Davide Bianchi, Global President It was yet another monotonous day for David but things were about to change. After a long, busy, and exhausting day at work, skittering across destinations as a pizza delivery boy, David was all set to unwind on the way back home. Along the way, David—who had trained for years as a competitive BMX cyclist in Hungary—realised that a car was turning in front of him, and in the blink of an eye, it hit him on his right side. “From there, I remember waking up on the sidewalk, and I couldn’t move my right leg. That’s how I knew there was a big problem,” recalls David.
Every bone in David’s right leg was broken, his foot crushed, and the nerves, which provide feeling to the lower leg had been severed. Not one, but two different surgeons recommended amputating the 22-year-old’s right leg. Understandably, David was devastated. David was desperate for another opinion. Orthopaedic Surgeon Dr. Satyagit Naique offered a glimmer of hope. Together with plastic surgeons, Dr Naique performed multiple surgeries, including a free flap procedure, where tissue and an artery from David’s scapula were used to restore the skin and blood flow to his foot. This is where Orthofix Extremities’ TL-HEX™ system, an extremity fixation device that keeps bone segments aligned during the healing process, came into the play—making the impossible possible. The successful procedure saved David from the amputation of his leg and breathed new life into his passion for cycling. Needless to say, David was alive again. “It was fantastic to sit on a bike again and jump through the air,” says David. ”One of my dreams came true again. It is an unbelievably great feeling.”
Stories akin to that of David’s are indicative of Orthofix Extremities’ determination to upset the apple cart, make waves and rock the boat in the orthopaedic sector with sheer innovation. With a culture conducive to innovation, Orthofix Extremities is shaping the way orthopaedic surgeons and physicians can restore the quality of life for patients in need of reconstructive and regenerative orthopaedic and spine solutions. “Orthofix Extremities is all about innovation. Our talented and passionate team of people focused on improving and, in some cases, saving patient’s lives, is born from innovation, evolved through innovation and still committed to innovation,” says Davide Bianchi, Global President, Orthofix Extremities—a strategic business unit of Orthofix Medical.
A global medical device company, Orthofix Medical is focused on musculoskeletal healing products and value-added services. With a singular focus on improving patients’ lives, the company specialises in providing superior reconstruction and regenerative musculoskeletal solutions to physicians worldwide. Besides Orthofix Extremities, Orthofix Medical also has another business unit, Orthofix Spine, which includes bone growth stimulation products, biologics, spine fixation implants and motion preservation devices. The two strategic business units distribute cutting-edge products in more than 70 countries worldwide. Through the convergence of employees, patients, and passion, Orthofix Extremities is relentlessly enhancing the dynamics of the orthopaedic market, making a difference in the lives of patients through innovative medical devices and biologic solutions. “We are the leader in external fixation, where minimally invasive devices are applied externally to the bone to support fracture healing and deformity correction. We are also focused on developing software, mobile apps, and support materials for postoperative treatment,” informs Bianchi. In order to address multiple challenges in this realm, the company focuses on developing solutions for Charcot Foot treatment, paediatric and limb reconstruction, trauma, and medical education verticals.
Making a Difference
Before diving into the features and functionalities of the diverse range of solutions, Bianchi stresses the global prevalence of diabetes—the seventh leading cause of death in the U.S. “Up to 80 percent of the diabetic patients are more likely to die within five years of having a limb amputation; 0.3 to 7.5 percent of diabetic patients may develop a Charcot Neuroarthropathy, whereby a minor injury can lead to amputation. While 85 percent of leg amputations are a result of a diabetic foot ulcer, 4 out of 5 limb amputations can be prevented,” states Bianchi, who brings over 25 years of global experience in medical devices, leading his team at Orthofix Extremities to achieve their goals and vision.
While ‘Saving a Limb, Saving a Life’ has become the focal point of treating patients with risk of diabetes-related amputations, the Orthofix Extremities team is determined to leverage its experience in providing solutions for challenging conditions in other areas of orthopaedics and bring devices and services to physicians worldwide to tackle this life-threatening condition. “Starting from our product portfolio through our services to our high-quality educational programs, we believe we can help surgeons offer patients the opportunity to return to an active, near normal life,” adds Bianchi. For treating a wide variety of deformities, joint fusions, fractures, and complex corrective osteotomies, Orthofix Extremities has devised the TrueLok™ Ring Fixation System—an external fixation system used as a static offloading option for patients with Charcot foot deformity with or without associated ulcers.
