Posted on | December 5, 2013 | No Comments
BioPen to rewrite orthopaedic implants surgery (Health Canal)
A handheld “bio pen” developed in the labs of the University of Wollongong will allow surgeons to repair damaged and diseased bone material by delivering live cells and growth factors directly to the site of injury, accelerating the regeneration of functional bone and cartilage.
Researchers from the UOW-headquartered Australian Research Council Centre of Excellence for Electromaterials Science (ACES) have developed the prototype BioPen that will give surgeons greater control over where the materials are deposited while also reducing the time the patient is in surgery.
Delivery of stem cells and/or growth factors into the injury site is currently through injection using a biomaterial carrier.
Posted on | December 1, 2013 | No Comments
LAWYERS SET TO EARN $1 BILLION IN DEPUY ASR DEAL (Orthopedics This Week)
Lawyers representing over 8,000 plaintiffs in DePuy ASR hip lawsuits are recommending that their clients accept Johnson & Johnson’s (J&J) $2.5 billion settlement offer.
For good reason. According to a November 25, 2013 New York Times article by Barry Meier, the lawyers stand to earn almost $1 billion.
Those lawyers have publicly praised the deal and described it as an “innovative plan” that will compensate patients who had to have hip revision surgery. After the lawyers’ fees, Meier reported that patients will get about $160,000 on average to compensate for their pain and suffering. There is also a $475 million pool for added payments to the most severely injured. In addition, J&J agreed to pay claims from private insurers and agencies like Medicare seeking to recover the costs of operations and other medical treatments related to the device.
Posted on | November 29, 2013 | No Comments
Brazil’s Big Opportunity Can’t Wait for This Health Care Leader (Daily Finance)
Read S+N Press Release here
Remember when emerging markets were destined to make investors rich? It hasn’t worked out that way in 2013 — not after China’s leading stocks have disappointed and Brazil’s economy has slowed down from the lofty growth projections of a few years ago. Those can’t-miss growth opportunities just haven’t panned out yet for the most part.
Yet the potential is there in emerging markets, no doubt. Leading medical device firms have made big acquisitions in developing nations, led by Medtronic and Stryker in China over the past year. Orthopedics rival Smith & Nephew isn’t shying away from the emerging markets game, either. It’s beefed up its own exposure abroad lately with its purchase of a quarter of the business of Brazilian device firm Politic Saude. But is this the right move for this medical device giant in its emerging markets push?
Smith & Nephew makes a move
Emerging markets have been a big boon for Smith & Nephew, which has been hit with the headwinds of stiff competition and pricing pressures that have slowed many leaders in the medical device industry. Even with the company’s shaky financial performance recently, however, this stock has been on a roll for investors over the past two years.
Posted on | November 27, 2013 | No Comments
MOM HIPS: BANNED IN BRITAIN (Orthopedics This Week)
The United Kingdom has banned metal-on-metal hips.
The UK’s National Health Service (NHS), following new guidelines issued by the country’s National Institute for Health and Care Excellence (NICE) has banned most metal-on-metal hip implants in all hospitals funded by NHS. Few of the implants would meet the new standards set by NICE. The ban will affect nearly all manufacturers of the devices.
The UK’s public health system is fully funded by the NHS, so every hospital falls under the ban.
Posted on | November 26, 2013 | No Comments
With back pain becoming increasingly more common, the clinical implications of disc research are greater than ever before. Therefore, these efforts should focus on disc preservation, which is less invasive than fusions, according to a presenter, here.
Gunnar B.J. Andersson, MD, PhD, noted in his plenary lecture at the Philadelphia Spine Research Symposium that the disc can be preserved for a while. “But, the primary cause [of degeneration] is genetic,” he said.
The number of fusions performed in the United States and the procedure’s cost has increased, and since fusion is an invasive approach it is more urgent than ever to find a cure for degenerative disc disease (DDD).
In 2011, the cost for a fusion increased to $44,000, he said. This underscores why disc research should continue and focus more intently on the preservation of the spinal disc. Hopefully, such a strategy will affect the degenerative process early on, at the stage when it first starts to be visible on MRI and well before it is detected on radiographs of the spine, Andersson said.
“In 2011 there were about 450,000 fusion operations in the United States — an enormous number. If we could replace some of them by a biologic treatment method, obviously it would have a huge impact on society,” said Andersson, who is the Section Editor of Basic Science & Technology for Orthopedics Today, said.
