SI-BONE Awarded Significant "Across Bones" Patent Allowance

SI-BONE, Inc. (San Jose, California), a medical device company that is pioneering the use of a minimally invasive surgical (MIS) device to treat the sacroiliac (SI) joint announced today that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for broad method claims related to the iFuse Implant System. SI-BONE currently markets the iFuse in the United States and European Union under the iFuse name.

Of considerable significance for SI-BONE, was the breadth of the method claims. These claims include placing an elongated device across a joint from one bone to another, using a guide wire to place the implant, using a device that is rectilinear in cross-section, and a device having an exterior surface to provide bony in-growth. "Because the market for minimally invasive surgical treatment of the SI joint is potentially so significant, this allowance provides SI-BONE with a strong competitive barrier. Additionally, the Company has three dependent claims that further claim square, rectangular, and triangular cross-sections," according to Scott Yerby, Ph.D., Chief Technology Officer, SI-BONE.

Additional Patents For Spinal Implant Technologies Acquired

Titan Spine, a medical device surface technology company focused on the development of innovative spinal interbody fusion implants, announced today that it has acquired two patents related to its current and future surface modification techniques. The first patent protects the company's existing manufacturing process that has been shown to produce superior bone-forming activity when compared to standard PEEK and titanium implant materials during in-vitro cellular studies and has been commercially available in the United States since 2006. The second patent protects Titan Spine's next-generation surface technology that further refines its nano features, which the company expects to produce an even more robust osteogenic response.

AAOS 2012: Novel Lighting Technology Helps Orthopaedic Surgeons See What They Are Doing

Invuity is a rare breed of company. It faces “little to no regulatory barriers,” explains the company’s CEO, Philip Sawyer, at AAOS 2012. “And that enables use to develop multiple products and to react quickly and iterate them.”

Founded seven years ago, its lighting technology was initially developed by an optics expert partnering with an orthopaedic surgeon and researcher. The surgeon was working to develop a less-invasive hip for Zimmer and he realized that lighting problems were holding him back. After about five years, the two men had readied their first product: a sophisticated injection-molded optics device the enables orthopedic surgeons to see into small incisions.

The company has been approached by big orthopaedic companies that report they have spent years in vain trying to develop new lighting technologies similar to the firm’s products. “They come to us and say ‘we quit. We need your help.’” Invuity is now “about three weeks from shipping to one of the biggest spinal players,” explains Sawyer.

The company also markets products for breast surgery (through its own sales force) and for spinal surgery (with its sales force working with distributors). Its products are used in less invasive surgeries, where OR surgeons rely on overhead lights or head lamps and it is very difficult to see as you are operating through smaller and smaller incisions.

It developed a core Eigr technology, which uses injected-molded optics and creates a cool glare and shadow-free light. It is integrated in a clever way with access devices, whether those are retractors or whether it is a coupled to a suction device. And the technology creates a nice pattern of light on the tissue. “It looks more straightforward than it is,” Sawyer says. The technology turns the light and in an optimally efficienty way, transmits it, and it is deflected in a pattern. The light is guided through an advanced polymer and extracted via hundreds of micron-sized parallel structures.

“Each of these [structures] has a unique curve so that there is this redundancy," says Sawyer. That way, if anything enters the stream of light--if it is blocked, there is still a strong pattern of light on the tissue. --Brian Buntz

Smith & Nephew Settles Greek Bribery Charges

Smith & Nephew has agreed to pay the U.S. government more than $22 million to settle charges that the company bribed Greek public doctors over more than a decade.

The government had charged Smith & Nephew's U.S. subsidiary under the Foreign Corrupt Practices Act. The government alleged that the company used a distributor to create a "slush fund" to forward payments to doctors working at government hospitals in Greece in order to win business.

This won't come as a shock to readers of Michael Lewis's book, Boomerang. In the book Lewis claims that Greece has a well known culture of cheating on taxes, bribing public officials and cooking the public books.

The company has committed to pay $22,226,799 in fines and profit disgorgement, maintain an enhanced compliance program, and appoint an independent monitor for at least 18 months to review and report on its compliance program.

Value Pricing Leader IFS Now Marketing Subtalar Implants

Internal Fixation Systems, a Miami, Florida, company founded in 2006, has received 510(k) clearance from the FDA to market its subtalar implants. Made of stainless steel, with a cylindrical shape and tapering on one or both ends, the devices are designed to preserve motion at the ankle joint and deal with arthritis as well as whatever trauma the patient has experienced.