The TrueLok frames are user-friendly, featuring pre-built components, enabling surgeons to build the optimal frame to meet their patients’ needs. The excellent stability of the frames makes it an ideal choice for correcting and offloading Charcot foot reconstructions.
Starting from our product portfolio through our services to our high-quality educational programs, we believe we can help surgeons offer patients the opportunity to return to an active, normal life
Orthofix Extremities Foot and Ankle product portfolio also includes the G-Beam™ Fusion Beaming System—a dedicated product line, designed with Charcot specific indications in mind. The G-Beam Fusion Beaming System meets the extreme demands of Charcot foot reconstruction with its unique combination of the manufacturing material and the implant dimensions. The stability and stiffness of the G-Beam device makes implantation easy with user-friendly instruments designed to help surgeons treat their patients with confidence. The portfolio also includes a TTC (tibial-talar-calcaneal) fusion nail—the AHN™ (Ankle Hindfoot Nail)—that ensures adequate pressure on the joints to facilitate arthrodesis (fusion).
Let Patients Achieve their Potential
Paediatrics and limb reconstruction forms an integral dimension of the company’s reconstruction and regenerative musculoskeletal solutions. Born as a paediatric company, Orthofix Extremities’ monolateral devices were developed to perform the first surgeries to address paediatric pathologies such as achondroplasia. With a long history of developing innovative and leading-edge solutions, Orthofix has now brought all of its paediatric expertise and products together under the JuniOrtho™ banner, which is a range of products and resources dedicated to children and young adults with bone fractures and deformities.“We are committed to thinking, planning, and engineering products and services for kids and young adults. Adapting standard adult products to children is simply suboptimal and Orthofix is changing that. We immerse ourselves in the process and offer help and support before, during, and after surgery,” asserts Bianchi.
Besides a long history of products that have completely changed the surgical approach in the area of paediatric and limb correction, Orthofix Extremities’ latest software supports the patient recovery even further with systems and applications, guiding the patient in every step of their journey toward their final healing. Bianchi adds, “The paediatric and limb reconstruction area is a part of our DNA. Working in this niche, we help children who have never walked before to finally have an almost normal life.” In order to accomplish this goal, Orthofix Extremities brings in TL-HEX TrueLok Hexapod System™, used to treat fractures as well as debilitating pathologies and to help the patients to go back to their normal activities. The latest software addition is the myHEXplan™ mobile app to support the patient in the postoperative phase.
Orthofix Extremities’ eight-Plate™ Guided Growth™ System has taken a revolutionary approach to help paediatric patients correct bone deformities through a minimally invasive procedure. The implant acts as a flexible hinge, permitting growth at the growth plate to gradually straighten the limb. The product line for paediatrics and limb reconstruction also features the Galaxy Fixation™ Pediatric Kit–the only sterile kit specifically developed for the paediatric market and ideal in emergency cases.
Standardising Techniques Where the Unexpected is Expectable
Innovation at Orthofix Extremities doesn’t stop there. While the world we reside in has become a tragic theatre of many conflicts that affect thousands of civil victims, Orthofix Extremities is committed to providing adequate stability and allowing for early functional recovery in case of trauma, particularly in mass casualties—natural disasters, humanitarian crises and terror attacks. Keeping in line with the company’s philosophy of changing lives by providing innovative solutions to complex and challenging conditions, the Orthofix Trauma product line comprises medical devices designed to ‘save a life, save a limb and function’, as well as manage secondary post-traumatic reconstructive procedures. The company offers one of the most comprehensive and modular external fixation system—the Galaxy Fixation system—that is indicated for fracture fixation as well as fracture treatment—be it an emergency in the field hospital with limited resources or a Level I trauma centre. Orthofix’s simple, effective, ready to use, sterile, dedicated implant kits designed for a wide range of anatomical sites have proven vital in managing damage control orthopaedics in the face of emergencies of unexpected proportions.
Orthofix also offers the Chimaera™ Hip Fracture System, which is designed to facilitate swift and adequate fixation to treat hip fractures and the Galaxy Fixation Shoulder system that can be leveraged for the most common proximal humeral fractures with a minimally invasive approach.
