These relationships are the key to success in medical device sales. Mutually-beneficial relationships are built on common interests and goals, trust and consistent, valuable communications. Each relationship is unique in its circumstances, product needs, purchasing expectations and current alliances. The process of identifying and establishing these valuable relationships in medical device sales isn’t always straightforward, and can be a minefield of trial and error.

Knowing before you go to your first or subsequent meetings, can give a sales representative an edge on the competition by identifying the healthcare institutions and surgeons that are interested in a specific product and operate in an environment that is receptive to that product due to the healthcare institution’s current contracting status and purchasing objectives. Having a resource to assist in navigating these complex and, sometimes obscured, relationships like contract positioning, group purchasing organization affiliations, surgeon-hospital relationships, surgeon-manufacture relationships, surgeon training history and current procedure profile will be a driver of medical device sales success today and well into the future.

Schedule a live demo to learn more about MedTechIntel, a relational, intelligent software program that assists in navigating the complex medical devices selling environment.

Historically, surgeons had to choose between either a system that enables compression to the bone or a system that is designed to prevent screw back-out, but both of these are required for optimal results. Contouring to the bone allows a small amount of motion (micro-motion), which facilitates bone healing. Securing the screw fixation to the plate helps prevent catastrophic failure due to screw back-out.

The Leith system addresses critical surgical priorities in a truly remarkable hybrid system: allowing micromotion to stimulate physiologic bone healing, but at the same time, prohibiting any screw backout and fixation failure. The simple design does not require towers or cones to guide insertion of screws, which streamlines the surgical process and increases reproducibility of results. In addition, the screws can be inserted 25 degrees off axis and 50 degrees circumferentially setting it apart from the current market standard that only allow 15-18 degree angles. This extra angulation allows surgeons to better capture bone fragments, creating a more efficient process whereby complicated fracture reductions and fusions can be fixated solidly and with confidence, in their entirety, using a plate construct. Dr. Arush Angirasa, who specializes in Foot and Ankle trauma and reconstructive surgery at Southwest Orthopedic Group, commented, “This is a huge leap forward in technology to allow fractures to be fixed in a more effective way.”

Leith is launching with four plate systems, each with a low profile design, allowing the screws to sit flush with the bone without prominence regardless of angulation, thereby eliminating soft tissue envelope impingement concerns. The 1st tarsal-metatarsal (Lapidus), lesser tarsal-metatarsal, and 1st metatarsal phalangeal joint systems will be used in the forefoot and midfoot to address acute fractures and reconstructive surgeries while the lateral malleolar fracture plates can be utilized for fixation of a variety of distal fibular fracture patterns. The 510(k) clearance also authorizes Leith to launch several other systems including additional tibial and fibular plating systems, providing a comprehensive ankle portfolio for fracture repair and fusions.

“Receiving FDA clearance is very exciting, and our first surgery is schedule for Tuesday, March 2,” stated CEO Tim Leak. “This is the first of many products we are developing with our One screw, One step technology, but for now our primary focus is getting the foot and ankle system into the operating room.” See First Surgery here

About Leith Medical
Leith Medical is dedicated to changing the way orthopedic surgeries are performed with simple, common sense solutions. They are located in Austin, TX. Connect with Leith Medical at www.leithmedical.com or on LinkedIn and Facebook.

Contact: Candace Leak, Leith Medical

Email: info@leithmedical.com

The patient, a 37-year-old former semi-professional baseball player who has had back and leg pain for more than ten years, has been unable to work several times per year due to pain. The pain had worsened, and the patient began having difficulty arising from a seated or prone position. He has had multiple treatments, including oral medications, injections, physical therapy, chiropractic care and acupuncture, which allowed him short periods of relief.

Surgery was done through a midline lumbar approach, with minimal disruption of the soft-tissue to preserve the musculature and decrease recovery time and pain. The pressure on the patient’s nerves was relieved by removing the lumbar disc and osteophytes (bone spurs), which allowed a return of the nerve function in the legs and stopped the nerve irritation. With the removal of the lumbar discs, spacers (or cages) were used to restore the disc height and further take pressure off of the nerves. Pedicle screws were then placed, providing the stability needed to allow the patient to start walking the same day. Bone grafting from the patient’s own bone was used to improve the patient’s fusion healing and bone union.

“Patients who need spine surgery want a less painful recovery which allows them to become functional more quickly,” explains Dr. Jeffrey R. Carlson, orthopaedic surgeon and President and Managing Partner of Orthopaedic and Spine Center. “Spine surgery techniques and pain management have so improved over the past ten years that I routinely perform outpatient lumbar fusions in single and two levels. Now, we have seen that same evolution with three-level lumbar fusion surgical techniques. Patients experience much less pain and can be home the same day.”

