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Thomas H. Lee, MD, Installed as AOFAS President

Posted On August 18, 2017 By OrthoSpineNews In Extremities, Top Stories /  

ROSEMONT, Ill., Aug. 17, 2017 /PRNewswire-USNewswire/ — Columbus area orthopaedic surgeon Thomas H. Lee, MD, has been elevated to president of the 2,200-member American Orthopaedic Foot & Ankle Society (AOFAS), the leading organization for lower extremity medicine and foot and ankle surgery. In addition to his role as president, Lee will serve on the Board of Directors of the Orthopaedic Foot & Ankle Foundation (The Foundation).

Lee will focus his one-year term on maintaining foot and ankle orthopaedic surgeons’ leadership in lower extremity care and on expanding educational and research opportunities to healthcare professionals in the US and internationally.

“The AOFAS represents the very best in orthopaedic surgery when we collaborate to learn, to teach, and to grow,” Lee said. “As healthcare evolves rapidly around us, the AOFAS will remain relevant to our members and responsive to the important issues they face.”

Lee earned his medical degree from Columbia University College of Physicians and Surgeons in New York City and completed his orthopaedic residency at the New York Orthopaedic Hospital at Columbia-Presbyterian Medical Center. He received his fellowship training in foot and ankle orthopaedic surgery at Thomas Jefferson University Hospital in Philadelphia.

Lee is a foot and ankle orthopaedic surgeon in private practice in Pickerington, Ohio. He is active in humanitarian outreach, having volunteered as a surgeon for the AOFAS Overseas Outreach Project to Vietnam, as well as projects in Afghanistan, Pakistan, and Haiti. A longtime member of the AOFAS, he has been a member and chair of numerous committees, served as president of The Foundation, and served for the last four years on the AOFAS Board of Directors.

About Foot and Ankle Orthopaedic Surgeons
Foot and ankle orthopaedic surgeons are medical doctors (MD and DO) who specialize in the diagnosis and treatment of musculoskeletal disorders and injuries of the foot and ankle. Their education and training consists of four years of medical school, five years of postgraduate training, and often a fellowship year of specialized foot and ankle surgical training. Foot and ankle orthopaedic surgeons treat patients of all ages, performing reconstructive procedures, treating sports injuries, and managing foot and ankle trauma.

About the AOFAS
As the professional organization of foot and ankle orthopaedic surgeons, the AOFAS promotes quality, ethical, and cost-effective patient care through education, research, and training of orthopaedic surgeons and other healthcare providers. The Society creates public awareness for the prevention and treatment of foot and ankle disorders and serves as a resource for government and industry as well as the national and international healthcare communities. For more information, visit www.aofas.org.

 

SOURCE American Orthopaedic Foot & Ankle Society

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http://www.aofas.org

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Nextremity Solutions, Inc. Announces Limited Release of the PiroVue™ Gastrocnemius Recession System

Posted On August 9, 2017 By OrthoSpineNews In Extremities /  

WARSAW, Ind., Aug. 8, 2017 /PRNewswire-iReach/ — Nextremity Solutions, Inc., a strategic commercialization organization with a focus on the musculoskeletal space, located in “The Orthopedic Capital of the World” Warsaw, IN, has announced the limited release of its newest product, the PiroVueTM Gastrocnemius Recession System for the treatment of equinus deformities in patients.

According to a report in the 2015 Podiatry Management publication by Patrick A Deheer, DPM entitled, “The Non-Surgical Treatment of Equinus”, equinus deformity has been associated with over 96% of biomechanically related foot and ankle pathologies. An equinus deformity is a condition that limits the bending motion of the ankle joint. A patient with this deformity lacks the flexibility to raise their foot up and has a tendency to apply too much pressure to the bones in the forefoot. Equinus deformity can contribute to foot problems such as plantar fasciitis, metatarsalgia, arthritis of the midfoot, bunions, hammertoes, and more.”

