Posted on | May 15, 2013 | No Comments
8 Trends for Surgical Management of Lumbar Spinal Stenosis (Beckers)
Researchers led by Hyun Bae, MD, a spine surgeon with Cedars-Sinai Medical Center in Los Angeles, examined patients who underwent surgery for lumbar spinal stenosis from 2004 to 2009 from the Nationwide Inpatient Sample, a database developed as part of the Healthcare Cost and Utilization Project, and the findings were published in Spine.
The researchers studied patients with lumbar spinal stenosis alone, with spondylolisthesis and with scoliosis. Treatment included decompression only, simple fusion and complex fusion. The trends included:
- • Annual number of patients discharged inpatient with the primary diagnosis of lumbar spinal stenosis increased from 94,011 to 102,107.
- • Rate of decompressions decreased during that time period from 58.5 percent to 49.2 percent.
- • Simple fusions for these patients increased from 21.5 percent to 31.2 percent
- • Complex fusion rates for these patients did not change — they remained at 6.7 percent.
- • Bone morphogenic protein use doubled from 2004 to 2009, from 14.5 percent to 33 percent of all fusions.
- • Interbody device use also increased in these patients from 28.5 percent to 45.1 percent.
- • According to the report, in 2009 26.2 percent of patients with lumbar spinal stenosis without instability underwent fusion procedures.
- • In 2009, 82.7 percent of patients with lumbar spinal stenosis and spondylolisthesis underwent fusion and 67.6 percent of patients with lumbar spinal stenosis and scoliosis underwent fusions.
Posted on | May 12, 2013 | No Comments
Orthopedics and Spine: How 3 Threats Can Become Opportunities (Beckers)
“The sky is not falling,” said Bill Munley, vice president of Orthopedics and Professional Services, at a session during Becker’s Hospital Review 4th Annual Meeting in Chicago on May 9.
Throughout a session, panelists including Mr. Munley, Jeff Leland, CEO of Blue Chip Surgical Center Partners and Allen Marsh, ortho/neuroscience/surgery service line director at CaroMont Health in Gastonia, N.C., reiterated that many of the perceived threats facing the industry can be seen as opportunities.
1) How bundled payment programs are opportunities. “Bundled payment programs represent opportunities for surgeons and hospitals that recognize fee for service is gone,” said Mr. Leland. As operating rooms increasingly become cost centers for hospitals, hospitals have a chance to use value-based purchasing and subcontracting to keep quality of care high while keeping costs down, said Mr. Munley.
Posted on | May 11, 2013 | No Comments
MEDSHAPE: FDA NOD FOR ECLIPSE (Orthopedics This Week)
MedShape, Inc. has announced the receipt of FDA 510(k) clearance for its Eclipse Soft Tissue Anchor, a new shape memory fixation device designed to attach a tendon, ligament or soft tissue to bone. The product is made of MedShape’s proprietary PEEK (polyether ether ketone) Altera material, and offers a non-rotational insertion method that allows for improved fixation strength.
Because it is compressed on one side, Eclipse allows more space for surgeons to accommodate a tendon alongside the implant. It also incorporates an open tip in the sheath for a suture to be fed through the implant, and its non-tapered shape provides more soft tissue compression across the bone. In addition, the Eclipse anchor offers a wider choice of sizes—it is available in diameters 4 through 9 mm, and 10 through 20 mm in length allowing for its use in a variety of soft tissue repair procedures in the shoulder, knee, hand/wrist, and foot/ankle. Like ExoShape, the Eclipse Soft Tissue anchor offers strong fixation, easy insertion and procedural versatility.
Posted on | May 11, 2013 | No Comments
Zimmer in Warsaw cuts 50 jobs (ABC 57)
A spokesperson from Zimmer in Warsaw says the company will cut the jobs of dozens workers.
The director of public relations told ABC57 the change will affect fewer than 50 people.
In a statement to ABC57:
Over the past several years, Zimmer has pursued a number of transformation initiatives that position the Company for sustained growth. These programs have enabled Zimmer to increase the productivity of our new product development programs and better meet the needs of our Customers.
As part of these ongoing efforts, the Company today implemented certain actions that resulted in employee reductions across its businesses and geographic segments. All affected employees will be supported with a range of severance and outplacement benefits.
Less than 50 full time employees were impacted by today’s changes in Warsaw.
In 2012, the company laid off nearly 100 workers.
The Warsaw Chamber of Commerce president says that initial lay off was a wake up call for the community. And it shows the challenges that they need to address.
According to Zimmer’s website, the company employs about 8,000 people around the world.
The company is considered a dominant force in orthopedics for over 80 years.
