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Exactech Transitions from EBM to Laser 3D Printing Implants for Shoulders

Orthopedic implant device maker Exactech wants to scale up the production of its Equinoxe Stemless Shoulder implant by switching from electron beam metal additive manufacturing to direct metal 3D printing with high precision lasers. In an official statement released on July 21, 2020, the Florida-based company announced plans to transition all US stemless shoulder procedures to its laser-printed devices throughout the rest of the year.

As the latest addition to the company’s extremities product line, the Stemless Shoulder, launched in 2018, is a bone conserving prosthesis designed for anatomic total shoulder arthroplasty. Comprised of a stemless cage, humeral head, and cage glenoid, the device offers intraoperative flexibility which is ideal for conserving the bone, said the company. Furthermore, to enhance the probability of biological fixation, it incorporated a laser 3D printed porous bone cage structure that allows bone-through growth, and without the need for a stem, there is more ease of implantation, reduced operating time, and blood loss. Exactech indicated that the innovative combination of 3D porous material and bone cage technology is what differentiates it from competing products on the market.

The new Equinoxe Stemless Shoulder uses laser-printed AM (Image courtesy of Exactech)

Currently, there is a growing trend towards minimally invasive orthopedic surgeries, like stemless shoulder implant procedures mainly led by experts in Germany and France. However, US surgeons also took notice of the benefits of using stemless implants to perform arthroplasties with less bone removal and fewer complications than more conventional anatomic shoulder prosthesis.

Driven by an upsurge in the aging population, longer life expectancy, and rising prevalence of arthritis, the global shoulder arthroplasty market is expected to reach $2.4 billion by 2023, and that includes increased demand for stemless shoulder implants, as forecasted by Koncept Analytics last year. In the US alone, over 53,000 people have shoulder replacement surgery each year, according to the Agency for Healthcare Research and Quality, and with only a handful of stemless shoulder implants cleared by the US Food and Drug Administration (FDA) since 2015 (including the Equinoxe Stemless Shoulder), there is a wide-open market opportunity for medical device manufacturers to exploit. Expecting to become a leading force in the stemless implant market, Exactech is switching technologies to deliver quick solutions for patients and surgeons.

“We have been incredibly pleased with our original EBM [electron beam melting] Stemless Shoulder implant and the early positive clinical feedback we received from our surgeon customers. The new laser-printed device is built on this solid foundation while also giving us the ability to ramp up production to serve even more patients, which drives us and fulfills our mission,” said Exactech Vice President of Extremities, Chris Roche.

Orthopedic surgeons Curtis Noel, of the Crystal Clinic in Akron, Ohio, and Stephanie Muh, of the Henry Ford Health System in Detroit, Michigan, were the first shoulder specialists to perform the surgeries with the Equinoxe Stemless Shoulder implant earlier this month. As a member of the design team, Noel expressed how proud he was to be one of the first to implant the laser-printed Stemless Shoulder, mainly due to the bone conserving design, along with its compatibility to the Equinoxe Shoulder Platform System.

Laser 3D printed porous structure designed to promote bone-through growth (Image courtesy of Exactech)

Muh described that “one of my favorite features of the Stemless implant is its bone cage structure that is designed to provide initial press-fit fixation while also allowing for bone-through growth. That intentional design element, along with the porous structure being designed to mimic the trabecular nature of cancellous bone, differentiates it from competitors.”

In order to design the Stemless Shoulder implant, Exactech engineering researchers collaborated with orthopedic surgeons that combined their knowledge, expertise, and background to come up with a final design structure that could be additively manufactured with optimized pore size, porosity, and count. The design team included Noel; shoulder and elbow surgery expert’s Felix Henry Savoie, from Tulane University, and Joseph Zuckerman from New York University (NYU)’s Langone Orthopaedic Hospital; Pierre-Henri Flurin, from the Clinique du Sport in Bordeaux-Mérignac, in France; Ryan Simovitch, the Director of the Shoulder Division at the Hospital for Special Surgery (HSS) in West Palm Beach, Florida, and Thomas Wright, Director of Interdisciplinary Center for Musculoskeletal Training at the University of Florida.