IFS’s CEO, Stephen Dresnick, M.D., says that his firm also currently offers a full line of mini-cannulated screws for small bone fixation as well as a Modular Locking Small Fragment System for treatment of bone fractures and osteotomies.

In describing IFS, Dresnick said that the company takes products that have been around for a long time and made by various companies, such as subtalar implants, and figures out how to make them better. He presents the established designs to his panel of recognized surgeons for analysis and modification and the addition of doctor—recommended enhancements. Dresnick then manufactures and sells the devices for 40% to 60% less than the competition.

“We are a value-priced company,” Dresnick told OTW. “We try to build our products inexpensively. They presently cost too much. Medicare is no longer willing or able to pay separately for implants.” IFS customers include ambulatory surgery centers, hospitals and orthopedic surgeons.

FDA Clears Two New Clavicle Repair Technologies

The FDA has granted 510(k) clearance for two products designed to aid in the repair of the shoulder made by Arnold, Maryland-based Suspension Orthopaedic Solutions, Inc. One product is the Distal Clavicle Fracture Fixation System and the second is the Mid-Shaft Clavicle Plate.

The two devices, made of stainless steel, “can be used in combination for the repair of distal-clavicle fractures,” company CEO Robert S. Collins told OTW. “These two new FDA clearances will expand the availability of our confidence-inspiring solutions for orthopaedic surgeons who treat difficult shoulder injuries, and reflect Suspension’s core mission of bringing meaningful innovation to challenging orthopaedic injuries.”

The Distal Clavicle Fracture Fixation System features Suspension’s patent-pending T-Loc Technology which enables knotless, protected and precisely controlled tension for secure fixation of multiple soft-tissue injuries.

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Tabby Cat Gets Knee Replacement

It is not just humans who are getting knee replacements. A ten-year-old tabby cat named Cyrano, in a medical first, received a new knee last week. Veterinary doctors believe this to be the first feline total knee replacement performed in the U.S.

Doctors from Texas and Washington D.C. were present in the operating theater to assist the three orthopedic surgeons from the North Carolina State University College (NCSU) of Veterinary Medicine in the six hour surgery. The implant, designed and fabricated by an international team of collaborators, was made from dense plastic and a cobalt chromium alloy, using a laser process that hardens metal powder to replicate bones.

"The surgery was kind of a bit difficult, but it went very smoothly," said Dr. Denis Marcellin-Little of NCSU, who led the surgical team, in the January 28 news release.

The cat had previously been treated successfully for bone cancer. But the treatment had left the animal with a painfully damaged knee. The cat’s owner, Sandy Lerner of Upperville, Virginia, sought the knee replacement in an effort to avoid having to amputate the cat's rear left leg. In 2005, Marcellin-Little had performed the world's first surgery to fuse leg implants with a cat's bone tissue, so Cyrano's owner turned to him for help.

Marcellin-Little said the 20-pound tabby's big bones were a plus. "He's already able to stand," he said. "His foot is in the right place, and he can put his foot on the ground. So far, so good. Now we have to be very patient with letting his tissues reattach, and it has to heal slowly."

DePuy Announces Several Advancements In Orthopedic Treatment

DePuy Orthopaedics, Inc. (DePuy) announced the launch of several new advancements in orthopaedics spanning joint replacement, shoulder reconstruction and hip revision surgery, each designed to optimize or streamline procedures, personalize care and provide clinical and economic value.

The announcement was made here at the 79th Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS).

New treatment options include AOX Antioxidant Polyethylene, RECLAIM Modular Revision Hip System, GRIPTION TF Acetabular Augment System, GLOBAL UNITE Platform Shoulder Arthroplasty System and GLOBAL STEPTECH Anchor Peg Glenoid (APG). DePuy is also introducing the latest generation of TRUMATCH Personalized Solutions technology for use with its SIGMA Fixed-Bearing Knee System, one of the most widely used knee systems in the world.

'Our ever expanding portfolio enables us to offer solutions to most of the orthopaedic challenges a surgeon or patient may face,' said Andrew Ekdahl, President, DePuy Orthopaedics. 'Our goal is to provide surgeons and health care institutions with more choices that help fill clinical needs, streamline procedures and personalize treatment. We believe that products that focus on these areas will help enhance care while reducing health care costs.'

Last year, DePuy received several FDA product approvals and clearances, including premarket approval (PMA) for AOX Polyethylene, an antioxidant polyethylene designed for optimal wear resistance and long-term oxidative stability, and the PINNACLE COMPLETE Acetabular Hip System, the industry's first and only ceramic-on-metal hip bearing approved for sale in the United States.

