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FDA Clears New Spinal Implants from X-spine

X-spine Systems Inc. is adding two new devices to its product portfolio. The U.S. Food and Drug Administration has cleared the company’s Calix PC Spinal Implant System and the Axle PEEK Interspinous Fusion System.


The Calix PC system is described by the company as an intervertebral body fusion device consisting of titanium-coated PEEK (polyetheretherketone) implants. The product is coated with a special plasma to improve the adherence of titanium to its surface and minimize its risk of rejection in the body.


“The selective coating of plasma-sprayed titanium to a polymer substrate in an intervertebral implant is potentially the most important development in intervertebral fusion technology since the introduction of PEEK implants a decade ago,” X-spine President and CEO David Kirschman, M.D., noted in a news release. “The Calix PC provides the benefit of a metallic surface while preserving the desirable qualities of PEEK, namely bone-equivalent modulus and radiolucency.”


Laboratory tests indicate the Calix PC system has a 79 percent greater resistance to rejection (within the body) than non-plasma-coated devices. Such an improvement in rejection, executives claim, ultimately could help expedite patients’ recovery from implant surgery.


X-spine’s Axle PEEK system, meanwhile, expands on the 8-year-old firm’s Axle line of interspinous fusion devices. The new product incorporates an insert made from an implantable-grade PEEK polymer, also known as PEEK-OPTIMA, a semi-crystalline thermoplastic that exhibits a combination of strength, stiffness and toughness as well as biocompatibility. PEEK-OPTIMA also repeatedly can be sterilized without the degradation of its mechanical properties. These characteristics have helped the material to become more popular with companies developing implants, particularly those that manufacture such products as finger implant stems, femoral stem prostheses, acetabular cups, prosthetic hips, spinal cages, suture anchors and ligament fixation washers as well as bone screws and pins.


And, of course, interspinous inserts. With clearance of its Axle PEEK system, X-spine now can offer surgeons a better variety of materials for spinal fusion devices.


“The proprietary modular design of the Axle system allows for different types of inserts to be placed in the interspinous space,” Kirschman said. “Surgeons can now decide if PEEK polymer or oxide-blasted titanium alloy is the best choice for their needs and indications. This type of innovation exemplifies our philosophy of putting the best options into the hands of the spine surgeon and patient.”


Headquartered in Miamisburg, Ohio, X-spine Systems develops and manufactures spinal implants.


Ivivi Orthopedic HealthTakes Steps to Rebrand


Ivivi Orthopedic Health Inc. has found a new identity. The Seattle, Wash.-based firm has changed its name to Amp Orthopedics Inc. to reflect the company’s therapeutic and commercial focus in the field of orthopedic specialties, particularly post-operative indications and musculoskeletal diseases.


“Amp Orthopedics reflects our company’s strategy to bring critical change to the treatment paradigm for pain management in orthopedic indications by providing safer, more effective and non-narcotic treatments,” Amp CEO Eric Dremel said.


Amp Orthopedics develops non-invasive products for the treatment of postoperative pain and edema. The products use a non-thermal pulsed radio frequency (PRF) technology to enhance the body’s natural healing pathways and accelerate recovery from surgery. PRF induces a non-invasive pulsed magnetic field to accelerate the biochemical cascades involved in tissue repair and regeneration, according to the company. Pulsed magnetic field therapy has been used successfully to treat delayed union fractures, chronic wounds and post-operative pain and edema, Amp executives claim. It also is used to better manage symptoms of knee osteoarthritis.


Amp’s PRF technology received CE Mark approval in the European Union in December 2007 for the promotion of wound healing, reduction of pain and treatment of post-operative edema. The U.S. Food and Drug Administration (FDA) gave its blessing to the technology the following year, endorsing the company’s 510(k) application for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.


Amp Orthopedics is a subsidiary of Ivivi Health Sciences LLC, a San Francisco, Calif.-based developer of inductive electrotherapy technology. Its signature product is the Ivivi Torino II, a portable, battery-operated non-invasive device that generates a targeted low-intensity time-variant electromagnetic field. This field, according to Ivivi, accelerates the body’s natural anti-inflammatory activity and

reduces the production of a key pro-inflammatory cytokine, IL-1β. Use of the FDA-cleared Torino II can relieve pain and edema better than approved pain medications and non-steroidal anti-inflammatory drugs, executives claim.


Patients enrolled in a double-blind, placebo-controlled study several years ago used the Torino II to relieve osteoarthritis pain in their knees. Participants strapped the device to their knees twice a day for six weeks, allowing the product’s low-intensity pulsating electromagnetic frequency to target the afflicted area for 15 minutes at a time. All patients given a working Torino II (as opposed to a placebo device) experienced a 40 percent reduction in pain on their first day.