But, “we are not even close” on a biologic solution to disc preservation, he noted.
Andersson discussed limitations in the diagnosis and treatment of DDD and the problems that researchers face in understanding its etiology. One possible approach to solving this dilemma, he said, is to alter the effect the modifying factors of age, mechanical issues, obesity and others have on a person’s discs.
Researchers should also keep in mind that compared to any of these disc modifying factors, genetics may play an even larger, unalterable role in DDD. Secondary conditions may also impact the disc’s health, Andersson said.
He reviewed the mechanical, biochemical and nutritional theories of DDD.
“Whether the disc is the primary source of back pain or not, to me, is not that important in terms of research into retaining the disc because I know for sure it is a secondary source of back pain.” Andersson said.
“We do need better diagnostic methods…and we need noninvasive solutions,” he said. – by Susan M. Rapp
Andersson GBJ. Disc research: what are the clinical implications? Presented at: Philadelphia Spine Research Symposium. Nov. 6-8, 2013. Philadelphia.
Disclosure: Andersson has no relevant financial disclosures.
- In my opinion, the possibility that an infectious agent may be a cause of degenerative disc disease (DDD) requires serious investigation.Dr. Andersson mentioned the observation that stomach ulcers were due to bacteria. Indeed, this observation revolutionized our understanding of the pathogenesis of this common condition. I should point out that initially, the concept that ulcers may be due to an infectious agent was treated with humor and disbelief by many authorities. Now, of course, we know that the claims of the Australian scientists/physicians who researched the concept were totally valid and their work has revolutionized the treatment of this ubiquitous condition.
New studies have shown that many of the tissues of the body are contaminated with bacteria. Moreover, the bacteria co-exist with the host (mammalian) cells. Based on these new understandings, the possibility is that bacteria may reside in cartilage and the nucleus pulposus and co-exist there with the resident chondrocytes and notochordal cells. Just like stomach ulcers, which can be activated by stress, a change in local conditions may activate the bacteria to proliferate; bacteria which live in communities with each other and control their own numbers and species-type, now dramatically change. Aside from invoking an inflammatory response and tissue degeneration, a biofilm may form which would protect the organisms from invading white cells and allow the organisms to reside in the tissue protected from antibiotics. If any aspect of this concept is valid, it would completely change our approach to treatment of DDD and back pain.
- Irving M. Shapiro, BDS, PhD
- Department of Orthopaedics
Thomas Jefferson University
Posted on | November 26, 2013 | No Comments
NEW DATA ON 3-HOUR OUTPATIENT PARTIAL KNEE REPLACEMENT (Orthopedics This Week)
Don’t fear the outpatient experience, says the largest study ever on outpatient partial knee replacement. Robert S. Gorab, M.D. is the chief medical officer at the Hoag Orthopedic Institute (HOI) in Irvine, California. He tells OTW, “Our study, just published in The Journal of Arthroplasty, found that after unicompartmental knee arthroplasty (UKA), day of surgery discharge for appropriate patients can be both safe, efficient and even increase patient satisfaction. We took 160 consecutive patients with appropriate risk profiles and performed all the procedures on an outpatient basis.
We found that there were no readmissions, no re-evaluations for nausea, no falls, and no acute post-surgical complications. We had a broad age range—people in their 40s all the way up to 83 years of age. And the average length of stay was less than three hours! The success of these procedures can largely be attributed to the strong educational process that we have at our facility.
Posted on | November 20, 2013 | No Comments
Arthrosurface Stemless Shoulder Arthroplasty Hits 10 Year Mark (Providence Journal)
Arthrosurface Incorporated (www.arthrosurface.com), a developer of less-invasive joint restoration and resurfacing systems, performed its first US stemless shoulder resurfacing in 2003. The Company continued to expand the technology and introduced the stemless total shoulder system in 2011 using the world’s first aspherical humeral implant combined with an off-axis inlay glenoid. Other Orthopaedic companies have only recently started to explore stemless total shoulder designs. However, these designs still require removal of the humeral head and implantation of spherically shaped implants that are not anatomic by design.
Steve Ek, CEO commented; “We realized 10 years ago that the traditional stemmed shoulder arthroplasty presented unnecessary technical challenges to surgeons while attempting to accurately restore the humeral head position in space. In addition, we pioneered the concept of aspherical geometries to restore humeral head anatomy. The combination of a stemless design and the aspherical head geometries is what makes the Arthrosurface shoulder uniquely anatomical and is a cornerstone of our intellectual property in the shoulder portfolio.”