Posted on | May 7, 2013 | No Comments
SURGEON TRANSPLANTS SHIN BONE WITH MENISCUS (Orthopedics This Week)
also read… Trend #3 Orthoplasty
The Edmonton Journal (Canada) reports an uncommon surgery performed for the first time in the area. Orthopedic surgeon Nadr Jomha transplanted a shin bone, complete with the cartilage and meniscus to reconstruct the knee of a 22-year-old man who had suffered a serious workplace injury.
The patient injured his leg two years ago when a 1,000-kilogram pump jack weight tipped over on his left leg. He had a five-centimeter tear in the main blood vessel in his leg, a dislocated knee, and rips to three of the four ligaments in his knee.
Jomha initially conducted several surgeries to stabilize the leg and repair the blood vessels, after which he reconstructed the torn ligaments using donated tendons. However, he soon realized there was a more serious problem. The top of the patient’s shin bone had died and begun collapsing.
Jomha contacted a new tissue program in Calgary to see if it had any donated parts that would fit his patient. It did. Jomha had a good match. In the surgery, Jomha sawed off the dead part of the patient’s shin bone and removed it. He made the same cut on the donor bone, leaving the cartilage and meniscus attached.
Jomha transplanted all three components into the leg, securing the donor bone onto the original bone with a plate and screws. Over time, he said, the body replaces the foreign bone with its own bone in a process known as creeping substitution. Unlike live organ transplants, no anti-rejection drugs were required.
Though the patient still has months of rehabilitation ahead, the transplant operation has already made a difference in that he can bend his knee further and with far less pain than before. He hopes he can soon discard his crutches and start to put weight on the leg.
Posted on | May 6, 2013 | No Comments
DEPUY ORTHOPAEDICS, INC. RECEIVES FDA PMA SUPPLEMENT APPROVAL FOR CERAMAX® TOTAL HIP SYSTEM WITH BIOLOX® delta CERAMIC-ON-CERAMIC 36MM LARGE FEMORAL HEAD (press release)
DEPUY ORTHOPAEDICS, INC. RECEIVES FDA PMA SUPPLEMENT APPROVAL FOR CERAMAX® TOTAL HIP SYSTEM WITH BIOLOX® delta CERAMIC-ON-CERAMIC 36MM LARGE FEMORAL HEAD
New Ceramic-on-Ceramic Option Provides Additional Choice within PINNACLE® Hip Portfolio in the U.S.
DePuy Orthopaedics, Inc. has received Pre-Market (PMA) Supplement Approval from the U.S. Food and Drug Administration (FDA) for the DePuy CERAMAX® Total Hip System with BIOLOX® delta Ceramic-on-Ceramic 36MM Large Femoral Head. DePuy Synthes Joint Reconstruction is a division of DePuy Orthopaedics, Inc.
This PMA supplement approval for the 36mm size follows the initial PMA approval of the CERAMAX Hip 28mm size in 2010. Upon launch of the CERAMAX System this summer, the company’s PINNACLE® Acetabular Cup System will offer the only FDA approved ceramic-on-ceramic bearing surface with BIOLOX delta Femoral Head, a new, next generation nano composite ceramic material.
The key benefits of BIOLOX delta Ceramic Head are its very high strength and toughness. These properties are achieved as a result of the high density of the material and the very small grain size of the alumina matrix.1 Since 1974, previous versions of BIOLOX Ceramic Heads have been used in millions of implants throughout the world.2
Posted on | May 6, 2013 | No Comments
NuVasive Announces Acquisition of Manufacturing Facility (press release)
SAN DIEGO, CA–(Marketwired – May 6, 2013) – NuVasive, Inc. (NASDAQ: NUVA)
- Marks foray into full scale implant manufacturing
- Creates long term opportunity to improve operating margin
NuVasive, Inc. (NASDAQ: NUVA), a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, announced today the acquisition of ANC, LLC, a spine implant manufacturer based in Dayton, Ohio.
NuVasive has been involved with the manufacturer since it was established in May of 2010 as a manufacturing partner. The relationship expanded over the past 3 years, and ANC is currently one of NuVasive’s significant implant suppliers.
Alex Lukianov, Chairman and Chief Executive Officer, said, “We are very excited to welcome ANC’s 65 member team into the NuVasive family. Over the past three years, we have been very impressed with ANC’s progression as a quality manufacturer and their cultural fit with NuVasive. The facility will be designated NuVasive Manufacturing, LLC, and we look forward to expanding their capacity and systems as we grow together. Bringing portions of our manufacturing in house is a key element of our ongoing commitment to improve operating profitability as we grow toward $1 billion in revenue and beyond. With Speed of Innovation as a fundamental cornerstone of our success, the acquisition will reduce the time from the concept of a new idea to ultimate market introduction, enabling development and manufacturing to work seamlessly in launching our innovative solutions.”
