By DON LONG BB&T National Editor
JIM STOMMEN, BB&T Executive Editor
and LYNN YOFFEE, BB&T
"We're going to focus on the cutting edge in biologics," said Allan Mishra, MD, summarizing the primary goal of a new orthopedics society that he has been instrumental in forming and officially launched this week.
This means, he said, new orthopedic approaches that will tend to avoid "the cutting" by using emerging biologics that may substitute for surgery and other invasive approaches.
Speaking to Biomedical Business & Technology by phone through the hubbub of the annual meeting of the American Academy of Orthopaedic Surgeons (AAOS; Rosemont, Illinois) in Las Vegas in late February, Mishra said that the Clinical Biologic Orthopaedic Society (CBOS) is the first organization to put sole emphasis on this emerging sector.
The society's "narrow focus," he said, will be "to discover, design, develop and test biologic solutions for orthopedic problems."
Large orthopedic conferences, he said, usually will feature presentations "on either spine or hip or knee, and each has a biologic session in it put in the back corner on Sunday morning at 8 o'clock."
Thus the CBOS intends to heighten this emphasis and support increased awareness and collaboration among orthopedic researchers bringing new patient-centered biologic approaches to the field.
Mishra, of the Stanford University Medical Center (Stanford, California), has collaborated with Pietro Randelli, MD, from the Universit degli Studi di Milano (Milan, Italy), to launch the organization; they co-chaired its inaugural meeting before the AAOS conference and were named as its "presiding founders."
There are 12 other founding members, with Italy, Japan and India joining the U.S. membership to emphasize the group's global reach. And Mishra emphasized that international participation will be a key characteristic of the society.
That emphasis, he said, will help to push a "flat earth" sort of collaboration, with the Internet speeding the exchange of information about new research in the field, and pushing more frequent cross-disciplinary approaches.
A society statement reporting the group's launch listed several examples of research areas to be pursued: "stem cell therapy for osteoarthritis and other musculoskeletal conditions; platelet-rich plasma [PRP] injections for chronic tendonitis, disc regeneration, and accelerated healing; molecular and cell biology and biomaterials for tendon-to-bone healing; and recombinant bone morphogenic proteins to repair fresh fractures."
"Current research," according to the statement, "suggests that these biologic treatments may be used alone or in combination for optimal effect."
Development of the organization has been "percolating" for some months, Patti Davis, a publicist serving as executive director of the CBOS, told BB&T, with the AAOS meeting providing the opportunity official unveiling.
The organization was originally set to be named the Biologic Orthopaedic Society, but the term "Clinical" was added at the inaugural meeting to highlight the types of research being pursued by the members.
Thus, Mishra told BB&T that on the bench-to-bedside continuum, the society will not emphasize the "cell-culture" proof-of-concept work but treatments that have the greatest likelihood of reaching patients – therapies, as he put it, "on the horizon rather than 10 to 20 years away" and "something patients can look forward to, that practicing physicians can look forward to."
Medicine has for several years been predicting that metal and plastic will be supplanted by natural materials, and Mishra said the time for turning those predictions from talk to reality is now at hand.
"Regenerative medicine and biologics are pushing orthopedics into new and exciting directions," Mishra said. "But until we formed the CBOS, no one group represented a vibrant research community that is hard at work developing these applications for orthopedic use."
Mishra's specialty is sports medicine, and he said this sector is "leading the way" in the development of biologic therapies. "We're leading in these approaches right now, a lot of athletes interested, a lot of doctors," he said, repeating the emphasis on "cutting-edge" approaches that avoid "cutting."
Mishra shares an interest with Randelli in the use of PRP, and Rendelli has developed a technique for using PRP as an augmentation in arthroscopic rotator cuff repair.
Membership in the CBOS will be by invitation only and will consist primarily of researchers who have had been successful in publishing their work, Davis told BB&T.