“The patient was up walking and discharged to go home within an hour of surgery —  he was doing very well in our follow-up call later that evening,” said Dr. Boyd W. Haynes III, President of Coastal Virginia Surgery Center. “Our patients have active lifestyles and when they need surgery, they prefer to recuperate at home with supportive care. Advanced surgical techniques and improved pain management have made even complex surgeries like this one an outpatient reality. We built Coastal Virginia Surgery Center to address our patients’ surgical needs today and in the future. We wish him all the best as he recovers!”

OSC physicians are accepting new patients, and CVSC is still scheduling surgeries, both with additional precautions during the COVID-19 Pandemic. To make an in-person, telehealth, or phone appointment with an OSC provider, call (757) 596-1900 or visit www.osc-ortho.com.

About Jeffrey R. Carlson, M.D.

Dr. Jeffrey Carlson has been a part of Orthopaedic & Spine Center since 1999 and serves as the President and Managing Partner. He is a board-certified, fellowship-trained orthopaedic surgeon who focuses on the treatment of injuries and disorders of the spine.

About Orthopaedic & Spine Center

Orthopaedic & Spine Center (OSC) is staffed by outstanding medical professionals who strive to provide the very best orthopaedic and interventional pain management care available anywhere. Our Center includes a comfortable, state-of-the-art medical facility, pleasant and well-trained personnel, physicians trained in the most advanced orthopaedic treatments, interventional pain management procedures, regenerative medicine, using stem cell and platelet therapies and a dedication to patient care.

About Coastal Virginia Surgery Center

Coastal Virginia Surgery Center (CVSC) is a fully certified ambulatory surgery center through the Accreditation Association for Ambulatory Health Care, Inc. (AAAH) staffed by outstanding medical professionals who strive to provide the very best care available. The Center includes four surgical suites with state-of-the-art technology and pleasant personnel trained in the most advanced orthopaedic treatments, interventional pain management procedures, regenerative medicine and old-fashioned patient care.

Anisotropic lattice properties enable a method of reducing stress shielding of new bone growth in spinal fusion procedures.  Similar to cancellous bone’s natural structure, this technology allows a lattice to exhibit mechanical properties varying with direction of force.  For instance, bone in the spine is often stiffer in the rostral-caudal direction as compared with anterior-posterior.  Matching elastic modulus in the direction defined by the loading of the spine is desirable because it allows the endplates of the adjacent vertebrae to move relative to one another, enabling loading of the new bone.   HD’s durable and reliable lattice structure allows the sufficient strength of the interbody to provide stability during daily life, while allowing load sharing with newly forming bone.

“This technology allows implants to further match physiological conditions as they vary with loading direction.  Combined with the lattice’s internal volume curated to match the physiological dimensionality of bone substrates, this provides a strong tool for bone formation”, added Ian Helmar, Co-Founder and Vice President of Research & Development at HD LifeSciences, LLC.

————————————————

About HD LifeSciences

HD LifeSciences is a pioneer and leading innovator in 3D printed spinal interbody fusion implants and instrumentation. The company’s proprietary, biomimetic Soft Titanium technology clearly distinguishes their products in the $1.5B spinal interbody fusion device market. The Hive portfolio of interbody fusion devices provide surgeons and their patients ideal biomechanical elastic modulus properties, clear and precise diagnostic imaging capability, osteoblast cell attraction and integration – all features that lead to consistently strong fusion constructs and efficacious clinical experiences.

HD Lifesciences is located in Woburn, Massachusetts U.S.A

Contact: Patrick O’Donnell at patrick.odonnell@hdlifesciences.com

Website: www.hdlifesciences.com

CARLSBAD, Calif.–(BUSINESS WIRE)–Spinal Elements, a spine technology company, today announced the relaunch and first clinical use of the Luna^® XD multi-expandable lumbar interbody fusion device and Orbit^® articulating discectomy system. A minimally-invasive transforaminal lumbar interbody fusion (TLIF) surgery was performed with the devices by Richard G. Fessler, M.D., Ph.D of Rush University Medical Group, Chicago, IL.

“I am very pleased to be using both Orbit and Luna XD in my MIS TLIF procedures again,” stated Dr. Fessler. “Orbit is a best-in-class system that allows me to provide a safe and more thorough discectomy while Luna XD’s multi-expandable profile and footprint provides a large area for bone grafting and controlled restoration of disc height and lordosis, contributing to the consistency and positive clinical outcomes of my TLIF procedures. I look forward to sharing these results in an upcoming peer-reviewed publication.”

The Orbit system consists of articulating and rotating discectomy instrumentation that uses a minimal, posterior incision and/or MIS tubular approach to achieve efficient disruption and removal of disc tissue while preparing the endplates for fusion. The novel articulating rotary design allows the instrumentation’s working end to evacuate the full area of the disc necessary for implantation of the Luna XD circular device.