Posted on | May 5, 2013 | No Comments
5 Recent Orthopedic Device Company Expansions & Agreements (Beckers)
- SpineCraft has recently moved its office location to Westmont, Ill., and has since been expanding its team. The company has also signed a distribution agreement with Zimmer for the APEX Spine System, which will allow the company access to key U.S., Canadian, New Zealander and Australian markets.
- NuVasive, based in San Diego, has opened an office in Tokyo, which allows the company access to the second largest spine market in the world. The company now has eight international offices.
- Amendia, based in Marietta, Ga., has announced plans to double the size of its spine manufacturing operations. The company will expand its manufacturing facility from 49,000 to 90,000 square feet.
- Biomet Microfixation has made an exclusive distribution agreement with Oxford Performance Materials for OPM’s OsteoFab Patient Specific Cranial Device. Biomet now holds exclusive global distribution rights to the cranial device and OsteoFab craniomaxillofacial implants.
- Zimmer is seeking to expand in the orthopedic markets. It currently has 75 percent exposure in the hip and knee orthopedic device markets. The company has also been investing in the emerging orthopedics markets in India and China.
Posted on | May 5, 2013 | No Comments
Emerging Markets Heat Up for Device Makers (Motley Fool)
read also… 13 Orthopedics Trends Observed by Tiger
With the medical device industry struggling for growth, leading companies have had to look elsewhere to power up stagnating sales. That’s gone beyond expanding their product lines: Some of the best names in the business have looked across the oceans for future growth, where lucrative and untapped emerging markets become tomorrow’s medical device battlefields.
British device maker Smith & Nephew (NYSE: SNN ) is the latest company to join the emerging markets push. The company announced it agreed to buy Indian trauma device maker Adler Mediequip, which — along with the buyout of a Brazilian distribution partner — totaled around $70 million. What does this mean for your investment and the medical device industry’s emerging markets momentum?
Smith & Nephew’s well-timed move
Smith & Nephew announced the news on the back of a disappointing earnings report on Thursday. The company’s sales slid less than 1%, but that fall is a trend that we’ve seen plenty of during this earnings season. Medical device companies have had a hard time finding revenue traction with pricing pressures in the industry, although orthopedics-centered firms such as Smith & Nephew have generally done better than the competition.
Posted on | May 3, 2013 | No Comments
Zimmer Acquires Knee Creations, LLC’s Business
Zimmer Expands Portfolio of Technologies Addressing the Continuum of Care for Knee Patients with Addition of Unique Subchondral Joint Preservation Treatment
Zimmer Holdings, Inc. announced today that it has acquired the business assets of West Chester, Pennsylvania-based Knee Creations, LLC. The acquisition enhances Zimmer’s product portfolio of knee treatments through the addition of Knee Creations’ Subchondroplasty® procedure. Subchondroplasty is an innovative, proprietary joint-preservation treatment that has been shown to deliver sustained relief to patients with knee pain, with or without arthritis. It is the first procedure to address an unmet clinical need between early interventions, including NSAIDs and arthroscopy, and total joint replacement.
Posted on | May 3, 2013 | 1 Comment
Medtronic Cutting 230 Jobs from Its Spinal Business (Twin City Business)
The cuts affect about 4 percent of employees in Medtronic’s spinal business; none of the layoffs impact the company’s Minnesota work force.
Medtronic, Inc., is cutting 230 jobs worldwide from its Memphis-based spinal division.
The company’s spinal division has roughly 5,600 employees, although it does not employ a work force in Minnesota, and none of the cuts will affect Twin Cities employees, according to Cindy Resman, a spokeswoman for Fridley-based Medtronic. About 60 of the cuts will occur in Memphis, she said.
Posted on | May 2, 2013 | No Comments
INDIA SURGEON RECONSTRUCTS ANKLE BONES
India has the dubious distinction of having more than 63 million people living with diabetes, according to Shobha Shukla, writing for Citizen News Service. India is second only to China in the number of people living with diabetes which, being a disease of the blood vessels, often results in destroyed hind foot bones.
While osteomyelitis in the diabetic foot can vary from 18% to 68%, the diabetic foot is also prone to Charcot’s osteoarthropathy—a severe complication of diabetes which leads to soft and brittle foot and ankle bones. Both of these conditions can result in the destruction or excision of foot bones and in amputation of the infected part. Shukla writes that an estimated 50,000 amputations occur every year in India due to diabetes-related foot problems.