PiroVue is a disposable, single use, sterile packed instrument kit for gastrocnemius recession.  It consists of an integrated cutting guide and retractor with a controlled recession knife.

“We’re excited about the launch of PiroVue, a solution born from the frustration and ingenuity of our surgeons.  Our surgeons are passionate about this gastrocnemius recession procedure and the resulting benefits they’ve seen in their patients.  This disposable, efficient, and cost-effective solution for gastrocnemius and soleus recession will potentially result in less muscle atrophy and weakness, as well as early weight bearing, relatively shorter periods of cast immobilization, while reducing risks to the sural nerve.  Our hope is that PiroVue will allow for continued adoption and growth of this surgical procedure.” commented Ryan S. Schlotterback, Chief Commercialization Officer for Nextremity Solutions, Inc.

The patent-pending PiroVue Gastrocnemius Recession System will utilize a limited launch with key surgeons prior to a full commercial launch in Q1 2018.

Rod K. Mayer, President and CEO of Nextremity added, “Our goal as a part of our i3TMStrategic Solutions initiative is to continue to workwith surgeons to address their unmet needs in their respective surgical specialties.  Our passion for creating  innovative product solutions is to positively and significantly impact the lives of patients. If through the PiroVue Gastrocnemius Recession System patients can potentially get them back on their feet sooner with less issues, then we have succeeded.”

For more information or to schedule a demonstration of the PiroVue Gastrocnemius Recession System, please visit http://www.nextremity.com/pirovue.

About Nextremity Solutions, Inc.

Nextremity Solutions, Inc. is a privately held strategic commercialization organization with a focus on the musculoskeletal space, offering innovative solutions and Revenue Ready™ products for various musculoskeletal applications and for the benefit of our industry partners. The Company’s procedure-ready, sterile implant systems include uniquely precise, proprietary technology designed to achieve repeatable and superior clinical outcomes.

For further information, visit www.nextremitysolutions.com or call Dave Temple, Director of Marketing & Corporate Communications at 574-635-3022.

Media Contact: Dave Temple, Nextremity Solutions, Inc., 574-635-3022, dave.temple@nextremity.com

News distributed by PR Newswire iReach: https://ireach.prnewswire.com

 

SOURCE Nextremity Solutions, Inc.

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In2Bones USA Announces FDA Clearance on Two Key Implant Systems

Posted On August 9, 2017 By OrthoSpineNews In Extremities, Regulatory /  

August 08, 2017

MEMPHIS, Tenn.–(BUSINESS WIRE)–In2Bones Global, Inc. today announced that its In2Bones USA, LLC subsidiary has received U.S. Food and Drug Administration (FDA) clearance for its new Fracture and Correction System. The System will be marketed under the 5MS™ Fracture Repair System and the CoLag™ Locking Compression Screw System brand names.

The 5MS Fracture Repair System is a comprehensive plate and screw system that addresses both fractures and deformities of the 5th metatarsal bone (5thtoe) of the foot. Unlike competitive systems, the 5MS System features an array of anatomically contoured plates and fracture-specific screws that provides surgeons more options to customize the needed repair.

The new System offers surgeons multiple design and performance improvements compared with traditional plate products, plus the versatility of interchangeable screws and plates, and specially designed surgical instruments – all to enhance surgical technique and treatment efficacy.

“Fractures of the 5th metatarsal are the most common in athletes of all skill levels. The 5MS™ System’s unique plantar fracture plate design may address many of the healing complications seen from other methods of treatment,” says Kevin Varner, M.D. of Houston Methodist Orthopedics and Sports Medicine.

The CoLag Locking Compression Screw System is an entirely new concept in orthopaedic bone fixation. Differential, dual-pitch screw threads combined with a low-profile head create a compression lock between the bone fragment and fracture, significantly improving compression compared with competitive headless screws.