In laboratory tests, electromagnetic signals have been used to decreased calcium in cartilage cells. This reduction, experts claim, triggers a series of chemical reactions that can help reduce inflammation.


Before its use in knee osteoarthritis clinical trials, electromagnetic fields have only been used to control pain resulting from cosmetic surgery, Ivivi executives said.


Otto Bock Unveils New Knee Brace


Don Struebing may be a football coach, but his true job—his main job, really—is to protect his players.
That task hasn’t always been so easy to fulfill, particularly considering the brutal nature of the game.

But Struebing’s job recently became a bit easier, thanks to a new knee brace from Otto Bock HealthCare LP that he claims better insulates his team from injuries. “My job is to protect my players, and I am confident that the Xeleton brace is the best product on the market,” gushed Struebing, offensive coordinator for Har-Ber High School in Springdale, Ark., a 174-year-old city of 69,797 residents in the northwestern part of the Natural State. “Even under the most extreme situations we never saw the Xeleton migrate and the low profile made it easy and comfortable for my players to wear. Otto Bock’s new Xeleton brace performed better than any other brace we’ve used.”



The Xeleton brace features an anatomical shape and user-friendly design, according to the company. It off-the-shelf, hard-frame aluminum device provides customizable function for sports injuries, offers patients pre-surgical or post-surgical stabilization, or can be used to help treat chronic knee joint instabilities.


To address common knee injuries,including anterior cruciate ligament (ACL) ruptures, the Xeleton provides prophylactic and rehabilitative support after a cruciate ligament injury, rupture or surgery. The device also has anti-migration features built into its design.


Consisting of an aluminum frame and a strap system that provides custom fits to patients, the various configurations of the Xeleton brace can accommodate the ACL, the posterior cruciate ligament, or combined instabilities. The brace can be worn while standing, walking or climbing stairs, and its four-point rigid frame provides patients with stability while limiting tibial subluxation (both anterior and posterior).


Otto Bock HealthCare was created in 1958 as the American corporate arm of Otto Bock HealthCare GmbH, based in Duderstadt, Germany. The U.S. division, headquartered in Minneapolis, Minn., bills itself as the world’s largest manufacturer of prosthetic components.


Ortho-tag, University Collaborating on ‘Smart’ Implants


Ortho-tag Inc. and the University of Pittsburgh are on a mission to improve orthopedic implants. The two entities have formed a partnership to use Transcutaneous Near Field Communication (TNFC) technology in “smart” devices.


Ortho-Tag is affixed to an orthopaedic implant and scanned via radio-frequency with a probe and RFID tag developed at Pitt. A card (foreground) would be available to patients with an existing implant. Image courtesy of the University of Pittsburgh.

Researchers will use Ortho-tag’s technology in implants to obtain information about the way the devices work, according to the university. The technology keeps a record of patient information related to an implant and surgery, which eventually will be used for ongoing research.

The Ortho-tag integrates radio frequency identification (RFID) technology developed at the University of Pittsburgh (in Pennsylvania) and uses human tissue rather than air as a conduit for radio waves. The tag itself is attached to an orthopedic implant before it is sterilized and packaged or intraoperatively by a surgeon. The tag is scanned through near field transcutaneous technology with a patented touch probe to obtain real-time data about the implant and associated biosensors. The system is not yet approved by the U.S. Food and Drug Administration.


“Ortho-tags are attached—not built-in—to medical implants. This enables the tag to be applied and universally easily accepted by all orthopedic manufacturers without any change in design or manufacture of their products,” Lee Berger, M.D., a New Jersey orthopedic surgeon and tag inventor, said in published news reports. “I envision that orthopedic surgeons will offer patients the choice of having their implant provided with the Ortho-tag system.”


Berger believes that patients want more data about implants and crave the security of a potential detection system for infections or other implant-associated issues.


To collect data about the implant, surgeons must upload information about the patient, device and procedure performed to the Ortho-tag either interoperatively or postoperatively. Once implanted, biosensors interacting with the Ortho-tag would gauge the environment around the implant, such as the chemical balance and temperature of surrounding tissue, and the presence of harmful organisms.
The information would then be read by a handheld probe and displayed on a computer using software for secure data collection. The interactive data system, Berger said, includes the Ortho-tag Total Hip and Knee Registry, which has programmed templates for the surgeon to complete by using the Ortho-tag Touch Probe scanner to enter the implant and patient information into the registry postoperatively and during follow-up visits.