Enter diabetic lower limb and foot and ankle reconstructive surgeon Professor Ajit Kumar Varma, M.D. of the Department of Endocrinology and Podiatric Surgery at the Amrita Institute of Medical Sciences (AIMS), Kochi, Kerala. This is the only center in India where a new type of reconstructive and corrective foot and ankle surgery is being performed in large numbers in high-risk diabetic foot patients.
Varma has pioneered a novel foot and ankle reconstruction surgery, using poly methyl methacrylate (PMMA) as a foot bone replacement prosthesis for severely destroyed foot and ankle bones. By employing these novel surgical techniques a large number of amputations in patients living with diabetic foot ulcers and deformed diabetic feet are being prevented. AIMS has been able to maintain a lower-limb salvage rate of 91.5%, in diabetic foot and ankle diseases.
Posted on | May 2, 2013 | No Comments
Smith & Nephew to acquire Indian trauma business (press release)
Sushrut Surgicals website http://www.sushrut.com/
Smith & Nephew plc (LSE: SN, NYSE: SNN), the global medical technology business, today announces an agreement to acquire Adler Mediequip Private Limited and with it, the brands and assets of Sushrut Surgicals Private Limited, a leader in mid-tier, orthopaedic trauma products for the India market. The transaction is expected to complete upon the satisfaction of customary conditions. The terms are not disclosed.
The acquisition will give Smith & Nephew a well-established platform to provide and develop products for the mid-tier market in India and for export. In particular, it gives Smith & Nephew an entry point to India’s fast growing trauma segment.
Olivier Bohuon, Chief Executive Officer of Smith & Nephew, commented:
“Through this important acquisition we are continuing to deliver on our Strategic Priorities to build leadership positions in the emerging markets, to supplement our organic growth through acquisitions, and to bring forward a mid-tier offering for these regions.
Posted on | May 2, 2013 | No Comments
WENZEL LAUNCHES IN SITU EXPANDABLE FUSION DEVICE (Orthopedics This Week)
Wenzel Spine, Inc. has launched its VariLift-C stand-alone zero-profile expandable cervical interbody fusion device in the U.S. The company received FDA clearance in January 2013.
The device is an interbody fusion device for stand-alone use and may be implanted without supplemental fixation. It is indicated to be implanted as a single device or bilaterally via an anterior approach.
Andy Redmond, M.D., Neurosurgeon at Precision Spine Care in Tyler, Texas, said the device simplifies ACDF (Anterior Cervical Discectomy and Fusion) procedures during cervical fusion surgery by expanding in situ once it’s properly positioned, without the need for anterior plating. “The ease and simplicity of VariLift-C make it an ideal technology for ACDF procedures, particularly in use with adjacent segment disease cases as it allows for the treatment of adjacent levels without the need to remove and replace previous constructs.”
Posted on | May 1, 2013 | 1 Comment
ISTO AND ZIMMER PART WAYS (Orthopedics This Week)
ISTO Technologies, Inc. and Zimmer Holdings, Inc. have reached a fork in the road. And they’re taking it.
On April 29, 2013, ISTO announced that the companies have called off their collaboration and will go their own ways to develop products to repair cartilage defects. ISTO is assuming full control of the DeNovo ET engineered tissue program. Zimmer will get ownership of DeNovo NT, a particulated juvenile cartilage allograft tissue implant product. ISTO is renaming DeNovo ET to RevaFlex.
We asked ISTO Chief Financial Officer Scott Gill why the companies were parting ways.
Strategic Objectives and Time Horizons
Gill said after working with Zimmer for several years on both the DeNovo ET and DeNovo NT programs, “it became apparent to both parties that it made more sense for each of us to take full control of the program that best fit the strategic objectives and time horizons for each company. ISTO believes that the patented cell-expansion technology and manufacturing scalability behind the newly named RevaFlex program will enable us to better deliver an off-the-shelf knee cartilage repair solution capable of meeting the large demand for such a product better than other cartilage programs currently available or in development.”
He added that his team believes that the RevaFlex program and the company’s NuQu program, an early intervention treatment for degenerative disc disease, represent the future of orthopedics and spine. “These innovative biologic products have the ability to regenerate and restore function and address some of the leading causes of disability in the U.S.”
Phase III Clinical Program
RevaFlex is an engineered cartilage implant intended to repair cartilage defects in the knee. ISTO will proceed independently with further development of the program through a Phase III clinical program.