Posted on | November 17, 2013 | No Comments
This year saw several important acquisitions in the orthopedics sector.
The largest transaction in the very active orthopedic device area was Stryker’s proposed acquisition of publicly held Mako Surgical Corp. for $1.65 billion (13x revenues and 183% over the value of Mako on the day before the transaction was announced). Mako produces orthopedic surgical systems and knee and hip implants for treating early- to mid-stage osteoarthritis, and its key product is the RIO surgical system, which includes a robotic arm that assists surgeons to precisely insert orthopedic implants.
With Mako under its umbrella, Stryker will be able to use its own implants with Mako’s RIO system, thereby broadening the adoption of RIO while defending itself as the orthopedic products of competitor. The pioneering company in robot-guided surgical procedures is publicly held Intuitive Surgical, whose da Vinci Surgical System has gained mainstream acceptance. It is estimated that in 2012 there were 400 da Vinci surgeries. The growth potential for robot-assisted surgeries is believed to be great, as only 2% of surgeries worldwide were robot-assisted last year. Also, robot-assisted procedures have the potential to benefit patients, hospitals, insurance companies, and other healthcare payors because they may reduce costs by shortening hospital stays and recovery time and reducing the level of medication and rehabilitation.
Posted on | November 17, 2013 | No Comments
STRYKER/ORTHOVITA INSIDE TRADERS PLEAD GUILTY (Orthopedics This Week)
After Stryker Corporation acquired Orthovita, Inc. in 2011, the feds charged former Stryker marketing executive Mark Foldy with insider trading.
On October 7, 2013, Foldy, along with Mark Cupo, John Lazorchak and Michael Pendolino plead guilty to the charges. On November 13, 2013, two brokers, Lawrence Grum and Michael Castelli each admitted to two counts of conspiracy to commit securities fraud. Grum also plead guilty to four counts of securities fraud and Castelli admitted to five counts of securities fraud, according to the office of New Jersey District Attorney Paul Fishman.
According to a November 14, 2013 MassDevice story, Grum and Castelli allegedly acted on tips from Foldy about the impending $316 million deal for Orthovita. The brokers were high school friends of Foldy. The scheme generated $1.7 million in illegal profits and kickbacks.
Posted on | November 17, 2013 | No Comments
VIETNAM TESTING KNEE STEM CELL TREATMENT (Orthopedics This Week)
According to Vietweek, Vietnam is one of the few countries in the world doing clinical trials to treat knee osteoarthritis (OA) using stem cells taken from a patient’s fat tissue. Two of the hospitals conducting the trials say the procedure has proved effective so far.
Bui Hong Thien Khanh, M.D., head of orthopedics at the Ho Chi Minh City (HCMC) Medicine and Pharmacy University Hospital, said that, as of last January, his hospital had performed the trials on 21 patients with OA of the knees.
Doctors use a needle to harvest about 100cc of patients’ abdominal fat and extract stem cells from the tissues with a centrifuge. They also remove some of the patients’ blood and place it in the centrifuge to get platelet-rich plasma. They then put the stem cells and platelet-rich plasma under a low-energy laser before injecting the mixture into the degenerative joints.
Khanh said both the plasma and low-energy laser help activate dormant stem cells, which, after activation, can differentiate into cartilage cells to replace the lost ones, and stimulate the damaged cartilage tissues to regenerate.
Nguyen Van Kinh, Ph.D., an advisor at Bach Mai’s Vietnam Gene Therapy Center, said in the most severe cases, it (the stem cell therapy) only helps the cartilage tissues develop and release a fluid to improve the knee joint’s lubrication and relieve pain, and cannot return the knee to its original structure. The health ministry has also allowed People’s Hospital 115 and Van Hanh General Hospital in HCMC to carry out trials for two years starting in April.
Posted on | November 15, 2013 | 1 Comment
THE BLOOD INJECTIONS THAT MIGHT TRANSFORM ORTHOPEDIC (The New Yorker)
Chris Waddell has been an élite athlete for more than two decades. He has won twelve medals in downhill skiing, including five golds, in four Paralympic Games events; he was a world-record-holding wheelchair track sprinter; and, in 2009, he became the first paraplegic to climb Mt. Kilimanjaro, using his arms to power a customized four-wheeled cycle. Even at forty-five, Waddell, who was paralyzed in a college skiing accident, has a muscular, sharply defined upper body, the product of thousands of hours of training.