The PINNACLE Cup System, which has more than 10 years of documented clinical success and has been provided for more than one million patients, is the only acetabular cup system on the market with PMA approvals for both ceramic-on-ceramic and ceramic-on-metal bearing options. The PINNACLE Ceramax Ceramic Total Hip System, featuring a new generation of ceramic material, received its PMA approval in 2010. The all ceramic implant is the only device in the U.S. with BIOLOX delta, the fourth generation of BIOLOX ceramic. Its three previous versions have been used in millions of implants throughout the world.[i] The PINNACLE System is now the only acetabular cup system with five bearing options, providing surgeons with a full range of options to meet the clinical needs of their patients.

AAOS 2012 Launches

AOX Polyethylene

Approved for use with the SIGMA Rotating Platform Knee System and LCS COMPLETE Mobile Bearing Knee System, the new AOX Polyethylene delivers an advanced blend of polyethylene resin and a unique antioxidant, COVERNOX, to create a new polyethylene material that is highly efficient in trapping free radicals and scavenging oxygen. By eliminating the annealing or remelting process, AOX Polyethylene delivers oxidative stability and optimum wear resistance without compromising the mechanical properties or strength of the polyethylene.[ii], [iii], [iv] By introducing COVERNOX Antioxidant into the base resin before the polyethylene is consolidated, the process enables the antioxidant to be uniformly dispersed and remain blended, eliminating the risk of outward migration.

Hip Revision Solutions

The RECLAIM Modular Revision Hip System is engineered to deliver a high level of implant strength. This system has been studied extensively through analytic techniques and rigorous laboratory testing and has demonstrated promising capabilities, particularly with respect to construct fatigue strength and torsional stability. The modular design of the RECLAIM Revision Hip System features novel instrument technology that may improve intraoperative handling, flexibility and efficiency. The modularity of the system offers surgeons numerous options to treat a patient's unique pathology while simplifying the instrumentation required in surgery.

DePuy's GRIPTION TF Acetabular Augment System addresses bone defects in moderate to complex acetabular revision surgery using a highly porous structure made from commercially pure titanium; a strong, corrosion-resistant metal that has high surface roughness and a similar elasticity to bone. The GRIPTION TF System offers a wide range of options and configurations for the patient at the time of surgery and is designed to work in conjunction with the full range of PINNACLE Acetabular Cup options.

Procedural Efficiency in Knee Replacement

TRUMATCH Personalized Solutions 2.5i provides enhanced capabilities that aid implant positioning and procedural efficiency. TRUMATCH, which reduces procedure time by up to 35 minutes, [v] is the first system to utilize CT scans and computer software to guide the development and production of femoral and tibial cutting blocks that are individually prepared to match the actual bone surfaces of each patient. The use of CT scans, rather than MRIs, results in improved bone imaging, less scanning time and lower costs. [vi]

Advanced Shoulder Solutions

DePuy is launching two new shoulder solutions. The GLOBAL UNITE Platform System, which treats fractures of the proximal humerus, helps improve tuberosity healing and is the only system that can later be easily converted to a reverse shoulder arthroplasty for treatment of arthritis with a torn rotator cuff. The GLOBAL STEPTECH APG System, has been designed to correct excessive retroversion caused by posterior glenoid bone loss, closely recreate the original glenohumeral joint line, and minimize the removal of healthy bone. The prosthesis incorporates a proprietary step design with an anterior backside surface that is spherical and a posterior backside surface that is conical. This unique dual surface design effectively counteracts posterior loading.

Important Safety Information

The performance of joint reconstruction and replacement products depends on a patient's age, weight, activity level and other factors. There are potential risks, and recovery takes time. People with conditions limiting rehabilitation should not have these surgeries. Patients should consult with an orthopaedic surgeon to determine if joint reconstruction and replacement surgery is appropriate for them.

About DePuy Orthopaedics

DePuy Orthopaedics, Inc., a Johnson & Johnson company, is a leading global provider of orthopaedic devices for hip, knee, trauma and extremities, as well as bone cement and operating room products. It is part of the DePuy Family of Companies, which has a rich heritage of pioneering a broad range of products and solutions across the continuum of orthopaedic and neurological care. These companies are unified under one vision - Never Stop Moving - to express their commitment to bring meaningful innovation, shared knowledge and quality care to patients throughout the world. Visit www.depuy.com for more information.

i] CeramTec. 'BIOLOX delta - Nanocomposite for Arthroplasty: The Fourth Generation of Ceramics.' p. 4.