Others participants in the organization will be "tiered," and Mishra said that the society is still working out the specifics for various types of participation.
Besides its website, at www.BiologicOrtho.com, CBOS also has plans to launch an online journal. The society said that in its initial stage it is privately funded.
In addition to Mishra and Randelli, the other founding members of the society include Steven Arnoczky, DVM, Michigan State University (East Lansing); Scott Boden, MD, Emory University (Atlanta); Neal El Attrache, MD, Kerlan-Jobe Clinic (Los Angeles); Lisa Ann Fortier, DVM, PhD, Cornell University (Ithaca, New York); Mary Beth McCarthy, University of Connecticut Health Center (Farmington); William Maloney, MD, Stanford University Medical Center; Augustus Mazzocca, MD, University of Connecticut Health Center; Mitsuo Ochi, MD, PhD, Hiroshima University (Japan); Scott Rodeo, MD, Hospital for Special Surgery (New York); Anthony Romeo, MD, Rush University Medical Center (Chicago); Vijay Shetty, Dr. L.H. Hiranandani Hospital (Mumbai); and Yuji Yasunaga, MD, PhD, Hiroshima University.
With MAKO's system, results are as planned
The premise behind MAKO Surgical's (Fort Lauderdale, Florida) approach to minimally invasive knee procedures is simple: What you plan is what you get.
And that's what the company highlighted at AAOS, where it debuted its RIO Robotic Arm Interactive Orthopedic System and Restoris MCK MultiCompartmental Knee System after receiving FDA clearance of the products in December.
Maurice Ferré, MD, president/CEO/chairman of the company, ebulliently told BB&T that the AAOS gathering "was kind of our 'coming out' party."
Ferré said the traffic at MAKO's booth on the exhibit floor was constant. "We have taken the floor by storm," he said in a phone interview from that busy exhibit area. "We're kind of the talk of the town."
Asked how surgeons were reacting to the new systems being exhibited by the company, Ferré said, "When they put their hands on the robot, they have an epiphany."
He said the RIO system's passive robotic arm means "you can truly introduce minimally invasive surgery" to the knee-replacement sector.
Ferré said that for unicompartmental and bicompartmental knee systems, "you need perfect placement," and that's what RIO and the Restoris implants provide. He described Restoris as "the first robotic-enabled implants, specifically designed to be put in with a robotic system."
The RIO system provides patient-specific, 3-D modeling for pre-surgical planning. "As surgeons use the robotic arm to resurface the knee for placement of the implants," the company said in a statement, "RIO provides real-time, inter-operative visual, tactile and auditory feedback, enabling a high level of precision and optimal positioning of the implants."
MAKOplasty makes partial knee resurfacing available to a larger patient population. It previously was only possible to perform such resurfacing on the inner, or medial, portion of the knee. With the RIO system and Restoris MCK components, it now can be performed on both the medial and patellofemoral, or top, portion of the knee.
MAKO is well-positioned to gain serious traction in a space dominated by such big players as DePuy (Warsaw, Indiana), Stryker (Kalamazoo, Michigan), Smith & Nephew Orthopaedics (Memphis, Tennessee) and Zimmer (also Warsaw).
"We hold the key patents in orthopedic robotics," said Ferré. The company's IP portfolio includes more than 250 licensed or owned patents and patent applications relating to computer-assisted surgery, haptics, robotics and implants.
Declaring that robotics "has come of age," he said MAKO thinks it can address fully 50% of the existing total knee replacement (TKR) market. That's especially true, Ferré said, given today's economic travails. "With the kind of resurfacing approach we offer, the recovery period is much shorter," so patients undergoing a MAKOplasty procedure miss less work.
He noted that one of the difficulties in building clinician interest in minimally invasive approaches is that unicompartmental procedures are difficult to do, "but now, with robotics, they can do it."
Ferré likened the process to a paint-by-numbers project. "Via CT [computed tomography], the clinician creates 'virtual walls' you have borders, and this keeps you from drawing or painting outside the lines."