The Luna XD system allows an ALIF-sized, circular implant to be surgically delivered to the intervertebral space through a posterior, minimally-invasive access point. Once inserted, the Luna XD implant first expands horizontally to cover the disc footprint, creating a stable foundation. Then the implant expands vertically up to 16mm to restore disc height. Furthermore, the device includes up to 12° of lordosis to aid in the restoration of sagittal alignment.

Luna XD and Orbit have been integrated as the newest technologies within Spinal Elements’ MIS Ultra platform of products and procedural solutions. At the time of acquisition, the company announced its goal of a relaunch of the technology by the second quarter of 2021 and through the efficiency of its integration team has been able to deliver the goal on a faster timeline.

Jason Blain, CEO of Spinal Elements, stated, “The acquisition and integration of the Luna XD and Orbit technologies into the Spinal Elements MIS Ultra portfolio allows Spinal Elements to continue to deliver innovative and clinically-differentiated technologies to surgeons like Dr. Fessler and their patients. Both of these technologies further our goal of being a driving force that fundamentally changes the way spine surgeons approach and operate in minimally-invasive spinal procedures. I am proud of the execution success our team showed in quickly returning these technologies to market.”

Spinal Elements acquired the Luna XD and Orbit systems in December 2020 along with the assets of the former Benvenue Medical. The company anticipates a resurgence in the surgical use of both products in posterior lumbar fusion spinal procedures.

About Spinal Elements

Spinal Elements is a Carlsbad, California based medical device company focused on the design, development and commercialization of a comprehensive portfolio of systems, products and technologies for spine surgery procedures. A leading designer, developer, manufacturer and marketer of innovative medical devices used in spinal surgical procedures, Spinal Elements combines leading medical device technologies, biologics and instrumentation to create positive surgical outcomes that exceed surgeon and patient expectations. Spinal Elements has built a reputation delivering innovative and differentiated technologies that enable fundamental shifts in solutions for spine surgery. The company markets a complete portfolio of advanced spinal implant technologies.

For more information, please visit www.spinalelements.com.

The TheraFuze DBF Fiber Bag is a 100% allograft tissue alternative to the resorbable polymer mesh bag products that are currently on the market. The Fiber Bag is made from cortical demineralized bone fibers and processed using TheraCell’s proprietary Bone Textile technology. TheraCell’s patented TheraFuze DBF processes have been developed to produce uniform fiber geometry, size and texture, and to preserve the natural collagen structure of the allograft. TheraCell’s FiberLok technology allows the Fiber Bag products to maintain their form and integrity after rehydration, permitting adequate time for manipulation and implantation.           

This next generation posterolateral solution is designed to be an improved alternative to the traditional boat, offering complete containment of added graft material. The Fiber Bag may be packed with autograft or additional allograft material, and the open end of the bag can be sutured for closure following rehydration. The fully contained fiber bag construct may be placed in the posterolateral gutters, in a bone void or cavity, or may be delivered using minimally invasive techniques.

This is the 4^th new product in TheraCell’s comprehensive assortment of procedure-specific graft solutions to recently be commercialized. “The versatility of our technology platform has allowed us to develop and commercialize a range of procedure-specific fiber graft forms to rapidly expand our portfolio of TheraFuze DBF Fiber products,” said Nelson Scarborough, PhD, TheraCell’s Chief Scientific Officer and co-inventor on the Fiber Bag patent, “and the issuance of this new patent further enhances our strong portfolio of intellectual property and demonstrates our ongoing commitment to innovation and leadership in the orthopedic allograft industry.”                         

About TheraCell, Inc.

TheraCell is focused on the development of advanced technologies for bone and soft tissue repair and the inventor of the next-generation TheraFuze DBF® demineralized bone fiber technology.  It is also in the process of bringing its novel O₂ssify oxygenation technology to market that has been demonstrated to supercharge bone formation. Founded in 2008, the firm is headquartered in Los Angeles, CA and maintains offices and laboratories in Littleton, MA. www.theracellinc.com.  TheraFuze DBF®, TheraFuze DBF® Fiber Bag, TheraFuze DBF® FiberLok, Bone Textile and The Bag That Is A Graft are trademarks of TheraCell, Inc.

DUBLIN, Feb. 16, 2021 /PRNewswire/ — Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced that leading spine surgeons across the U.S. have successfully performed minimally invasive spinal procedures utilizing the newly cleared navigated disc prep, interbodies and Midas Rex high speed drills with the Mazor Robotic Guidance System. These recent surgeries mark the next step in the transformation of spine surgery as a result of the increased precision and minimally invasive technique.

These cases demonstrated the improved disc-prep access and interbody navigation, precise drilling, and predictable planning that surgeons expect from the Mazor Robotic Guidance System.