“Bone fragment stability and compression are important factors in healing. The CoLag System creates the compression of current headless screws while offering the stability, fixation and ease of removal of screws with heads,” says Keith Heier, M.D., Past President of OrthoTexas Orthopedics & Sports Medicine. “This design may be one of the most significant advances in screw fixation in the past 25 years.”

As is true with all In2Bones USA products, the 5MS and CoLag implants are delivered in individual, pre-sterilized packaging, and are UDI compliant and fully traceable.

The past twelve months have been busy for the company. In August 2016, In2Bones USA, LLC and In2Bones, SAS (Lyon, France) merged to form In2Bones Global, Inc., a Delaware corporation headquartered in Memphis. Since the merger, and in addition to these two new Systems, the company has launched several innovative products including the NeoView® PEEK Distal Radius Plate, the NeoSpan® SuperElastic Compression Staple, the Reference Toe System™, AlloAid® PIP, AlloAid® Nail and the CoLink™ Forefoot Plating System.

“At In2Bones, our goal is to advance the science of extremity surgery,” says Alan Taylor, President and CEO of In2Bones Global. “Our development pipeline is robust and will provide growth opportunities for us around the world.”

For more information about In2Bones Global, Inc. extremity products in the U.S., please contact 844.602.6637, or visit www.i2b-USA.com. In France, visit www.In2Bones.com.

Contacts

Element-R Partners
Susan Duensing, CBC
847.639.8300
susan@rurelevant.com

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Lane Hale Named President & CEO of ECA Medical Instruments

Posted On August 9, 2017 By OrthoSpineNews In Extremities, Spine, Top Stories /  

Thousand Oaks, CA – ECA Medical Instruments, the leading designer and manufacturer of single-procedure torque-limiting and fixed-driver surgical instruments and procedural kits for the medical industry and surgeons worldwide, has named Mr. Lane Hale as President & Chief Executive Officer. The Board of Directors tapped Mr. Hale to build upon the 38-year foundation ECA enjoys in the medical device industry and accelerate growth and market adoption of the company’s novel and proprietary disposable instruments and procedural kits for the cardiac rhythm management, neuromodulation, orthopaedic and spine implant market segments.

Mr. Hale joins ECA from Surgical Frontiers, where he was Executive Vice President and helped launch and operate start-up medtech companies to develop advanced surgical technologies focused on improving surgical outcomes. In the medical device industry since 2005, he spent much of his career partnering with many of today’s leading medical device companies developing new technologies, launching new products, and sustaining manufacturing. Mr. Hale has held leadership roles in business development, operations, and finance at Surgical Frontiers, Insightra Medical, CoorsTek Medical, IMDS and MedicineLodge. Mr. Hale has worked in investment banking for Goldman Sachs and in management consulting focused on process improvement. He received a B.A. and M.B.A. from Brigham Young University.

“Over the past four months, ECA’s Board led an extensive CEO search which included dozens of candidates, and Lane was the Board’s top choice given his experience, background, and personality,” said Rick Rees, Chairman of the Board. “The Board is absolutely confident that Lane is the right leader to guide ECA through its next chapter of transformation and growth. With Lane as CEO, ECA is poised to capitalize on an incredible market opportunity and solidify its first mover advantage and leading market position designing and manufacturing orthopedic and spine disposable instruments and sterile-packed instrument sets. We could not be more excited for Lane, ECA, and our customers.”

“I am very excited to join the ECA team and partner with its customers to provide innovative solutions to the clinical challenges and increasing cost pressures they are facing,” said Mr. Hale. “ECA has been a leader in disposable instruments and sterile-packed procedural kits for many years. We have launched these products, which includes proprietary ECA technology, with market leading orthopedic, cardiovascular, cardiac rhythm management and neuromodulation implant OEMs throughout the world. As more OEM’s, hospitals, and ambulatory surgery centers have begun realizing and pursuing the important benefits of single use instrumentation, including operating room efficiency, cost savings, and patient safety, we are poised to be their preferred strategic partner.”

