Chief Executive Officer and Chairman of the Board

ATLANTA, Oct. 09, 2018 (GLOBE NEWSWIRE) — Medovex Corp. (OTCQB: MDVX), (“Medovex” or the “Company”), the developer of the DenerveX® System, a new and novel device designed for enduring relief of Facet Joint Syndrome related to chronic back pain, a non-addictive, non-opioid drug alternative capable of restoring a patient to a more normal and active lifestyle, today announced that it has named William “Bill” Horne as the Company’s Chief Executive Officer and Chairman of its Board of Directors.

Bill Horne is a founder and former Chief Executive Officer and Chairman of the Board of Laser Spine Institute. From 2005 to 2015, Horne served as the company’s CEO, expanding the homegrown organization from one facility with nine employees, to seven state-of-the-art surgery centers with more than 1,000 employees across six states, while driving annual revenues as high as $288M during his tenure. In his role as Chairman of the Board, he led the strategic direction of the company, which has made it possible for more than 75,000 patients to take back their lives from chronic pain with its minimally invasive spine procedures.

Horne’s desire to found and cultivate Laser Spine Institute was derived from an extremely personal place, his own experience. Horne himself suffered from chronic back pain before having his own minimally invasive spine surgery. That experience drove him to found Laser Spine Institute. He believed in creating a company that offered relief from chronic neck and back pain coupled with a superior patient experience.

Bill Horne stated, “I’m excited to join Medovex at what I view as an opportunistic time. I’ve long felt that the Company’s DenerveX System represented a highly disruptive longer-term solution to chronic lower back pain associated with the Facet Joint, a sizeable market opportunity that continues to see large growth. Importantly, it’s a market I’m intimately familiar with, having been one of the founders of Laser Spine Institute.”

Horne continued, “My initial goal as CEO of Medovex will be to immediately pursue both synergistic and accretive opportunities that have the potential of achieving near-term greater scale, while best positioning us to leverage that increased scale with the intent of unlocking and maximizing the true value of the DenerveX System. I look forward to hitting the ground running and executing our plan, solely focused on building measurable shareholder value.”

Jarrett Gorlin, Medovex’s outgoing Chief Executive Officer, stated, “Bill’s proven track record as a leader in multiple industries including healthcare speaks for itself. To say we are excited to have attracted such a highly accomplished CEO and Chairman would be an understatement. Our entire management team and board of directors is confident in Bill’s vision, experience and track record of building enterprise value. Together we believe the decision to name him our new CEO and Chairman is in the best of interest of our shareholders.”

About Medovex

Medovex was formed to acquire and develop a diversified portfolio of potentially ground breaking medical technology products. Criteria for selection include those products with potential for significant improvement in the quality of patient care combined with cost effectiveness. The Company’s first pipeline product, the DenerveX System, is intended to provide long lasting relief from pain associated with facet joint syndrome at significantly less cost than currently available options. To learn more about Medovex Corp., visit www.medovex.com.

Safe Harbor Statement

Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Medovex believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the company’s filings with the U.S. Securities and Exchange Commission. Thus, actual results could be materially different. Medovex expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

CONTACT INFORMATION

  • Medovex Corp.
    Jason Assad
    678-570-6791
    Jassad@medovex.com

OrthoSensor Announces Milestone Of 50,000 VERASENSE Sensors Distributed Globally

Implanet UK announces its first surgery in the United Kingdom

October 04, 2018

BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:

Implanet (Paris:ALIMP) (OTCQX:IMPZY) (Euronext Growth: ALIMP, FR0010458729, eligible for PEA-PME equity savings plans; OTCQX: IMPZY), a medical technology company specializing in vertebral and knee surgery implants, announces the completion of its first surgery in the United Kingdom via Implanet UK, at the Royal Orthopaedic Hospital of Birmingham, following the opening of its branch in early June1.

The recent listing of Implanet UK and its Jazz® platform on the NHS (National Health Service), the United Kingdom’s public health system providing the bulk of care, particularly in hospitals, allows Implanet UK to offer Jazz® to all public hospitals in the country.

As a reminder, the United Kingdom is the second largest market in Europe for spinal fusion back surgery. The potential in adult degenerative spine disease is estimated at over $100 million2.

Next press release: 3rd quarter 2018 revenue on October 9, 2018 before the market opens.