Pre-operative X-ray (left) and postoperative X-ray (right) showing the laser-printed Stemless Shoulder and Equinoxe Cage Glenoid. (Image courtesy of Stephanie Muh)

As a developer, and producer of innovative implants, instrumentation, and computer-assisted technologies for joint replacement surgery, Exactech targeted clinical evaluations of the Stemless Shoulder immediately after release and has been aggressively expanding and upgrading its product ever since. Just like other manufacturers of stemless implants, the goal here is to try to reproduce the native shoulder anatomy and minimize humeral bone removal. Recent studies. have outlined the numerous advantages – as well as a few disadvantages – of stemless shoulder implant arthroplasty, and although its use is still emerging outside of Europe, the implant is gaining ground with surgeons and patients and is expected to surpass stemmed implants by 2025.

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UK Heart Patient Undergoes Rare Surgery for 3D Printed Titanium Sternum

A Fleetwood, Lancashire woman in the UK is enjoying better health today, able to perform daily tasks at home, not flinching when she coughs or sneezes—but best of all, she is now able to hug her one-year-old granddaughter. All this progress is due to a 3D printed implant fitted and inserted by surgeon, Dr. Ehab Bishay, at University Hospitals Birmingham NHS Foundation Trust.

The 52-year-old patient, Linda Edwards, had been suffering for years with angina, but even after surgery, she suffered further complications as her breastbone became extremely fragile.

After her chest plate collapsed twice post-surgery, it was obvious another solution was needed—but without anything to attach another metal plate to, her previous doctors were running out of options; however, Linda had watched a documentary featuring Dr. Bishay’s work, and she made contact with him after finding him on social media.

Although she was told she would need to ‘apply’ to have the surgery both for funding and to be cleared for the operation, she steadfastly did so and waited two years to have her 3D printed sternum implanted by Dr. Bishay—making her case the third in Britain (and fifth internationally) to undergo such a procedure.

Scan shows Ms Edwards’ ‘collapsed’ sternum before she underwent the operation

“I woke up from the operation feeling terrible and, at one point, I thought I had died, but I am feeling better every day,” she said, also mentioning that the doctors told her to take it easy and even joked with her about not falling over because she had so much money’s worth of metal in her body to protect now.

“I still feel numb because I am on a lot of drugs, but the main thing is my ribcage doesn’t keep shifting about,” explained Linda. “It feels incredible I have had an operation as advanced as this. I feel like I’ve got my life back.”

“It’s priceless. I can hold my granddaughter and that’s the best feeling in the world.”

Dr. Bishay and his team were able to open Linda’s chest again while being careful to avoid any trauma to the previous bypass area or her heart.

“It’s fantastic to see Mrs. Edwards is doing extraordinarily well given the complexity of the procedure she has undergone,” said Dr. Bishay. “My team and I removed Mrs. Edward’s original breastbone and inserted the custom-built prosthesis.”

“The plastic surgery team, led by Mr. Haitham Khalil, harvested several muscle flaps to cover all the extensive components of the prosthesis, a fundamental step in this operation,” continued Dr. Bishay. “Fortunately, complications such as those experienced by Mrs. Edward’s following previous heart surgery are rare but are notoriously difficult to manage.”

While 3D printing is an amazing technology spawning countless, fascinating inventions, we would still be going a bit far to say such processes have changed the world; they have, however, changed the lives of many patients already, worldwide—with some receiving chest implants and titanium 3D printed sternums, and even composite sternums and rib cages. What do you think of this news? Let us know your thoughts! Join the discussion of this and other 3D printing topics at 3DPrintBoard.com.

Linda Edwards, and her granddaughter, Sienna

[Source / Images: Daily Mail]

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3D Printing Africa: South Africa’s 3D Printing Sector

If there is one country Africa that has seriously ventured into the 3D printing sector with active participation, it is South Africa.

Since 2012, the country at the located at the bottom of the African continent has covered significant ground in developing along with the 3D printing technology. Many international renowned 3D printer manufacturers and suppliers have set up a base engaging several local South African companies in their reseller programs and through distributorship deals. There are over fifteen companies in South Africa directly involved in 3D printing services and such a number is a good one from an African perspective.