He said that the orthopedic sector has seen "a lot of progress with materials and implant design, but not a lot of progress in terms of delivery systems."
Enter the RIO System, which Ferré said targets a market of 15 million persons with osteoarthritis of the knee. Of that market, only 10% currently are done as unicompartmental procedures. "We feel we can address 350,000 procedures," he said.
"We think in particular of those over 70," who are reluctant to face knee replacement surgery, he said. "Now, here's an implant to won't be as difficult for them to endure the rehabilitation. That's a great patient population for us."
The company has come a long way in a relatively short period of time. It was founded in November 2004 and received clearance for the first version of its Tactile Guidance System (TGS) a year later. Two enhanced versions of TGS were released in 2008, then came the Restoris Unicompartmental Knee System, cleared by the FDA last June.
December 2008 brought approval of the second-generation robotic system, the RIO, along with the Restoris MCK.
As of year-end 2008, a total of 782 MAKOplasty procedures had been conducted, with 17 sites up and running. "We have two years worth of data on some cases," Ferré said, and seven journal articles have just been accepted for publication.
Seven of those studies were reported in the February issue of The American Journal of Orthopedics.
Among the authors was Martin Roche, MD, chief of orthopedic surgery at Holy Cross Hospital (Fort Lauderdale), who performed the first MAKOplasty procedure back in June 2006 and has been a big fan of the approach since he first learned of the company from "one of the financial guys" who had left the hospital to join the fledgling firm.
"We were their first site to do MAKOplasty," he told BB&T, adding that the procedure "gives results" for both clinicians and patients. He noted that patients "go home much quicker" than with conventional knee replacement approaches.
"I look on it as a very smart software system that lets me put in a knee that I can micro-adjust in order to put it in perfectly," Roche said. "What I plan is what I consistently get."
He has now done about 180 MAKOplasty procedures, including doing his first bi-compartmental knee procedure with the RIO system in January, and says the new system and new knees from MAKO likely will mean he'll increase his percentage of knee replacement procedures done via MAKOplasty from 10% to 20% of the total.
Roche said patients are "very excited" about the concept of doing their procedures robotically, seeing it as an advancement of technique that can improve their respective outcomes.
Poised for gains in a crowded knee-replacement market, the company has had success in the financial markets, raising $91 million last year from an IPO in February and a private placement in October.
"We've seen this coming," Ferré declared. "The future is all about precision surgery and the use of robotics."
KFx's new approach to rotator cuff repair market
Common sense would hold that surgeons fix torn tissue, rather than making it worse. But that's exactly what happens when orthopedists endeavor to fix partial articular sided tendon avulsion (PASTA) tears – a type of rotator cuff tear that commonly causes shoulder pain. The remaining attached supraspinatus tendon is usually fully torn from its natural position and then reattached.
"When it's 50% torn, the clinician tears the rest away in order to repair it," Tate Scott, chairman/CEO of KFx Medical (Carlsbad, California), told BB&T. "As you can imagine, clinicians don't like to tear away good tissue. But it's a degenerative disease and they know what the end of the story is. It's going to go on to become a full-thickness tear eventually; most do."
KFx has just launched PASTAFx Anchor System, which is designed to repair partial rotator cuff tears, avoiding the need to fully tear the tendon first.
"The PASTAFx system enables you to put the anchor through the tendon and then into bone without removing the tendon," Scott said. "That's why it's different. It makes the doctor more comfortable with repairing early because they don't have to tear the tendon."
Surgeons have been using anchors to do repairs for decades. But the problem with most anchors comes down to size. Most are about 4 mm.
"If you screw that through the tendon, you've just further denigrated the tendon," he said. "Yet if they don't remove the tendon to repair it, then they can't get a big enough anchor in place to be worthwhile. Our system goes in through the tendon at 3 mm. Once it's under the bone, it expands to a 10 mm wingspan."