[ii] Data on File at DePuy Orthopaedics, Inc. WR070300.

[iii] Data on File at DePuy Orthopaedics, Inc. WR070248.

[iv] Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants. ASTM Designation: F648-00

[v] Data on file at DePuy. Operating room time includes preparation, operating room, and turnover time.

[vi] D. White, K. L. Chelule, B. B. Seedhom. Accuracy of MRI vs CT imaging with particular reference to patient specific templates for total knee replacement surgery. Int J Med Robotics Comput Assist Surg 2008; 4: 224-231.

Stryker Hip Suit Isn't Completely Preempted, 5th Circuit Rules

Federal law regulating medical devices doesn't completely preempt the claims of a plaintiff who alleged that a hip replacement product malfunctioned and caused him injury, the 5th Circuit has ruled.

The plaintiff underwent surgery involving the implantation of a Trident hip replacement system in his left hip. The Trident system is manufactured by Stryker Corp. The plaintiff later experienced loosening in the joint which required a surgical revision of his hip replacement.

The plaintiff filed a product liability suit, alleging that contamination of the shell of the Stryker device during the manufacturing process prevented bonding with his bone.

Stryker argued that the plaintiff's state-law claims were completely preempted by the Medical Device Amendments to the Food, Drug, and Cosmetics Act.

The court agreed that the plaintiff's breach of express warranty claims were completely preempted, as well as his claims for strict liability, design defect and negligence insofar as they were premised on failure to warn or a marketing defect.

However, the court concluded that there was no preemption of the plaintiff's strict liability and negligence claims to the extent they were based on manufacturing defects arising from a violation of Stryker's manufacturing practices or those approved by the U.S. Food and Drug Administration.

The court concluded that those claims were "parallel claims" permitted under Riegel v. Medtronic (552 U.S. 312). (See "State law claims over medical devices are preempted," Lawyers USA, March 10, 2008.)

"We ... hold that if a plaintiff pleads that a manufacturer of a Class III medical device failed to comply with either the specific processes and procedures that were approved by the FDA or the [FDA's Current Good Manufacturing Practices] themselves and that this failure caused the injury, the plaintiff will have pleaded a parallel claim," the court said.

The court similarly concluded that there was no preemption of the plaintiff's claims for breach of implied warranty.

Total Knee Replacement Can Be Deferred Using Biologic and Bionic Meniscus Replacement Procedures, Data Show

At American Academy of Orthopedic Surgeons in San Francisco, a group of renowned orthopedic surgeons from around the world gathered to discuss the latest findings for meniscus transplantations. New data on knee joint cartilage and meniscus transplantation presented at the 27th annual Meniscus Transplantation Study Group revealed that the meniscus tissue can be successfully replaced by tissue replacements such as cadaveric allografts, using artificial materials such as polyurethane scaffolds, and using polycarbonate-urethane implants. These advances bode well for all those who have developed knee pain or arthritis and want to avoid a total knee replacement.

The meniscus cartilage is the key shock absorber in the knee joint, and when injured, it is often removed. Loss of this critical structure often leads to joint pain and arthritis. Of the 1.4 million knee surgeries occurring in the United States each year, 98% of them result in the removal of meniscus tissue.

Eight investigators from five different countries presented on the science of meniscus replacement. From the United States, Kevin R. Stone, MD of the Meniscus Transplant Center at The Stone Clinic in San Francisco presented the largest and longest study of meniscus transplantation. The study spanned 16 years of data with approximately 80% success at improving patient pain and function in both pristine and arthritic knees. Many patients were able to return to a wide range of sporting activities after undergoing meniscus transplantation.

Mathew T. Provencher, MD, MC, USN of the US Navy presented data on the biomechanical changes in the knee for soldiers with a new meniscus and an osteotomy realignment procedure. The soldiers' pain was diminished and some were able to return to active duty.

Peter Verdonk, MD of Belgium unveiled a novel artificial meniscus implant made from polycarbonate-urethane. The implant is meant for patients who have a missing meniscus and knee pain, but whose knees are otherwise healthy. The data is preliminary but represents a new bionic approach to cartilage replacement. Dr. Verdonk also described the successes and failures of an artificial scaffold designed to regrow tissue called Actifit. The complication rate is still too high at 20%, but improvements are planned.

The global nature of cartilage loss and arthritis is being addressed and today offers young and old patient solutions that can be performed without removing bone or opening the joint, and permits return to sports.

SOURCE Meniscus Transplant Center