• Dr. Gregory Poulter of OrthoIndy: Performed his first case on a 50-year-old male, a general manager at a construction company who presented with a pinched nerve in his lower back and severe leg pain. Dr. Poulter was able to conduct an OLIF360^sm Single Position Surgery and discharge the patient the following day.
• Dr. Sharad Rajpal of Boulder Neurosurgical & Spine Associates: Conducted his first surgery at Centura-Avista Adventist Hospital using the integrated technology on an 83-year-old male, retired atmospheric physicist suffering from back and severe progressive leg pain and weakness that prevented him from walking. Dr. Rajpal performed an L2/3 decompression fusion and TLIF (Transforaminal Lumbar Interbody Fusion) on the patient, who has been discharged from the hospital and is home recovering with minimal pain and improved functionally.
• Dr. Eiman Shafa of Twin Cities Spine Center: Completed his first minimally invasive TLIF with bilateral instrumentation using expandable interbody technology on a 36-year-old male, boiler operator/maintenance technician with back and severe left lower extremity pain and progressive weakness. The patient was observed overnight and discharged the morning after his surgery. The morning post-surgery, the patient’s radicular leg pain and motor examination had returned to normal.

“Robotic assistance has fundamentally changed how we as spinal surgeons operate,” said Dr. Poulter. “I believe in the benefits of robotics such that I would strongly recommend it to all of my friends or family if they are in need of a lumbar spine procedure, as I see this as potentially life-changing.”

Despite elective surgery shutdowns due to the COVID-19 pandemic, many spinal procedures have continued, deemed essential due to the severity of the patient’s disability.

“I believe this technology allows surgeons to perform their spinal procedures even better through more concise planning and execution in the operating room,” said Dr. Rajpal. “One additional advantage is the versatility of the system. Surgeons can easily integrate the Mazor Robotic Guidance System into their current workflows – whether it’s using a pre-operative planning CT with intraoperative fluoroscopy or using an O-arm for scanning and planning altogether in the operating room. The newest software update and instrumentation sets have also significantly improved the workflow, providing a more intuitive interface for surgeons during the planning phase, to more streamlined steps when executing the surgical plan.”

“We want to congratulate each of these surgeons – and their patients – on successful procedures and recoveries,” said Linnea Burman, vice president and general manager, Enabling Technologies: Cranial & Spinal Technologies, which is reported as part of the Restorative Therapies Group at Medtronic. “We continuously strive to improve the robotic surgery field, and hearing about these great success stories and how these patients’ lives have been affected gives our team more motivation to achieve the next level of advancement.”

About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

[This Article was published in OrthoSpineNews ]

SCOTTSDALE, Ariz., February 3, 2021 (Newswire.com) – NGMedical, a German medical device manufacturer exclusively focused on creating innovative technologies for spinal application, announces FDA clearance for its purely additively manufactured titanium cervical BEE^® cage.

The BEE^® cage is designed to challenge the limits of additive manufacturing. The purposefully designed honeycomb endplate design reduces the risk of subsidence while allowing fusion. The honeycomb structure allows for bony ingrowth and demonstrates the reduced use of titanium minimizing risks of X-ray artifacts, while offering a very large graft space. This is another significant innovation from the team, who invented the first line of additively manufactured interbody devices.

“This is an important step for NGMedical and allows us to start our active market presence in the USA. We are proud having received the FDA clearance based on the innovative design introduced to the OUS market in 2020. Our team did a great job in cooperation with MRC Global,” says Nino Weiland, Operations Manager of NGMedical.

“The approval of the BEE cage is a remarkable accomplishment as it provides maximum surface area due to the honeycomb structure and laterally accessed lumen. This implant, along with its streamlined and elegant instrumentation, is perfectly suited for the U.S. surgeon as it addresses every key metric including: anatomical design for bony fusion, maximum porosity with improved imaging and increased surface area minimizing subsidence,” according to Josh Sandberg of NGMedical, Inc.

“NGMedical is a hard-working, innovative team that worked diligently to ensure all necessary data was provided to support clearance through FDA for the BEE® AM Cage,” says Christine Scifert of MRC Global.

NGMedical, Inc. is actively seeking qualified representation nationwide. If interested in learning more, please call us at (480) 609-4864.

About NGMedical

We are an owner-managed company specializing in the development of innovative spinal implants. Many years of experience, combined with a high degree of creativity, give us the impetus to significantly advance the development of spine surgery.

The NGMedical team has been developing innovative product systems since 2001. NGMedical derived out of the company Advanced Medical Technologies AG, which was acquired by Medtronic Inc. in 2012. NGMedical exploits this longtime experience combined with a high degree of creativity and know-how for the development of further innovative product concepts. Both, earlier and today, the cooperation with a team of experienced surgeons and scientists is the basis for the market-driven orientation. Many product solutions, today accepted and widely used as standards, derive from our team.