About IMPLANET

Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ® latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ® has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 46 staff and recorded 2017 sales of €7.8 million. For further information, please visit www.implanet.com. Based near Bordeaux in France, IMPLANET established a US subsidiary in Boston in 2013. IMPLANET is listed on Euronext™ Growth market in Paris. The Company would like to remind that the table for monitoring the BEOCABSA, OCA, BSA and the number of shares outstanding, is available on its website: http://www.implanet-invest.com/suivi-des-actions-80

1 IMPLANET announces opening of a United Kingdom sales branch
2 Mordor Intelligence 2017 study

Contacts

IMPLANET
Ludovic Lastennet, +33 (0)5 57 99 55 55
CEO
investors@implanet.com
or
NewCap
Investor Relations
Julie Coulot, +33 (0)1 44 71 20 40
implanet@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau, +33 (0)1 44 71 94 98
implanet@newcap.eu
or
AlphaBronze
US-Investor Relations
Pascal Nigen, +1-917-385-21 60
implanet@alphabronze.net

SI-BONE, Inc. Announces that NICE, the UK Nat’l Institute for Health and Care Excellence, Published Medical Technology Guidance Supports iFuse for Treatment of Sacroiliac Joint Pain

Trice Medical Launches the World’s First Dynamic Imaging Platform, Adding Ultrasound Capability to the mi-eye®

MALVERN, Pa.Oct. 2, 2018 /PRNewswire/ — U.S. based Trice Medical, Inc. announced today the launch of its latest product, mi-ultra™, a high powered 15mHz handheld ultrasound transducer. The mi-ultra™ is enabled by the same platform technology that Trice’s flagship product, mi-eye 2®, operates on, the mi-tablet.

The mi-ultra™, which comes in both convex and linear offerings, has been optimized for Muscular Skeletal (MSK) applications. The addition of this technology to Trice’s Dynamic Imaging Platform will enable orthopedic practices to provide a full suite of MSK imaging at the first point of care. The ability to provide a dynamic evaluation for patients, as opposed to static systems like MRI and X-Ray, has never been easier for orthopedic offices with this all-in-one portable system.

Dr. Don Buford, orthopedic surgeon and founder of the Dallas PRP and Stem Cell Institute, said, “The mi-ultra™ is a combination of the first MSK ultrasound system with sufficient image quality and reliability for all diagnostic and procedure indications with the first tablet based disposable office needle arthroscopy platform. Now, every orthopedic clinician can have a single portable tablet for imaging intra-articular and extra-articular anatomy for diagnosis and procedures. This is a truly revolutionary point of care imaging system and the only such platform available!”

The early success of Trice Medical’s mi-eye 2®, which was launched in the U.S. in 2017, has captured the attention of medical professionals who are embracing the technology as a new diagnostic modality. After the first year of commercial launch, the mi-eye® is currently being used by over 300 institutions across the U.S. The disposable needle embedded with a wide-angle camera lens enables physicians to diagnose joint injuries right in their clinic; deliver biological under direct visualization; and provide their patients with immediate answers to the cause of their pain.

“This is a truly disruptive technology for the orthopedic industry,” said Mark Foster, President and CCO of Trice Medical. “Today’s healthcare environment is asking for innovation in a cost-effective manner. Trice is proud to have combined an arthroscopy tower and a high-powered ultrasound system into one simple, portable tablet. The disposable mi-eye 2®camera is great to identify pathology within the joint and the mi-ultra is a perfect complement for guided injections or assessing soft tissue damage outside of the joint. We believe the system is a “must have” for every orthopedic practice.”

About the mi-eye 2®:

Trice Medical’s mi-eye 2® is a handheld, single-use, and disposable direct visualization tool. The mi-eye 2® was specifically designed for use in the clinic setting, consisting of a single stick percutaneous, and self-blunting design which deploys an integrated camera and a light source. The procedure is performed with local anesthetic and provides patients with an alternative to traditional diagnostic modalities, such as time-consuming and often inaccurate MRIs. The mi-eye® is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. The mi-eye 2® is available for prescription use only.

About Trice Medical:

Trice Medical was founded to fundamentally improve orthopedic diagnostics for the patient, and the physician providing instant answers. Trice Medical has pioneered fully integrated camera-enabled technology, the mi-eye 2®, that provides a clinical solution optimized for the physician’s office. Trice Medical’s mission is to provide more immediate and definitive patient care, eliminating the false reads associated with current indirect modalities and significantly reduce the overall cost to the healthcare system.