Mr. Hale will be based at ECA’s headquarters in Thousand Oaks, CA, which includes its design center of excellence and turnkey precision-machining, injection molding and clean room operations. ECA operates out of two buildings consisting of over 40,000 square feet of sales and marketing, manufacturing, engineering, quality assurance and administrative space.

ECA’s disposable instruments and procedural kits are gaining increased popularity and demand by
medical device implant OEMs given their ability to eliminate instrument life cycle costs by over $1,000 per procedure, reduce the risk of surgical site infection, provide perfect implant fixation with calibrated torque-limiters, and improve operating room efficiency. They are used widely by the world’s top medical device firms for securing trauma, extremity, and spine implants and are the industry standard for installing every pacemaker, defibrillator and neurostimulation device.

About ECA Medical Instruments
ECA Medical Instruments®, a LongueVue Capital Partners company, was founded in 1979 and located in Thousand Oaks, CA. ECA is the industry leader in single-procedure torque-limiting instruments and surgical fixation kits. The company has manufactured and delivered over 32 million precision torque instruments to the world’s leading producers of CRM, neuromodulation, cardiovascular and orthopaedic and spine implants resulting in over 500 million precision surgical actuations. Every 20 seconds of every day an ECA torque instrument or procedural kit is used to secure a medical implant—one patient at a time. ECA is an ISO 13485, CE Mark certified and FDA registered company and was named Business of the Year 2012 by the Pacific Coast Business Times. www.ecamedical.com

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Knee surgery: Have we been doing it wrong?

Posted On August 7, 2017 By OrthoSpineNews In Extremities, Sports Medicine /  

August 7, 2017, MDLinx/University at Buffalo Health and Medicine News

Cleaning up loose cartilage is not always beneficial, according to a new University at Buffalo study that could impact athletes and seniors, reduce health care costs.
A team of University at Buffalo medical doctors has published a study that challenges a surgical practice used for decades during arthroscopic knee surgery.

When treating meniscal tears surgeons also have clipped and smoothed any dislodged cartilage they found in the belief it was helping patients. But the new study finds that practice does not benefit the patient. Patients who did not have dislodged cartilage removed, recovered faster, with less pain, and ended up a year later with identical results.

“Those with less surgery got better faster in comparison with the people we did more surgery on,” said Leslie J. Bisson, MD, professor and chair in the Department of Orthopaedics at the Jacobs School of Medicine and Biomedical Sciences at UB and lead author of the study.

The finding was so surprising that an editor at The Journal of Bone & Joint Surgery, which published the study, also published a commentary that said, “The conclusion that unstable cartilage lesions do not need debridement could have a dramatic impact on practice management, save health–care dollars, and improve early patient outcomes.”

The American Academy of Orthopaedic Surgeons also distributed the study on its weekly collection of papers of note.

 

READ THE REST HERE

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Orthofix to Present at Canaccord Genuity Annual Growth Conference

Posted On August 4, 2017 By OrthoSpineNews In Extremities, Spine /  

August 04, 2017

LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix International N.V. (NASDAQ:OFIX), a diversified, global medical device company, today announced that President and Chief Executive Officer Brad Mason will present at the Canaccord Genuity 37th Annual Growth Conference in Boston, MA on Thursday, August 10, 2017 at 1:30 p.m. ET.

A live audio webcast will be available on the Company’s website at www.orthofix.com by clicking on the Investors tab and then clicking the link on the Events and Presentations page.

About Orthofix:

Orthofix International N.V. is a diversified, global medical device company focused on improving patients’ lives by providing superior reconstructive and regenerative orthopedic and spine solutions to physicians worldwide. Headquartered in Lewisville, Texas, the Company has four strategic business units: BioStim, Biologics, Extremity Fixation and Spine Fixation. Orthofix products are widely distributed via the Company’s sales representatives and distributors. In addition, Orthofix is collaborating on research and development activities with leading clinical organizations such as Brown University, Sinai Hospital of Baltimore, Cleveland Clinic, Texas Scottish Rite Hospital for Children, and the Musculoskeletal Transplant Foundation. For more information, please visit www.orthofix.com.