3D printed Jawbone implant

South Africa is relatively well developed when compared to other African states and this propels an appetite for advanced technology and so it has been comparatively easy for the development of a 3D printing landscape in South Africa. And they have been proud pioneers in the development and implementation of the technology. In 2014, South African doctors successfully completed jawbone replacement surgery using 3D printed titanium bones and at that time it was the second time such an exercise was done anywhere in the world.

South Africa’s Aeroswift 3D printer

On top of the previously mentioned success story, South Africa through the Council for Scientific and Industrial Research (CSIR) in partnership with Aerusud, an aviation manufacturing company have built one of the world’s biggest printers under a project dubbed Aeroswift. The printer has capability to print tiny items to large customized parts as tall as 2m. The other beauty is the use of titanium powder which lets parts be used for aerospace.

Another 3D printing development worth mentioning is the creation of South Africa’s very own 3D printer: the Robobeast. This a 3D printer made in South Africa by South Africans and a world class home grown solution, something Africa needs for true inspiration. To my understanding, the printer is considered to be a competitive machine on the market and this makes it worthwhile to mention this.

South Africa’s 3D printing ecosystem has enjoyed a thriving community of enthusiasts and designers and this has been supported by a local tech site called Hypertext which has published creation stories of 3D printed items in South Africa so as to keep abreast with the local development and activities.

From a South African industrial perspective, the availability of 3D printing services is of great importance especially when it comes to customizing spare parts and prototyping. South Africa’s manufacturing space is one of the big benefactors of the technology and it solves the supply chain issue regarding spares considering how far they are from the European Hub.

Robobeast 3D printer

The continuous application of 3D printing technology in South Africa further strengthens the growth of the market and its pretty much definite that 3D printing is and will continue to thrive in this Sub Sahara part of the world. Coming from a neighboring country to South Africa, I believe they have done extremely well and they are a true inspiration in the support and development of the technology. There is great potential from South Africa and they equally can be considered as one of the leading African nation in spearheading the advancement of 3D printing.

Job creation and entrepreneurial support is of paramount importance in Africa and 3D printing is slowly and very surely addressing this as is evident with the South Africa’s technology hub with small initiatives and start-ups emerging with a bias of 3D printing services.

The technology is there and the future is bright for South Africa. In Africa, one can currently look down south for technological solutions to technical problems. From a funding point of view, South Africa has done well to the extent that the Government has made strides to make 3D printing a Government strategy. As they say “Proudly South African” and thumbs up to their 3D printing landscape.

Patient Receives a 3D Printed Rib for the First Time in Bulgaria

Ivaylo Josifov (R) with one of his surgeons

35-year-old Ivaylo Josifov was an active, healthy individual who thought he only had a case of tonsillitis when he went to the doctor recently. A chest X-ray, however, showed that he had a growth in the area of his fifth right rib. It was a congenital disease that could lead to the weakening of the chest and issues like difficulty breathing. Because of the risk that the growth could spread, the best option would be to remove the rib entirely and replace it with an implant. Josifov’s doctors decided to try something that had been done only a few times in the entire world before, and never in Bulgaria – to use 3D printing technology to create a new rib for their patient.

The doctors chose 3D printing because it could guarantee a perfect replica of the original rib shape, both in thickness and curvature. They started by scanning the original bone, then sending the scan to Bulgarian service bureau 3dbgprint. The service bureau prepared the file for 3D printing, adjusting it to be sure that it fit into the chest wall. 3dbgprint then 3D printed the implant using a 3DGence 3D printer.

“Our 3D printers ensure high 3D dimensional accuracy which was crucial in this particular medical procedure,” said Filip Turzyński, Quality Development Manager at 3DGence. “Individually designed rib model allowed for very accurate implementation of the new element in place of the removed bone. Replacing the missing rib with a 3D printed segment with the same shape, curve, width, and thickness was possible with the use of 3DGence 3D printer.”

The new rib was 3D printed using an FDA-approved flexible, durable polyamide.

“When we had the first model ready, we started working on its sturdiness,” said Georgi Tolev of 3dbgprint. “Each consecutive model was analyzed and improved until we attained the perfect 3D print of the rib.”

Before the rib was implanted, 3 mm holes were drilled in it to facilitate broaching and proliferation of connective tissue. The implant was thoroughly sterilized, using ethylene oxide as well as gamma radiation and autoclave at 140ºC. The surgery took place at Tokuda Hospital, and the patient is back to excellent health.