Picture a hollow-wall expanding anchors, such as a molly bolt or toggle screw, and you get the idea.
"We saw the need for this product and we believe PASTAFx will become a new standard of care," Scott said.
FDA 510(k) clearance for PASTAFx was obtained several years ago, but the company has made some modification so that it's more user-friendly before commercially launching the product this month.
PASTAFx will be the second flagship product for this small company. The first, SutureCross Knotless Fixation System, is used for arthroscopic, double-row rotator cuff and some PASTA repairs.
Privately held KFx is venture-backed. Investors include Alloy Ventures, Charter Life Sciences, Arboretum Ventures, Montreux Equity Partners, and MB Venture Partners.
For now, it intends to produce PASTAFx independently.
"We manufacture it ourselves in Carlsbad," Scott said. "Our focus and dream here is true treatment of disease states. We're not a product company. We're a procedures company."
He added, "We're sufficiently funded and we've got a great team of venture investors; we follow a capital-efficient model. We're not a company built on putting 60 direct sales people in the field. We are focused on disease states and proving, with good clinical results, that we can manage that," he said.
With about 400,000 rotator cuff injuries reported each year in the U.S., the company has a fairly broad market to address. Just back from the American Academy of Orthopaedic Surgeons (Rosemont, Illinois) meeting in Las Vegas, Tate said the launch of PASTAFx went well.
"You always feel like you've done things right when clinicians take a look and say 'Gosh, I've been searching for a product for PASTAs' and you identify an unmet need," he said. "They really light up, because their goal is to do right by their patients."
Jonathan Ticker, MD, an assistant clinical professor of orthopaedic surgery at Columbia University's College of Physicians and Surgeons (New York), commented on the PASTAFx approach.
"As surgeons, we are conflicted with these types of tears. On the one hand, we are trained to preserve healthy tissue; however, we know the likely outcomes of this progressive disease once it begins," Ticker said. "I am seeing a growing body of literature advocating the trend toward earlier intervention to remediate PASTA lesions given the natural progression of rotator cuff disease."
He added, "The KFx PASTAFx is a valuable tool in the arsenal of shoulder surgeons to preserve healthy tissue and achieve optimal outcomes regardless of what kind of tears are encountered in rotator cuff pathology."
Advantages of TKR even in elderly patients
A study presented at AAOS indicated that knee replacement surgery can improve the quality of life even for very elderly patients. The study found that patients in their 80s can benefit both physically and socially from total knee arthroplasty (TKA), once thought too risky for the very elderly.
"As patients are living longer, there is an upward trend in the demand for quality of life among the elderly population," said Edsel Arandia, MD, lead author of the study and an orthopedic surgeon at Philippine Orthopaedic Center and a fellow at Singapore General Hospital.
"As patients age," he said, "debilitating diseases like arthritis of the knee begin to develop. We conducted this study to determine the viability of TKA in octogenarians and to learn whether their quality of life improves after TKA."
Arandia and his team reviewed data from 128 patients older than 80 years of age who underwent knee replacement surgeries at Singapore General Hospital between October 1998-December 2006.
The results were measured using two quality-of-life scales, the SF-36 and the Oxford Knee Score, which assign scores to elements of physical and emotional health, such as physical pain, social functioning, vitality and physical functioning.
When the researchers compared the patients' preoperative scores to their postoperative scores up to two years following surgery, they found the quality of life scores had risen "significantly" during the postoperative period.
"In our institution, many surgeons are still skeptical to perform TKA in the very elderly, since few data or studies pertaining to the gains of TKA versus the complications and risks that can occur with surgery in elderly patients exist," Arandia said. "This study shows that with the advent of new technology and techniques in both orthopaedics and geriatric medicine, total knee arthroplasty in the very elderly population is very safe and offers significant gains in their quality of life."