Contacts

Orthofix International N.V.
Investor Contact:
Mark Quick, 214-937-2924
markquick@orthofix.com
or
Media Contact:
Denise Landry, 214-937-2529
deniselandry@orthofix.com

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MiMedx Initiates Phase 3 Plantar Fasciitis Clinical Trial

Posted On August 3, 2017 By OrthoSpineNews In Extremities /  

MARIETTA, Ga., Aug. 2, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare, announced today that the Company has initiated its Phase 3 Plantar Fasciitis clinical study.

The Company submitted a formal Investigational New Drug (IND) amendment to the Food and Drug Administration (FDA) requesting the initiation of the Phase 3 trial based on the interim results of its IND Phase 2B trial for the treatment of Plantar Fasciitis. To date, the Company has received no comments or changes to the amendment filing or the Phase 3 protocol, and the Company is moving forward with the Phase 3 trial. MiMedx anticipates enrolling the first Phase 3 patient within the next 30 to 60 days.

The Phase 3 clinical study is a prospective, double-blinded, randomized controlled trial of AmnioFix Injectable as compared to a saline placebo injection in the treatment of Plantar Fasciitis on subjects that have moderate or severe pain due to Plantar Fasciitis with failed treatment for at least one month. The comparison group will be treated with a 0.9% Sodium Chloride USP placebo injection. Approximately 164 patients will be enrolled in the study with an estimated enrollment period of 18 months. The primary efficacy endpoint will be the change in Visual Analog Scale (VAS) score for patients between baseline and Day 90 expressed as the difference in means between the AmnioFix Injectable versus placebo-treated group. The primary safety endpoint will be the incidence of Adverse Events, Serious Adverse Events, and Unanticipated Adverse Events during the first 180 days post injection in the AmnioFix Injectable group versus the placebo-treated group.

MiMedx also reported that the Company will be hosting a webcast on Monday, August 7, 2017 beginning at 2:00 p.m. Eastern Time to discuss this study as well as the progress of the Company’s numerous other clinical studies in support of its Biopharmaceutical strategy. MiMedx executives “Pete” Petit, Chairman and CEO; Bill Taylor, President and COO; Debbie Dean, Executive Vice President; Chris Cashman, EVP and Chief Commercialization Officer; and Mark Landy, Vice President Strategic Initiatives, will be presenting during the August 7th call. Also present will be Donald Fetterolf, M.D., Chief Medical Officer; Thomas Koob, PhD, Chief Scientific Officer; and other members of MiMedx senior management.

The Company expects the planned presentations to last approximately 45 minutes. After the planned presentations, the call will be open for questions and answers. The subject matter, topics and updates to be covered during the formal presentations include:

  • Update of Biopharma Transition Activities
  • Initiation Status of Plantar Fasciitis IND Phase 3 Study
  • Update on Plantar Fasciitis IND Phase 2B Study
  • Upcoming Filings for Additional IND Clinical Studies
  • Plantar Fasciitis and Pain Management Commercial Update

A listen-only simulcast of the MiMedx August 7, 2017 shareholder call will be available on-line at the Company’s website at www.mimedx.com beginning at 2:00 p.m. eastern time, August 7, 2017. A 30-day on-line replay will be available approximately one hour following the conclusion of the live broadcast on the Company’s website at www.mimedx.com.