But all this exercise has taken a toll. Several years ago, Waddell’s shoulders began to ache constantly. Last year, he tore a rotator cuff while weightlifting, and began having trouble lifting himself into and out of his wheelchair. “I had no control,” he said. “When I was getting off a couch, I had to marshal all of my strength.”
Waddell, who lives in Park City, Utah, went through a range of treatments. “I tried a lot of rehab, I did a lot of exercises, I had a cortisone injection,” he said. “I wasn’t making any progress.” Several orthopedists told him he would have to accept being in pain for the rest of his life.
Posted on | November 14, 2013 | No Comments
Amedica Files for IPO (press release)
Amedica Corporation, a Salt Lake City, Utah-based silicon nitride orthopedic and spine implant company, has filed with the U.S. Securities and Exchange Commission to raise up to $35 million in an initial public offering (IPO). The company, which was founded in 1996 and booked $23 million in sales for the 12 months ended June 30, 2013, plans to list on the NASDAQ under the symbol AMDA.
Amedica initially filed confidentially on September 23, 2013. The company had previously filed for an IPO in May 2007 before withdrawing three months later. JMP Securities is the only listed bookrunner on the deal. No pricing terms were disclosed.
Earlier this year, Amedica released the Valeo II AL interbody fusion device in the United States; and signed a distribution agreement with K2M to get its silicon nitride-based implants into the European market.
Posted on | November 13, 2013 | No Comments
- Recall Costs
- 94 Percent
- Federal Suits
- Sulzer Settlement
- Chicago Jury
Johnson & Johnson (JNJ) will pay more than $4 billion to resolve thousands of lawsuits over its recalled hip implants in the largest settlement of U.S. legal claims for a medical device, three people familiar with the deal said.
The accord will resolve more than 7,500 lawsuits in federal and state courts against J&J’s DePuy unit, said the people, who requested anonymity because they weren’t authorized to speak publicly about the settlement. Patients who have had hips replaced claimed in the cases that the implants were defective.
Johnson & Johnson’s DePuy unit recalled 93,000 implants in 2010, including 37,000 in the U.S., after more than 12 percent failed within five years.
China begins new knee OA cell study to evaluate a human adipose-derived mesenchymal precursor cell therapy
Posted on | November 13, 2013 | No Comments
KNEE OA CELL THERAPY TRIALS IN CHINA (Orthopedics This Week)
Renji Hospital in Shanghai, a tertiary hospital affiliated with Shanghai Jiao Tong University School of Medicine, has given approval for a Phase IIb clinical trial for ReJoin. ReJoin is a human adipose-derived mesenchymal precursor cell therapy bio-engineered for knee osteoarthritis (KOA) by Cellular Biomedicine Group, Inc.
The trial will test the safety and efficacy of intra-articular injections of autologous (patient’s own) ReJoin formula in order to reduce inflammation and repair damaged joint cartilage.
“The approval of our Phase IIb clinical trial design is a major milestone for Cellular Biomedicine Group,” said company CEO William Cao, M.D. “We are pleased to receive such expeditious validation from Renji Hospital and its regulatory offices of our Phase I/IIa data package, which showed a high safety profile and positive results reflected by the osteoarthritis indices and pain indices.”
Cao said that, in addition to Shanghai’s Renji Hospital, several more leading hospitals will be joining this multicenter double-blind Phase IIb clinical trial. He expects enrollment of patients in the study to begin during the fourth quarter of 2013. Cellular Biomedicine Group, Inc. develops proprietary cell therapies for the treatment of certain degenerative diseases. According to Cao, the firm’s developmental stem cell, progenitor cell, and immune cell projects are the result of research and development by scientists and doctors from China and the United States.
Posted on | November 12, 2013 | No Comments
Maetta Sciences announced that FDA clearance has been obtained for a cobalt chrome orthopaedic implantable device manufactured with its proprietary metal injection molding (MIM) technology. This project was developed in close collaboration with one of the company’s large OEM customers. The company will commence production of this device for market introduction this fall.
Maetta believes that this is the first time FDA clearance is obtained for an implantable device made by MIM. (Source: Maetta Sciences Inc.)