Among other study findings presented at the meeting:
• Using a common mechanism to score activity levels after hip surgery, researchers found that the majority of patients who underwent a procedure to resurface arthritic hip bones consented to surgery with unrealistic expectations regarding outcome.
While many patients hoped to return to skiing, jogging, ballet or tennis after surgery, most instead continued to experience limits on activities due to pain and stiffness. They were, however, able to regain the ability to participate in low-impact activities that increased their quality of life. The researchers recommend pre-surgical counseling to set expectations.
• There is evidence that a patient who suffers a shoulder injury is likely to have a family history of such injuries. Family members, even distant relatives who have suffered tears to the rotator cuff, the muscles and tendons that hold the top of the upper arm bone in place, appear to create an increased risk for others on the same family tree to also develop a torn rotator cuff. This risk extends out to third-cousin relationships.
• Researchers found that if any relative, even distant, suffered a rotator cuff injury, there was a greater likelihood of suffering a rotator cuff injury before age 40.
• Patients who undergo hip replacement surgery often complain of stiffness and occasionally suffer severe muscle spasms, limiting surgical recovery and lowering post-surgical quality-of-life. When Botox is injected into spasming or stiff muscles around the hip, all of the trial patients showed increased hip range of motion, decreased pain, fewer (or zero) muscle spasms and were able to walk more normally with little or no limp.
Researchers chose to investigate Botox after reading of similar success the drug showed in knee replacement surgery.
DePuy launches femoral head and fracture plating systems
DePuy Orthopaedics (Warsaw, Indiana), a leading producer of devices for joint replacement and trauma, reported the launch of the aSphere M-Spec Femoral Head, a new metal hip bearing option that potentially reduces cumulative wear by 80% and associated ion release by 77% compared with conventional metal-on-metal technology.
The announcement was made during at AAOS
DePuy said this advancement in metal bearing technology is the result of its continued investment in bearing design and manufacturing. Precision-contoured aSphere heads approximate the shaping that occurs during the in-the-body run-in wear phase.
The company said this new design incorporates a wear-resistance zone, so patients may experience a substantial decrease in metal wear debris and ion release when compared to conventional metal-on-metal designs.
The aSphere head, combined with DePuy's TrueGlide technology, facilitates a more fluid range of natural motion and up to 159 degrees range of motion, the company said. The aSphere head was cleared for marketing by the FDA in December, adding another advanced option to DePuy's Pinnacle Hip Solutions bearing system.
All DePuy metal-on-metal bearings feature TrueGlide technology, which the company said "enhances performance with smooth, natural motion and less friction."
Advanced tribology is the science behind this innovation, it said, and is the main reason for improved wear resistance over conventional technology.
TrueGlide technology optimizes the diametrical clearance and surface finish of the implant, allowing the body to create a thin film of synovial fluid, enabling bearing lubrication and reducing wear. The result, according to DePuy, is a smooth, more fluid range of natural motion.
"In addition to improved wear and ion release, the Pinnacle System's aSphere M-Spec Femoral Heads provide optimized head-to-shell ratios, which may enhance stability and long-term performance," said Mark Hanes, PhD, worldwide director of research at DePuy Orthopaedics.
The company said the aSphere head is compatible with its complete line of advanced femoral stems to provide surgeons greater flexibility based on their preferred technique and the patient's anatomy.
David Floyd, U.S. president of DePuy Orthopaedics, said, "The aSphere head is the latest example of our commitment to innovation that continues to optimize our premier high-stability and low-wear solutions."
DePuy also reported the launch at AAOS of the Anatomic Locked Plating Systems (A.L.P.S.) for hand and distal fibula fractures.
The company said the A.L.P.S. Hand Fracture System and A.L.P.S. Composite Locking Plate System "offer anatomically-designed titanium plating technology utilizing low-profile, high-strength plates. These plates provide the flexibility of in situ contourability to mimic the patient's natural anatomy and multiple screw and fixation options."