In addition, for managing long bone fractures, Orthofix’s XCaliber™ monolateral external fixators are available in three ready-to-use, sterile configurations, designed to manage most common long bone fractures. The built-in features of XCaliber monolateral external fixators allow versatility in fracture reduction, fixation, and management depending on the type of fracture. Through a minimally invasive surgical approach the company’s Calcaneal Minifixator™ helps to accomplish three goals without compromising the soft tissue envelope: restores the height of the heel, decreases the width of the heel to decompress the peroneal tendons, and reduces the articular surfaces and it can be used on either the left or right foot.
All the products in the Orthofix Trauma portfolio are made available in dedicated sterile kits to avoid maintenance and sterilisation costs. Following the increase of mass shootings, terrorist attacks and natural disasters (like the multi-site attack in 2015 in Paris, at the Bataclan Theatre, the stadium and some restaurants), Orthofix—along with its complete range of sterile kits conceived for emergency situations—has created a comprehensive training program on mass casualty management open to surgeons, nurses and administrative staff. The main objective is to improve mass casualty incident management with appropriate preparedness plans.
Innovate and Educate
As Orthofix Extremities keeps abreast of the latest in technologies, the company also acknowledges the pivotal role played by medical education in informing surgeons about the latest medical knowledge. Medical education has always been the flagship of the company’s efforts. As a part of the Orthofix DNA, bona fide medical research, education, and enhancement of professional skills are imparted to improve patient safety and increase access to new technology.
"Orthofix Extremities is all about innovation. Our talented and passionate team of people focused on improving and, in some cases, saving patient’s lives, is born from innovation, evolved through innovation and still committed to innovation"
Besides facilitating the safe and effective use of Orthofix products, the Orthofix Academy™— is focused on the latest educational, clinical, and scientific needs of orthopaedic healthcare professionals worldwide. “Through an extensive range of learning and discussion opportunities, consisting of both in-person and remote training activities, practical sessions in wet and dry labs, peer-to-peer debates, interactive clinical discussions, publications, and research projects, we are fully committed to advancing professional orthopaedic skills and to progress education,” says Bianchi.
Every year Orthofix trains more than 2,000 orthopaedic professionals in more than 70 countries worldwide with a wide range of medical education activities. The company’s cutting-edge Education Center called the Orthofix Academy in Verona, Italy is the education hub. This site provides the opportunity for course participants to be immersed in Orthofix’s positive atmosphere and have contact with the largest number of Orthofix team members possible while attending an orthopaedic training. Courses are also held in The Orthofix Institute in Lewisville, Texas, U.S. as well as in other locations around the globe.
The Orthofix learning curriculum, consisting of three levels of courses for developing tailored medical training in foot and ankle, paediatrics, limb reconstruction, and trauma, has positively impacted clinical outcomes and the quality of the service in hospitals and private institutes. “Orthofix efforts in medical education worldwide are driven by the needs of our partners in the perspective of a long-lasting partnership to improve clinical practice, simplify hospital organisation and minimise costs related to orthopaedic procedure management,” adds Bianchi.
An Unwavering Determination
Orthofix’s genesis traces back to the 70s in Italy, when the orthopaedic researcher Giovanni De Bastiani, proposed the concept of “dynamization” and developed a modular external device, designed to create the most favourable physiological conditions at each stage of fracture healing. Since its foundation in 1980, Orthofix has designed its range of external fixators to allow the release of axial forces in the external frame at an appropriate point in the healing cycle, thus transferring a progressive load to the fracture site.
With a passionate team comprised of more than 1,000 employees (280 of which employed in the Extremities business unit), Orthofix manifests an unwavering determination to improve patients’ lives, driven by a culture of integrity. Orthofix has collaborated with leading clinical organisations such as MTF Biologics and the Texas Scottish Rite Hospital for Children, along with leading physicians and healthcare organisations, to continue its efforts to develop innovative products. High quality clinical data is generated through collaboration with experienced surgeons, applying the philosophy of Good Clinical Practice. Orthofix works closely with European Notified Bodies to ensure the standards and indications provided previously by the MDD and now by the new European MDR (Medical Device Regulations), which will apply starting May 2020, as well as the applicable FDA and federal healthcare program requirements.The team is looking forward to unlocking new opportunities. “For the future, sensorised, wearable medical devices or the ability of current orthopaedic devices to carry sensors with diagnostic capabilities will be the way forward, especially with data analytical features,” concludes Bianchi.
Description Orthofix Medical Inc. is a global medical device company focused on musculoskeletal healing products and value-added services. The company’s two strategic business units, Orthofix Spine and Orthofix Extremities, distribute cutting-edge products in more than 70 countries worldwide
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