Contact Trice Medical:

+1 (610) 989-8080

info@TriceMedical.com

Trice Medical’s mi-eye 2

Related Links

Trice Medical

SOURCE Trice Medical

Related Links

https://tricemedical.com/

Solvay’s Ixef® PARA offers alternative to stainless steel in Innovative Surgical Designs’ new Redi-Spine™ system for spinal fusion surgical procedures

Alpharetta, Ga., October 2, 2018  Solvay, a leading global supplier of specialty polymers, announced during NASS 2018 last week that Innovative Surgical Designs, a developer and manufacturer of orthopedic spinal systems, chose Ixef® polyarylamide (PARA) resin to innovate a new single-use surgical instrument kit for minimally invasive spinal fusion surgery. Innovative Surgical Designs’ new Redi-Spine™ kit leverages Ixef® PARA’s mechanical strength, moldability and gamma sterilizability to offer an economical alternative to reusable stainless steel instruments.

Ixef® PARA’s metal-like strength and rigidity enabled us to simplify and deliver Redi-Spine™ instruments in a compact, elegant kit,” explained Jon Rinehart, chief financial officer of Innovative Surgical Designs. “When we first started heading down the path of polymer instruments, I candidly admit that I was skeptical. I didn’t think an injection-molded alternative to stainless steel was possible. But when we started working with Solvay’s Ixef® PARA resin, I realized how wrong I was.  We wouldn’t be able to offer the Redi-Spine™ kit for all of our surgeons’ one- and two-level cases without Solvay’s high-performance polymer and application support.

Designed to withstand the severe torsional forces and rigors of thoracolumbar spinal fixation, Innovative Surgical Designs’ Redi-Spine™ instruments received 510(k) clearance from the U.S. Food & Drug Administration (FDA) in August. It contains multiple disposable, handheld instruments including a T-ratchet handle, counter-torque tool and gearshift probe that are molded entirely or in part from Solvay’s Ixef® GS-1022 PARA.

Ixef® GS-1022 PARA can be sterilized with gamma ray radiation without any significant change to its mechanical properties, ultra-smooth finish or color. Solvay offers the material in a range of gamma-stabilized colors, from which Innovative Surgical Designs, Inc. chose gray for its kit. Solvay’s polymer has also been evaluated for ISO 10993 limited duration biocompatibility and is supported by an FDA Master Access File, which can help streamline regulatory approvals.

The growing adoption of single-use surgical instruments has increasingly established Solvay’s Ixef® PARA as a mainstream material for these applications,” said Jeff Hrivnak, business manager for Healthcare at Solvay’s Specialty Polymers Global Business Unit. “We continue to build on our early and proactive support of this trend by working closely with trailblazers like Innovative Surgical Designs, Inc. to help optimize their products for molding and speed to market.

Innovative Surgical Designs plans to launch the Redi-Spine™ kit during the fourth quarter of 2018. For more related news about specialty polymers for healthcare, please go to www.solvayhealthcarenews.com.

® Ixef is a registered trademark of Solvay
™ Redi-Spine is a trademark of Innovative Surgical Designs

 

Lambda Technologies Extends the Life of Orthopedic Implants

Lambda Technologies has developed a surface treatment for modular orthopedic implants that eliminates the chance of failure from fretting fatigue. Low plasticity burnishing (LPB®) applies a deep, beneficial surface layer of designed residual compression to mitigate fretting fatigue in titanium implants. By putting the edge of contact region in high residual compression much deeper than the shallow shear cracks formed by fretting, the cracks cannot propagate and the chance of fracture from fretting is eliminated.

Millions of people have regained their mobility because of hip or knee implant technology. Day- to-day activities of the implant recipient, particularly those who are active, can lead to repeated metal-to-metal sliding contact in the joint, leaving the implant vulnerable to fretting induced fatigue cracks and, potentially, failure in the edge-of-contact region. If failure does occur, revision surgeries are required, significantly affecting the quality of life of patients. Fatigue testing of the modular hip and knee prosthesis systems by original manufacturers showed that LPB treatment improves the baseline fatigue strength by nominally 40%, and completely eliminated the occurrence of fretting induced failure.

The FDA has approved Lambda’s LPB process for extending the life of modular prostheses. During the twelve-plus years that orthopedic surgeons have been using LPB treated hip implants, and approximately three years of LPB treated knee implants, no LPB processed implant has failed from fretting fatigue. Dr. N. Jayaraman, Director of Materials Research for Lambda Technologies noted that, “The cost savings and improvement in the quality of life for patients is immeasurable. And as an added bonus, the ease of implementation of LPB into existing production environments in CNC mills or lathes has made it very cost-effective for the manufacturers.“

Lambda Technologies is an innovative company incorporating a premier materials research laboratory with a world-class engineering and production enterprise dedicated to the development and optimization of surface treatments to improve component performance. For additional information on Lambda Technologies or the LPB process, contact Julie Prevéy at (513) 561-0883 or visit http://www.lambdatechs.com.