28 янв. 2012 г.

More than half of acetabular components placed are malpositioned, according to a recent study from Massachusetts General Hospital.

Component malposition is associated with the most common reasons for revision surgery including instability, wear and wear-associated loosening, and impingement.

The HipSextant Navigation System (Surgical Planning Associates Inc., Boston) is a mechanical instrument, adjusted on a patient-specific basis, designed to achieve appropriate component alignment. The method was invented and developed by Stephen B. Murphy, MD, of Boston.

A new tracking system enables physicians to determine how a hip or knee implant is interacting with their patients' bodies through use of a radiostereometric analysis device.

The device can help physicians monitor if a replacement implant is wearing down or moving. The implant procedure, according to a Midwest Orthopaedics at Rush news release, also provides a radiostereometric analysis (RSA) registry for implants — allowing researchers to collect data on materials and designs used for hip and knee replacement prostheses.

Scott Sporer, MD, is one of the first physicians in the country to use the new device in all compliant patients, according to the release.

Belgian and French orthopedists determined a new bone-preserving straight, cementless hip stem proved less invasive, preserved bone and performed as well as other hip stems, according to a recently presented study.

Didier Mainard, MD, presented findings from the prospective study at the SICOT XXV Triennial World Congress 2011 in Prague.

“Uncemented stems can have the same good results as the cemented stem,” Mainard told Orthopedics Today in an interview.

Merits of the new stem

Mainard and colleagues theorized a stem coated with a special calcium phosphate called brushite would better preserve bone biology and invented a new uncemented stem that used the material, the Excia implant (B. Braun; Tuttlingen, Germany). The femoral prosthesis is coated proximally with titanium plasma and brushite.

Although computer navigation can increase accuracy in total hip arthroplasty (THA), surgeons using conventional instruments can achieve proper component positioning without additional costs and time, according to a presentation at Orthopedics Today Hawaii 2012.

“Ideal component position can be achieved with conventional instruments and a consistent surgical technique, so I see no reason to use computer navigation, at least on a regular basis,” Michael D. Ries, MD, said during his presentation.

Templating and positioning

Proper component positioning, Ries said, starts with patient positioning. He noted that the most important thing is to have the pelvis in a secure position.

A recently published review found that approximately 1 in every 200 patients undergoing hip replacement will develop a venous thromboembolism before hospital discharge when current venous thromboembolism preventive medications are used.

The findings were recently published in the Journal of the American Medical Association and also revealed that 1 in every 100 patients undergoing knee replacement will develop a venous thromboembolism (VTE).

“These estimates are of value to individuals and organizations seeking to evaluate institutional VTE event rates against contemporary benchmarks,” Jean-Marie Januel, RN, MPH, and colleagues wrote in their review. “Our above-mentioned rate estimates provide these contemporary benchmarks.”

27 янв. 2012 г.

Until recently, the cost of orthopedic and spine devices weren't inhibitory for providers, even though 700 percent mark-ups on these devices were the norm. Surgeons were able to select their preferred implants and payor reimbursement would cover the cost. However, with a recession at hand and incentives for lowering the cost of care, more surgeons are looking for high quality implants at the lowest cost; that's where small orthopedic and spine device companies like The Orthopaedic Implant Company come in, which offers implants to providers at their retail price.

"We founded the company about a year ago to meet the needs of surgeons who were frustrated with the high cost of orthopedic implants and our healthcare system's inability to pay for [them]," says Itai Nemovicher, president and co-founder of The Orthopaedic Implant Company. "If we tried to do this five years ago, it probably wouldn't have worked out, but now as physicians and hospitals are forced to align their interests, part of which is cost containment, there is a lot more care on the surgeon's side to use cost-effective implants."

26 янв. 2012 г.

The Pinnacle® Hip System (DePuy Orthopaedics, Inc.) was the first cementless acetabular cup to feature a design allowing varying combinations of acetabular liners. Though other designs have since mimicked this approach, Pinnacle has been established as a class leader and an extremely reliable clinical device. Within my clinical practice over the past 10 years, I have implanted more than 3,000 of these acetabular cups, and I continue to use it for all total hip arthroplasty (THA) patients, both primary and revision.

The variable liner cup system allows surgeons to use Pinnacle on almost every patient that requires a THA. In older patients, for example, a polyethylene liner may be the most appropriate bearing choice. In high-demand patients, a hard-on-hard bearing (ceramic-on-ceramic, ceramic-on-metal, metal-on-metal [MoM]) may be the best choice. The variable liner cup also allows for simplified reoperations in the event a revision is required. In fact, there is no need to replace the entire cup when a liner can easily be switched out to accommodate other designs—lipped, lateralized or face-changing liners—in cases of instability. The Pinnacle Hip System uses Variable Interface Prosthesis taper technology to allow for multiple liner options. Additionally, Pinnacle enables me to refine a single surgical technique with which I am very familiar, and one that has provided consistently positive results for my patients. This has the potential to minimize any variability in outcomes that could be introduced by adopting different implant systems, which I would use less frequently, for different patients.