The company said the low-profile design helps minimize discomfort and soft tissue irritation.
DePuy said the A.L.P.S. Hand Fracture System is its first plating system for complex fractures of metacarpal and phalangeal bones. It said the system's "uniquely contoured plates mimic the anatomy of the fingers and are available in five styles that can be used to treat a wide range of fractures, using titanium alloy and cobalt chrome screws for strong and stable fixation."
The company said the low-profile design, strength and stability of the A.L.P.S. Composite Locking Plate System "make it particularly well-suited for distal fibula procedures, which often involve complex fractures and minimal tissue coverage." The small-fragment plate features a bulleted tip at the proximal end to facilitate insertion under the muscles of the lower leg.
Both plating systems come pre-loaded with DePuy disposable and color-coded Fixed Angle Screw Targeting Guides (F.A.S.T. Guide inserts). The Guides direct the trajectory of the drill-bit through the plate to facilitate accurate screw placement after drilling the hole. DePuy said this has the potential to save time in the operating room, since no intra-operative assembly of the guides is required.
"The A.L.P.S. family of plating solutions enables surgeons to provide treatment to suit both the anatomy and complexity of the fracture," said Gordon Van Ummersen, worldwide president, DePuy Trauma and Extremities. "We'll continue to build on this innovative and versatile locked plating technology through the launch of additional anatomic modules over the next year."
DePuy also launched two new high-flexion implants in the company's Sigma Knee System: the Sigma High Performance (HP) Partial Knee and the Sigma CR150 High-Flex Knee. The company also unveiled customized patient instrumentation, TruMatch Personalized Solutions, for knee replacement.
The company said the Sigma HP Partial Knee System is the only partial knee solution on the market that can replace the medial, lateral and patellofemoral compartments while providing low wear and up to 155 degrees of flexion. The tibial implants utilize a moderately cross-linked, oxidatively stable polyethylene.
The Sigma CR150 High-Flex Knee is the company's first high-flexion, cruciate-retaining knee replacement. DePuy said the Sigma CR150 System combines high function and conformity while accommodating up to 150 degrees of flexion. This implant includes oxidatively stable polyethylene and a highly polished cobalt chrome tray.
DePuy said it also continues to expand its portfolio with developments such as TruMatch Personalized Solutions. "This instrumentation comes as a result of extensive research and development efforts and is designed to improve implant positioning and increase procedure efficiency," the company said.
From the exhibit floor
• Conmed's (Utica, New York) Conmed Linvatec business unit launched six new devices in its Sports Medicine and Capital product lines at the meeting.
The products include:
– Hip Arthroscopy System. The Conmed Linvatec hip system includes the Bio Mini Revo suture anchor, suture passers, including the extended length Spectrum MVP, and a full line of extended length accessory instrumentation. Extended-length shaver blades, burs and a disposable hip kit, along with a slotted cannula system, offer surgeons a "comprehensive line of innovative solutions for arthroscopic labral repairs during hip arthroscopy," the company said.
– Paladin Suture Anchor. This suture anchor is the latest addition to Conmed Linvatec's rotator cuff repair-related product portfolio. The Paladin will be available in two sizes, and is offered with a self-drilling punch-tap for one-step insertion during shoulder repair. The product utilizes the company's bioabsorbable, self-reinforced poly lactic acid, demonstrating its commitment to bringing products to market with a "superior biomaterial advantage." The Paladin Suture Anchor is pending 510(k) approval.
– Zen Wireless Footswitch and Adaptor, which eliminates the need for wires from the footswitch to the power console units and incorporates the power of Zigbee communications technology to provide three-pedal control of Conmed Linvatec's power control consoles and handpieces. "This is important in a variety of orthopedic, spine and ENT applications because it creates valuable space within the operating room without the need for special hardware," the company said. The footswitch and adaptor are pending 510(k) approval.