About MiMedx
MiMedx® is a biopharmaceutical company developing and marketing regenerative biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind our mission to give physicians products and tissues to help the body heal itself.  We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization.  MiMedx is the leading supplier of placental tissue, having supplied over 900,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Important Cautionary Statement
This press release includes forward-looking statements, including statements regarding the timing, results, and publication of clinical studies; and the potential safety and efficacy, and additional approved uses and markets for our products. These statements also may be identified by words such as “believe,” “except,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that unexpected concerns may arise from additional data or analysis from our clinical trials; regulatory submissions may take longer or be more difficult to complete than expected; and that regulatory authorities may require additional information or further studies or may fail to approve or may delay approval or grant marketing approval that is different than anticipated. For more detailed information on the risks and uncertainties associated with new product development and commercialization activities, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

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http://www.mimedx.com

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Orchid Design Hires New Director of Engineering

Posted On July 28, 2017 By OrthoSpineNews In Extremities, Spine /  
Shelton, CT, July 28, 2017 –(PR.com)– Orchid Design (Orchid), a leader in innovative surgical device design, development and regulatory services for the orthopedic and spine industry, is pleased to announce the appointment of a new Director of Engineering for its Shelton, Connecticut design center. Poised for continued growth, Orchid has added Brandon Beckendorf to oversee the development of orthopedic and spine products for Orchid’s customers.
Brandon comes to Orchid with strong product development experience in extremities, craniomaxillofacial, and sports medicine. Most recently, as the Director of Engineering at OsteoMed, he introduced lean product development, DFx, concurrent engineering, and a disciplined approach to project management to increase overall project performance. In his roles at both OsteoMed and Arthrex, Brandon developed a strong understanding of FDA regulations and product development know-how required for the global development of orthopedic implants and instruments. Brandon earned a ME and BS in Biomedical Engineering from Texas A&M University.
“We are pleased to have Brandon join our team to continue to build on our 14 years of helping our customers launch innovative new products to help surgeon and their patients. His demonstrated leadership and product development expertise will expand our capabilities to drive new products to market for our customers,” Steve Maguire, General Manager, Orchid Design.
About Orchid Design
Orchid Design, a division of Orchid Orthopedic Solutions, is the orthopedics industry leader in innovative surgical device design, development and regulatory submission services. Utilizing their ISO 13485 certified product development process, Orchid Design partners with device companies to help bring their ideas to life and streamline the pathway to commercial launch. The company has two design centers located in Shelton, CT and Memphis, TN, focused on the orthopedic medical device market. For more information about Orchid, visit the company’s website at www.orchid-ortho.com/about-orchid-design.
About Orchid
Orchid is a worldwide leader in design and manufacturing for the orthopedic and medical device markets. Orchid is able to do this by compressing time to market, providing new technologies and being the best total supply-chain value. Orchid provides expertise in design and development, quality and regulatory support, implant manufacture, advanced machining, plastics technology, instrument manufacturing, implant coatings, surface treatments, and packaging services. With 14 world-class facilities located around the globe, Orchid continues to provide others an opportunity to live a better life through the products, services and the way the company conducts business. For more information about Orchid, visit the company’s website at www.orchid-ortho.com.
Contact Information
Orchid
Abbie Woolston
517-694-2300
Contact
www.orchid-ortho.com
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Paragon 28® announces launch of JAWS™ Nitinol Staple System to address fracture and osteotomy fixation of the foot

Posted On July 26, 2017 By OrthoSpineNews In Extremities /  

ENGLEWOOD, Colo., July 24, 2017 /PRNewswire/ — Since its inception, Paragon 28 has obsessed over every aspect of foot and ankle surgery. Committed to creating tailored solutions to improve surgical outcomes, Paragon 28 has launched innovative products and instrumentation to help streamline medical procedures, allow surgeons flexibility in technique and approach, and facilitate reproducible results benefiting both the surgeon and patient.

Paragon 28 designed the JAWSTM Nitinol Staple System for use in an osteotomy, arthrodesis and fragment fixation of bones and joints of the foot including fixation of small bone fragments.

The JAWSTM Nitinol Staple System uses superelastic nitinol and a simple insertion method to gain rigid compression across an osteotomy site. Unlike many competitive implants, the JAWSTM Nitinol Staple System has a lightweight titanium inserter that allows the surgeon to fully seat the staple before it is released from the inserter. This allows for final placement of the staple before the staple compresses the osteotomy site.