Due to the success of the procedure, doctors are already planning new projects using 3D printed implants. Next, they plan to create an implant of three ribs attached to a sternum.

“This is a new era in thoracic wall reconstruction for patients with tumors that require bone-cartilage structures to be removed,” said Professor Minchev, Head of the Cardiothoracic Surgery Department at Tokuda Hospital. “The material used has proven tissue compatibility and the accuracy of reproduction allows for large chest wall resections and their single substitution with individually designed implants.”

Without 3D printing, doctors would have had a much more difficult time creating an implant that fit perfectly and matched the patient’s original rib. An ill-fitting implant could have led to pain and complications, possibly requiring additional surgery in the future. With 3D printing, however, it was possible to perfectly recreate the original rib, allowing the patient to recover quickly and go about his normal life.

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Dog Recovering After Groundbreaking Surgery to Implant 3D Printed Skull Cap

Patches is a nine-year-old dachshund who, for years, had a small and apparently harmless bump on her head. Recently, however, that bump began growing until it became the size of an orange, and turned out to be cancerous. Patches’ owner was referred by her veterinarian to Cornell University‘s veterinary program, which in turn pointed her toward Michelle Oblak, a veterinary surgical oncologist with the University of Guelph’s Ontario Veterinary College. Oblak had been studying the use of 3D printing technology for dogs.

Patches’ tumor had grown right through her skull; normally for a case like hers the tumor and part of the skull would be removed, and then a titanium mesh would be fitted in place. According to Oblak, the procedure is imprecise, costly and lengthy. However, Patches, who needed about 70 percent of her skull removed and replaced, was a perfect candidate for a new procedure, in which a custom titanium skull cap is 3D printed. According to Oblak, veterinarians in the United Kingdom had performed a similar procedure, though on a much smaller scale.

Patches’ owner, Danielle Dymeck, was nervous about the prospect, but decided to go ahead with the procedure.

“They felt she could recover from this,” Dymeck said. “And to be part of cancer research was a big thing for me — if they can learn something from animals to help humans, that’s pretty important.”

Oblak and her team started by taking a CT scan of Patches’ head, then used several different software programs to digitally cut out the tumor and diseased parts of the skull from the CT image. They then designed the 3D printed replacement, complete with holes for screws to hold it in place, and sent the design to ADEISS, a London, Ontario-based medical 3D printing company, which 3D printed a custom titanium skull cap. It took about two hours to design the skull cap and send it to ADEISS, and the final print was ready in about two weeks.

Oblak also created a cutting guide to follow during the surgery.

“There’s very little room for error,” she said. “We’re talking less than two millimetres or else the plate wouldn’t fit.”

On March 23, the surgery on Patches was carried out. Veterinarians removed the tumor and the affected parts of the dog’s skull, then carefully replaced them with the 3D printed skull cap. The entire procedure took about four hours, and within 30 minutes after waking up, Patches was taking a walk outside.

Oblak hopes to have the details of the procedure, which she believes is the first of its kind in North America, published in the upcoming months. A similar case was treated in Texas earlier this year, but a titanium mesh was used rather than a full skull cap, and tragically, the dog passed away from complications after the surgery. Patches, on the other hand, is doing well, despite the fact that in a separate incident a week after the surgery, she suffered a slipped disk that paralyzed her hind legs. She is in good spirits, however, and otherwise healthy and cancer-free.

“She has a wheelchair that she refuses to use, so she pulls herself around on her two feet, but she’s pretty fast,” Dymeck said. “I feel lucky to be her owner, and she’s still the boss of the house…We called her our little unicorn because she had this bump on her head, but it would have killed her. It’s pretty amazing what they did for my girl.”

Discuss this and other 3D printing topics at 3DPrintBoard.com or share your thoughts below.

[Source/Images: The Province]

SwRI and UTSA to develop 3D printed medical implant for slow-release cancer medication

Researchers at the Southwest Research Institute (SwRI) in San Antonio and The University of Texas at San Antonio (UTSA) are developing a 3D printed implant which can deliver a controlled medicine dosage over several weeks. The device could be used to help treat infections or provide ailment to patients suffering from things like arthritis, cancer […]