– ReAct Arthroscopic Shaver Blades. Unlike conventional shaver blades that only cut by rotation, these new shaver blades have the ability to reciprocate while rotating. The company said the ReAct blade's hub design provides "a more aggressive and faster cutting action with unsurpassed resistance to clogging. This could potentially reduce the length of time for certain surgical procedures."
– Mpower 2 Battery Power System, the latest in the company's next-generation battery power systems for large and small bone orthopedic and spine surgical applications. It has been designed with Conmed Linvatec's sealed system to ensure a long period of reliable performance. New features include quick connect collet and intuitive mode switch allowing for ease of use.
– VP1600 Digital Documentation System, which expands on the company's leadership within true "High Definition" products, and is a cost-effective solution for surgeons vs. traditional pc-based image capture systems, it said.
• Medartis (Kennett Square, Pennsylvania) introduced its new Aptus Adaptive Watershed Plating System.
The company said the new system has been made available in limited release and received "positive reviews" from surgeons who have used it.
• Merge Healthcare (Milwaukee), a medical imaging solutions provider, reported the release of Cedara ProPlanner 3.1, which it said was "built on years of work with orthopedic providers and vendors to offer a comprehensive digital solution for joint arthroscopy, trauma and deformity correction."
It said this newest release also gives health IT application vendors the ability to integrate these capabilities into existing applications such as PACS or EMRs.
Cedara ProPlanner contains features such as semi-automatic calibration, user-defined measurements and image stitching that help decrease the time and cost of planning for surgeons and vendors. A long-standing Merge Healthcare customer is preparing to launch this product in Asia to meet surgeon demand for increased workflow efficiency, accurate and detailed digital plans, and potential increased profitability.
Merge said Cedara ProPlanner 3.1 offers internationalization and branding support for OEM partners, who can integrate it into existing PACS solutions, add it to a DR/CR modality or run it as a standalone workstation.
• NDS Surgical Imaging (NDSsi; San Jose, California), a provider of medical visualization solutions for surgery suites, introduced new visualization tools that allow clinicians and surgeons in an operating room to view diagnostic images from radiology locations.
Radiology Imaging for the Surgical Environment or RISE, uses the company's Visualization and Informatics technologies to provide a solution that enables real-time, interactive consultation for medical professionals in the OR.
• RTI Biologics (Alachua, Florida), a processor of orthopedic, dental, surgical specialties and other biologic implants, launched two new biologic implants for use in sports medicine surgeries. Matrix HD, the first RTI dermis graft for sports medicine, and fresh-stored osteochondral (OC) talus allograft, an expansion of RTI's fresh OC line, are both now available through RTI's representatives and distributors.
Matrix HD heralds RTI's entry into the augmentation graft market and is the first crossover implant opportunity from the 2008 merger of RTI and Tutogen Medical. Matrix HD is acellular human dermis sterilized through Tutoplast, using the same processing technology that has been successful for membrane implants used in hernia, dental and other surgical specialties for more than 30 years.
RTI said it is expanding its fresh-stored OC line with the introduction of the fresh-stored OC talus allograft. The fresh-stored OC talus enables surgeons to resurface cartilage defects in the ankle with mature hyaline cartilage and healthy subchondral bone in a single procedure.
• Salient Surgical Technologies (Portsmouth, New Hampshire) unveiled the Aquamantys Epidural Vein Sealer (EVS) bipolar device. The company said the EVS is designed to address the challenging anatomy in minimally invasive spine surgery and is the latest product introduction on its Aquamantys platform.
The EVS employs Transcollation advanced energy technology to "significantly reduce bleeding in hard-to-reach areas," according to Salient. "Reducing blood loss improves visualization for the surgeon, can result in improved clinical outcomes for the patient and may result in lower costs to the hospital."
The innovation of the EVS, the company said, is the ability to deliver Transcollation technology through miniaturized electrodes, which provide direct and precise compression of epidural veins around critical structures. The EVS is used with the same Aquamantys System Generator as Salient's standard 2.3 and 6.0 Bipolar Sealer devices.