Posted on | November 11, 2013 | No Comments
Zimmer, OrthoSensor Ink Co-Marketing Partnership (press release)
Agreement Provides VERASENSE Knee Technology for use with Zimmer Knee Systems
OrthoSensor, a leader in intelligent orthopaedics, and Zimmer Holdings, Inc., a global leader in musculoskeletal health, announced today that they have entered into a co-marketing partnership which will marry Zimmer knee systems with OrthoSensor’s VERASENSE Sensor-Assisted Technology.
“While we currently lead the industry in Patient Reported Outcomes (PROMs) with our NexGen Knee, we know that component placement and soft-tissue balancing are critical to patient satisfaction and implant longevity,” said Jeff McCaulley, Zimmer Reconstructive President. “As such, Zimmer is committed to offering the widest array of intelligent instrumentation to assist surgeons. Our collaboration with OrthoSensor, and the ability to leverage real data in soft tissue balancing with VERASENSE, should allow for even more satisfied patients.”
Posted on | November 5, 2013 | 1 Comment
INTEGRA GOES “HOLLYWOOD” INTERVERTEBRALLY (Orthopedics This Week)
The FDA has issued a 510 (k) clearance for Integra LifeSciences Holding Corporation’s Hollywood NanoMetalene Interbody Device (IBD). The IBD is to be used primarily for transforaminal lumbar interbody fusion.
According to the October press release, “The PEEK-OPTIMA polymer used in the Hollywood NanoMetalene IBD underwent a proprietary high-energy, low temperature surface process that created a titanium coating around the implant, including the graft window. Company officials say that the ultrathin coating does not affect postoperative imaging and the surgeon’s ability to view the operative area and determine the extent of the vertebral body fusion.”
In its press release the company reported that it expects to begin a controlled U.S. release of the interbody device this year. Kirt Stephenson, president of U.S. Spine at Integra LifeSciences, stated, “Surgeons prefer the surface characteristics of titanium and the mechanical properties and radiolucency of PEEK-OPTIMA, and the Hollywood NanoMetalene IBD offers a treatment option that incorporates both benefits into one device.”
Posted on | November 5, 2013 | 1 Comment
JOINT ARTHROPLASTY READMISSIONS TOP 5% (Orthopedics This Week)
A little more than 5% of patients who undergo total hip and knee arthroplasty return to the hospital within 90 days for an unplanned readmission, according to a study published in October in The Journal of Bone & Joint Surgery.
Benjamin Zmistowski, from Thomas Jefferson University Hospital in Philadelphia, conducted the study. He and his colleagues examined the incidence, causes, and risk factors for readmission following total joint arthroplasty. They used data from an institutional arthroplasty database for 10,633 admissions for primary arthroplasty (5,207 knees and 5,426 hips) performed from January 2004 through December 2008. They identified patients requiring an unplanned readmission within 90 days of discharge from the same database.
As reported by the publication Doctor’s Lounge, the researchers found that in 5.3% of total joint arthroplasties there were 591 unplanned readmissions within 90 days of discharge. Joint-related infection was the most common cause of readmission, followed by stiffness. Independent predictors of readmission within 90 days included black race, male sex, discharge to inpatient rehabilitation, longer hospital stay, unilateral replacement, age, decreased distance between home and the hospital, and total knee replacement.
“It is imperative that measures to limit these complications, through appropriate prophylactic measures and prevention of increased duration of hospital stay and discharge to an inpatient facility, be effectively implemented to limit the physical and psychological impact of readmission on patients and the financial burden to society,” the authors wrote.
Posted on | November 2, 2013 | No Comments
NASS Executive Committee Responds to Washington Post Article (NASS rebuttal)
The October jobs report and third-quarter gross domestic product are expected this week.
Posted on | October 31, 2013 | No Comments
Artificial knee joints tailored for Chinese people (English.News.CN)
Chinese people’s joints wear out too, but replacement implants have, on occasion, been too large. Now a team of 21 experts from France and China’s Sichuan Provincial People’s Hospital in the southwestern city of Chengdu have co-developed artificial knee joints based on the bone proportion of Chinese people.
Artificial knee joints, domestic or imported, used to be produced according to the skeleton structure of Europeans, said Wang Yue, orthopedic doctor of the hospital. “Westerners are generally larger than Chinese in terms of body size, which is why patients less than 1.4 meters (about 4.6 feet) tall in China cannot find appropriate artificial knees,” Wang said.
Former French Prime Minister Jean-Pierre Raffarin said at a press conference that the two countries would further cooperate on the development of artificial joints to meet the growing demand of Chinese people.keep looking »