Achieve compression upon insertion; no heating or electrical activation is required.

A low profile bridge (1.2 mm vs. competitive 1.5 mm or greater) helps minimize soft tissue irritation while the sharp-tooth geometry increases pull out resistance and helps resist migration during healing. Paragon 28 optimized the shape, angulation, and size of the staple legs to distribute compression evenly along the length of the legs. This helps eliminate plantar gapping and ensures consistent force across the osteotomy site.

All instrumentation for the JAWSTM Nitinol Staple System comes in a self-contained, disposable, sterile kit. The JAWS Nitinol Staple comes pre-loaded on the inserter to help facilitate a quick and straightforward surgery.

About Paragon 28, Inc. 
Paragon 28, Inc. was established in 2010 to address the unmet and under-served needs of the foot and ankle community. We believe that through research and innovation we can create new and improved solutions to the challenges faced by foot and ankle specialists.

Product Pages: http://www.paragon28.com/products

CONTACT: Jim Edson, jedson@paragon28.com

 

SOURCE Paragon 28, Inc.

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http://www.paragon28.com

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Paragon 28® expands innovative product portfolio with the launch of the PROMO™ Triplanar Hallux Valgus Correction System

Posted On July 21, 2017 By OrthoSpineNews In Extremities /  

ENGLEWOOD, Colo., July 21, 2017 /PRNewswire/ — Since its inception, Paragon 28 has obsessed over every aspect of foot and ankle surgery. Committed to creating tailored solutions to improve surgical outcomes, Paragon 28® has launched innovative products and instrumentation that help to streamline procedures, allow surgeons flexibility in technique and approach, and facilitate reproducible results benefitting both the surgeon and patient.

PROMO or Proximal Rotational Metatarsal Osteotomy is a hallux valgus correction system designed to allow complete bunion correction in multiple planes. Recent studies have shown that up to 87% of hallux valgus (bunion) deformities contain a frontal plane rotational deformity.1  While traditional single-plane procedures such as the scarf or chevron osteotomes only correct the transverse deformity, PROMO simultaneously corrects the metatarsal internal pronation as well as the varus deformity through a single, oblique osteotomy.

The patent-pending PROMO System contains a series of custom jigs and implants utilized in the measurement, construction and fixation of an oblique plane osteotomy specific to the patient’s deformity. Unique plates are included that are sized and shaped around the oblique angulation of the osteotomy. PROMO also includes a PRECISION™ guided system which enables the user to place a cross screw across the osteotomy while avoiding hardware collision with the plating construct.

Features & Benefits:

  • Corrects all deformity parameters including rotation in the frontal plane
    • May help decrease chance of recurrence2
  • Single Oblique Osteotomy
    • Reduces the likelihood of shortening which can help prevent transfer metatarsalgia
    • Osteotomy allows for placement of an interfragmentary screw which increases the rigidity of the construct
  • Custom jigs aid in construction of the oblique plane osteotomy
    • Repeatable and streamlined technique
  • Avoids fusing the first TMT joint
    • Helps sustain patient joint health

Paragon 28 is grateful for the significant contributions Dr. Emilio Wagner, MD, and Dr. Pablo Wagner, MD, made as surgeon designers of this system.

For additional information on the PROMO™ Triplanar Correction System, visit the Paragon 28 website at www.Paragon28.com.

1  Kim Y, Kim JS, Young KW, et al. A new measure of tibial sesamoid position in hallux valgus
in relation to the coronal rotation of the first metatarsal in CT scans. Foot Ankle Int. 2015; 36(8): 944-52.

2  Wagner P, Wagner E, Ortiz C. Rotational osteotomy for hallux valgus.
A new technique for primary and revision cases. Tech Foot Ankle Surg. 2017; 16(1): 3-10

Contact: Jim Edson, Director of Product Management and Marketing, jedson@paragon28.com

 

SOURCE Paragon 28

Related Links

http://www.Paragon28.com

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