"Our substantially increased investment in research and development has begun to yield results with the launch of the EVS," said CEO Joe Army. "The EVS represents the latest in a series of innovations designed to improve patient outcomes and reduce hospital costs that we have planned for 2009."
• Smith & Nephew's Orthopaedic Reconstruction & Trauma (Memphis, Tennessee) business has released the Visionaire Patient Matched instrumentation for use in total knee replacement surgery.
The Visionaire's technology uses a patient's MRI and X-rays to create custom surgical instrumentation for use with the S&N portfolio of high-performance knee implants. By using instruments designed from each patient's anatomical data, surgeons can accommodate the unique shapes and angles of the joint while precisely aligning the implant.
The disposable, patient-specific instruments help surgeons eliminate multiple steps and valuable minutes from knee replacement surgery, thus decreasing the risk of infection as well as the amount of time a patient is under anesthesia.
• Smith & Nephew Endoscopy (Andover, Massachusetts) reported the launch of the Osteoraptor Anchor for repair in the hip and shoulder. The company noted that during 2009, surgeons will perform an estimated 15,000 labral repair procedures in the hip joint and an estimated 185,000 procedures for the shoulder. Labral repairs are necessary when the labrum, the fibrous cartilage ring that rims the joint socket, tears or becomes stretched due to impingement or acute injury.
Damage to the labrum in the hip may be a source of chronic pain and may also contribute to osteoarthritis. In the shoulder, this damage can lead to instability where the upper arm bone slips out of the socket. In standard procedures, surgeons reattach the labrum to the bony socket of the joint using small anchors and suture.
S&N said the new Osteoraptor Anchor is the first hip anchor to use polylactic acid hydroxyapatite (PLLA-HA). The key ingredient, hydroxyapatite, is a mineral found naturally in bone. The company said studies have shown that the presence of HA increases the anchor's strength and introduces chemicals that promote the formation of a strong bond between the anchor and the bone surface.
The anchor is available in 2.3 mm and 2.9 mm sizes. The 2.3 mm anchor for use in the hip, is the smallest bioabsorbable hip anchor on the market, according to S&N Typically, surgeons use multiple anchors to repair labral tears. The company said the anchors' size gives the surgeon the ability to place them more precisely within the tight confines of the joint space.
• Zimmer Holdings (Warsaw, Indiana) highlighted its exhibit space with an interactive Trabecular Metal Technology experience. The company also showcased several new product launches that span the company's portfolio, and the Zimmer Institute hosted presentations at an on-site education theater.
The Trabecular Metal Technology experience on the second floor of the massive Zimmer exhibit provided visitors with an interactive environment to explore the structure, function and physiology of what the company said is "the only tantalum-engineered porous implant material." Exclusive to Zimmer, Trabecular Metal Technology "replicates the structure of cancellous bone more closely than other implant materials and is conducive to more normal bone formation and bone in-growth," it said.
The product launches included:
– DeNovo NT Natural Tissue Graft for the treatment of focal cartilage defects in a variety of anatomic locations.
– The Zimmer Natural Nail system, which features anatomic-shaped implants designed to match the normal anatomy of long bones and achieve excellent fixation.
– The Zimmer Periarticular Elbow Locking Plate System, which offers anatomically contoured plates, optimized screw positions and options to address most fracture types.
– The new Trabecular Metal Glenoid, the only glenoid component with Zimmer's exclusive porous technology for biological fixation.
The Zimmer Institute hosted an on-site theater and "sawbones laboratory" sessions featuring presentations on a number of Zimmer products, including the Zimmer Gender Solutions Patello-Femoral Joint System, the M/L Taper Hip Stem with Kinectiv Technology; the NexGen LPS-Flex and LPS-Mobile Bearing Knee; and the Zimmer Natural Nail system.