25 янв. 2012 г.

In 2012, UK-based Stanmore Implants is preparing to take on part of the world (the UK, Europe, and the United States) with a patient-specific knee system that integrates robotics. Although there are technologies that address patient-specific implant creation, the twist on the Savile Row system is that it integrates such an implant with robotics. “Everything from the planning phase through to the implant manufacture and surgical execution is personalized to the patient,” says Graeme Brookes, managing director of computer-assisted surgery and integrated technologies at Stanmore Implants. As a result, accuracy and reproducibility is introduced into the surgical procedure. The implant is a unicondylar knee replacement, which means it preserves more tissue than a total knee replacement.

As metal-on-metal hip implants continue to be scrutinized, here's the latest from Jim Dickinson in MD+DI's Washington Wrap-Up:

"A review of clinical trials, observational studies, and registries produced limited evidence on comparative effectiveness of various hip implant bearing combinations, according to an open source British Medical Journal report by researchers from CDRH and universities in the United States and Australia. “Results do not indicate any advantage to metal-on-metal or ceramic-on-ceramic implants compared with traditional metal-on-polyethylene or ceramic-on-polyethylene bearings,” the study concludes....They say they systematically reviewed the evidence as part of that project to determine the short- and long-term outcomes reported by patients undergoing hip replacement and the rates of revision after using implants with various bearings."

Recovery of Orthopaedics Companies Remains Slow

In a daily letter from Canaccord Genuity, analysts reiterated a statement made last summer about the end of the glory days in orthopaedics. That is not to say that things won’t get better, but don’t expect to see improvements until the economy as a whole recovers.

Three Manufacturers Who Look Good:
  • China Kangui Holdings. The China-based orthopaedics company continues to grow through its strong product pipeline.
  • NuVasive. The acquisition of Impulse Medical could help strengthen NuVasive’s business strategy.
  • OrthoFix. The company already surpassed analyst revenue expectations for Q4 2011.

Two Takeaways from the Canaccord Analysts:
KFx Medical Corporation Awarded New Medical Devices Patent

KFx Medical Corporation today announced that it was granted a new patent from the United States Patent and Trademark Office: U.S. Patent No. 8,100,942 broadly covering knotless double row rotator cuff repair. The new patent bolsters KFx Medical’s patent portfolio and highlights KFx Medical’s innovation in the orthopaedic and medical devices industry.

In 2011, an anonymous party filed a request that the Patent Office re-examine KFx’s first and seminal patent (U.S. Pat. No. 7,585,311) which also broadly covers knotless double row rotator cuff repair. The Patent Office rejected all arguments made by the anonymous party and completely upheld the KFx patent.
Medtronic, Inc. Announces 510 Clearance For Aquamantys SBS 5.0 Sheathed Bipolar Sealer For Spine Surgery

Medtronic, Inc. announced that it has received 510 clearance from the Food and Drug Administration (FDA) for the Aquamantys SBS 5.0 Sheathed Bipolar Sealer, a new addition to the spine portfolio of the Company’s Advanced Energy business. The SBS 5.0 Sheathed Bipolar Sealer gives spine surgeons the ability to optimize speed and continuity in surgical cases by providing hemostatic sealing capabilities for both incised soft tissue (e.g., cut muscle) and epidural veins with a single device. Like other devices in the Aquamantys line, the SBS 5.0 uses Transcollation technology, a combination of radiofrequency energy and saline that has been shown to reduce blood loss and improve visualization when used during spine procedures. Reductions in blood loss during surgery have been linked to reduced blood transfusion rates and decreased surgical time. 

24 янв. 2012 г.

38 Orthopedic & Spine Device Company Executive Moves in 2011

Former president of medication delivery company Baxter Healthcare Peter Arduini was named CEO of orthopedic device company Integra LifeSciences. He replaced Stuart Essig, who became chairman of the company's board.

Wright Medical Group's chief technology officer Frank Bono is no longer with the company.

Interventional Spine named Stephen T. Colaiezzi senior vice president. He previously worked with Stryker, Medtronic and Aesculap.

Leslie H. Cross, former CEO of DJO Global, was elected to the Alphatec Spine board of directors as the non-executive chairman of the board. While with DJO Global, Mr. Cross helped the company's revenues grow from $30 million-$966 million.