“The Ortho-tag implant information and registry information is programmed directly into the Ortho-tag so it is always with the patient, and this will ensure better and more accurate data collection, validation and improve outcome studies at a lower cost than anticipated for a paper- or computer-based national total joint registry,” he said.


India Planning to Revise its Drugs and Cosmetics Act


For years, companies worldwide have recognized the potential of India’s medical device market. So has the local government, though traditionally it has been slow to take advantage of that interest.


Until now.


Late last year, India’s Drug Controller General VG Somani said the country’s Health Ministry is planning to amend the 72-year-old Drugs and Cosmetics Act in order to recognize medical devices as a separate category. The move, he noted, would simplify regulation and give a fillip to the segment, valued at $2.7 billion (the fourth-largest in Asia) and expected to reach $6 billion by 2015, according to data from the United States International Trade Commission (USITC). Industry pundits expect India to surpass China in population by the middle of this century, with the number of elderly residents (those 60 and older) projected to reach nearly 200 million people by 2025. Like in other parts of the developed world, this rapid rise in elderly residents most likely will lead to an increase in spinal, bone and joint-related afflictions, which in turn, will drive the need for orthopedic devices such as joint replacements, artificial discs and bone replacement products. In the next three years, in fact, India’s orthopedic device market is estimated to reach nearly $600 million, USITC figures indicate.


Cardiac devices and blood glucose monitoring products are expected to be in demand too, as affluence among India’s upper middle-class swells to more than 40 percent of the population over the next two decades. The USITC claims the country currently has the world’s highest number of diabetics and will have the greatest incidence of cardiovascular disease by 2020, prompting the need for such equipment as pacemakers, electrocardiograph machines, diabetes test strips and insulin pumps.


To accommodate and benefit this growth, however, the Indian government must first strengthen the device industry. Separating medical devices from drugs and cosmetics is a good first step, as it will ensure easier regulation of medical products, Somani said. Authorities also are considering creating five medical device testing laboratories, three diagnostic device testing laboratories and opening a National Drug Regulatory Training Agency. “There is an urgent need [to] strengthen infrastructure and manpower in the medical devices sector,” Somani told the Business Standard of New Delhi.


There also is an urgent need to streamline the Indian healthcare system to better accommodate medical technology, as large OEMs—namely Medtronic Inc. and St. Jude Medical Inc.—establish operations there to capitalize on the device industry’s anticipated explosive growth. To streamline the healthcare system though, experts believe the Indian government must focus on solutions in three areas: cost, geography and technology.


India’s healthcare system is costly and for the most part, based largely on patient pay. Kaustav Banerjee, St. Jude county manager for India, suggested that government officials and medical device industry representatives work together to reduce healthcare costs to increase access to devices. The government has already taken steps to reduce costs by improving reimbursement rates for low-income patients and increasing awareness of private health insurance.


Improving geographic access to medical care will boost the industry as well, enabling more people to take advantage of the latest medical technologies and, subsequently, driving demand for certain products. The government can improve access fairly easily by enhancing the healthcare infrastructure in small cities and perhaps providing better transportation to those living in remote villages with unpaved roads.


The country also must better educate its residents about the types of available solutions to various diseases, Banerjee said. St. Jude Medical is helping the government with this effort, educating Indian doctors about the symptoms and potential treatment options for cardiac afflictions such as arrhythmia, heart failure, sudden cardiac arrest, heart valve repair and replacements.

ISO CERTIFICATIONS

• Five Star Manufacturing Inc., a New Bedford, Mass.-based firm that repairs, refurbishes and manufactures orthopedic instruments, has achieved ISO 13485:2003 certification.Corporate executives claim the achievement strengthens the company’s relationships and “provides new opportunities with customers requiring higher and more stringent standards.”

• Interstate Specialty Products, a Sutton, Mass.-headquartered manufacturer of high-performance custom gaskets and provider of precision custom die cutting services, has achieved ISO 13485:2003 certification. President John Savickas said the certification shows his company’s “commitment to continuous improvement, ability to meet customers’ needs and [dedication] to advancing its growth in the global marketplace.”

• ISO 13485:2003 certification has been awarded to OrthoSensor Inc., a developer of intelligent orthopedic devices that provide real-time, actionable information about implant placement and performance. The company’s platform technology integrates microelectronics, sensing technology and radio frequency telemetry into surgical instruments and implant trials. The Sunrise, Fla.-based company has developed the technology initially for unicompartmental, bicompartmental and total knee replacements but it can be used in other joints including the spine, hip and shoulder. “We are pleased that ISO has validated the quality of OrthoSensor’s management system for the design and manufacture of our intelligent orthopedic devices,” CEO Jay Pierce said.




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