Ascendx Spine recently appointed Maria Pilar Debelius-Kinsey as the company's new sales and marketing manager in Europe. She has served in management and sales positions at Medtronic and SpineVision.
Популярно об остеопорозе:

12 New Research and Development Projects Announced by Orthopedic Companies

Here are 12 orthopedic and spine technology research and development projects.
DePuy Orthopaedics recently announced its plan to spend $7 million on research and development equipment for its company by 2014. At the same time, it announced plans to spend $20 million on manufacturing equipment.
Eminent Spine, a Georgetown, Texas-based medical device company, has recently completed and released the results of a study of its King Cobra Anterior Cervical Plate in which none of the 25 patients experience complications.
Israel-based medical device company Expanding Orthopedics has launched a post-market study in Europe to assess its XPED Expanding Pedicle Screw System for spinal fusion. The study will enroll up to 50 patients and test the usability of the products for 24 months postoperatively.
Stryker Biotech reps get off clean in off-label marketing suit

Federal prosecutors drop all charges against the 2 remaining Stryker Biotech sales reps after the company pleaded guilty to charges of off-label marketing and agreed to pay a $15 million fine.

Federal prosecutors dropped all charges against the 2 remaining Stryker Biotech sales managers charged with illegal off-label promotion and of lying to the FDA.
FDA issues guidance on IDEs for knee cartilage repair/replacement devices and drugs

The FDA issues new guidance on proper submissions for investigational device exemption and investigational new drug applications for products intended to repair or replace knee cartilage.

The FDA this week issued new guidance on getting clearance for clinical trials of products intended to repair or replace knee cartilage.

The guidance covers devices, biologics and hybrid products, outlining required items to include in submission documents for investigation device exemption or investigation new drug applications.
Tennessee Hip Replacement Patient Files Suit Against DePuy For Alleged Debilitating Injuries

Kathryn E. Barnett of the national plaintiffs’ law firm Lieff Cabraser Heimann & Bernstein, LLP, announced that Paul McCurley of Chattanooga, Tennessee, has filed a lawsuit against DePuy Orthopaedics, Inc., and its parent company, Johnson & Johnson, Inc., for the injuries he suffered after his DePuy Pinnacle metal on metal hip implant failed.

The lawsuit charges that DePuy knew that the Pinnacle metal on metal hip generated unusual and dangerous levels of metal debris accumulation in many patients and presented abnormally high risks of early failure. Despite notice of these alleged problems and defects, DePuy continued to promote and sell the Pinnacle metal on metal hip, and has not recalled the product.

On January 17, 2006, McCurley underwent a right total hip replacement procedure usi
Normal shoulder arthroscopic exam

DePuy suspends distribution of custom devices following FDA warning

Posted on : 23 January 2012

Johnson & Johnson subsidiary Depuy Orthopaedics has decided to stop selling all custom devices following an FDA letter warning. The FDA requires DePuy to file new new PMA or 510(k) applications for several components including:

1. PFC Sigma Knee System with titanium components and Global Advantage Shoulder System with titanium heads;

2. PFC Sigma Knee System components, sizes 2.5, 7, and 8;

3. PFC Sigma Knee System, 30 mm – 40 mm thick inserts;

23 янв. 2012 г.

Medtronic Announces 510(k) Clearance for the Aquamantys SBS 5.0 Sheathed Bipolar Sealer for Spine Surgery

Medtronic, Inc. (NYSE:MDT) announced today that it has received 510(k) clearance from the Food and Drug Administration (FDA) for the Aquamantys® SBS 5.0 Sheathed Bipolar Sealer, a new addition to the spine portfolio of the company’s Advanced Energy business.

“We are excited to offer surgeons this new addition to our ever-growing spine portfolio of advanced energy products”
Аптечный рынок Казахстана: итоги первых 9 месяцев 2011

Согласно данным Розничного Аудита ГЛС в Казахстане™, по итогам трех кварталов 2011г. розничный аптечный рынок страны в натуральном вы-ражении сократился на 4% и составил 331,581 млн. упаковок. В денеж-ном выражении (без учета ДЛО) рынок страны продемонстрировал пози-тивную динамику: 2% в казахских тенге и 3% - в долларах. В оптовых ценах рынок достиг 572,366 млн. долл. (83,690 млрд. тенге), в розничных – 699,243 млн. долл. (102,242 млрд. тенге) (рис.1). Средняя стоимость упаковки в розничных ценах составила 2,11 долл., тогда как годом ранее - 1,97 долл. По итогам девяти месяцев 2011г. уровень потребления ГЛС на душу населения составил 42,53 долл. (в 2010г. – 41,94 долл.).
New Score Can Tell Surgeons How They Preform on The da Vinci(R) Robot

Jan. 22, 2012 -- A new assessment system has been developed by a team of researchers to more reliably predict whether surgeons are ready to operate on patients using the da Vinci robot. The new technology, called MScore, provides more precise analysis of actual surgical performance, which has been shown to be difficult to accomplish using common training approaches.

Prior to the introduction of da Vinci simulation training, the only option for most robotic surgeons was to learn on patients, animals and simple plastic models. Such training methods rely on a subjective assessment from proctors rather than precise measurement of movement and actions.