As part of its cell-based orthobiologic platform, ISTO is currently involved in the development of two “unique and potentially ground-breaking” cell-based products intended to treat two of the leading causes of disability in the U.S. In addition to RevaFlex, ISTO is developing NuQu, a minimally invasive early intervention treatment for discogenic back pain. The company initiated Phase II clinical trials for NuQu in late December 2012.
Both the RevaFlex and NuQu programs address significant unmet medical needs related to chronic pain and disability resulting from cartilage wear and degeneration problems that occur in the knee and lower back, respectively. ISTO’s proprietary cell-expansion process provides the foundation for both programs. Through this process, allogeneic cells are expanded to create products capable of treating thousands of patients from a single donor, thus offering an economy of the scale and “off-the-shelf” therapeutic solution not possible with cartilage programs utilizing autologous cells.
Posted on | April 30, 2013 | No Comments
Spine Wave Announces U.S. FDA’s 510K Clearance of the StaXx® IB System, an Intervertebral Body Fusion Device (press release)
The StaXx® IB System Expands the StaXx® Product Portfolio and Offers the Advantage of an Expandable Intervertebral Body Fusion Device With Bone Graft Chambers
SHELTON, CT–(Marketwired – Apr 29, 2013) – Spine Wave, Inc. a privately held medical device company committed to the development and delivery of high-quality innovative medical devices for the treatment of spinal disorders, today announced that it has received 510(k) clearance from the United States Food and Drug Administration to market and sell the StaXx® IB System, an Intervertebral Body Fusion Device. The StaXx® IB System leverages Spine Wave’s well established ability to produce expandable PEEK spacers and now for the first time offers an expandable device with bone graft chambers. The Company will be previewing the device at the American Academy of Neurosurgeons meeting in New Orleans.
“We are pleased to be able to offer the StaXx® IB System as the latest product in our innovative and highly differentiated portfolio of technologies,” said John Pafford, Spine Wave Chief Technology Officer. “This is the first of several exciting products we expect to introduce over the next twelve months as we strive to deliver important and novel clinical solutions for spine surgeons.”
About Spine Wave
Spine Wave’s product portfolio features many highly differentiated technologies including the flagship product, the StaXx® XD Expandable Device, which has a five year proven track record for posterior surgery. The StaXx® XD family of products also includes StaXx® XDL which is intended to be implanted using a lateral surgical approach. In addition to the expandable technologies, the Sniper® Spine System has quickly developed a reputation as a leading MIS screw system and the simple yet versatile CapSure® PS3 Spine System is proving to be a high quality, traditional screw system with a recently expanded offering for complex surgery. The Company is growing rapidly and continues to recruit new sales managers and independent distributors to fuel the growth. The Company also continues to advance the NuCore® Injectable Nucleus technology in a European clinical trial designed to treat early stage DDD via a percutaneous injection. For further information on all of the Spine Wave products please visit the Company’s website at www.SpineWave.com.
Posted on | April 25, 2013 | No Comments
Guest post: Orthopedics future: the next ten years (TimesUnion Blog)
By: Thad Baker. The author works with Integris Orthopedics and Integris Children’s Hospital. Thad writes to inform the public and educate the community about important health issues.
Orthopedic specialists are fast becoming adept at juggling. Embracing the latest innovative medical devices and new biologic treatments designed to reduce recovery time and improve patient outcomes is often complicated by the reality of financial constraints and burgeoning compliance regulations. The future holds abundant promise—and significant challenge.
In the next ten years, you can expect to see finance play a large role in how orthopedic practices are structured and the services offered to patients. With the Affordable Care Act and Stark Laws demanding more transparent investing disclosures, surgeons are more cautious about forming relationships with medical device manufacturers.
Research and development relies heavily on input from surgeons; naturally manufacturers will continue to foster relationships with orthopedists. Remuneration guidelines for consulting and testing will likely undergo changes under the increased scrutiny. The trend toward physician-owned devices and referrals may reverse slightly. More physicians will find their revenue shrinking in direct relation to the number of Medicare patients seeking treatment. One way that practitioners will mitigate the declining reimbursement rates is to form symbiotic relationships for ancillary services such as rehabilitation therapy and orthotic supply.
Posted on | April 25, 2013 | No Comments
MOST INNOVATIVE VCF TREATMENTS HIGHLIGHTED (Orthopedics This Week)
Not all vertebral compression fractures (VCFs) are the same. For instance, some have different vertebral height profiles.
In a peer-reviewed article published in the April edition of Techniques in Regional Anesthesia and Pain Management (Volume 16/Number 2), Benvenue Medical, Inc.’s Kiva and Blazer systems were highlighted as being “among the most innovative experimental and commercial technologies available today,” according to an April 22, 2013 announcement by the company.
“While most studies have consistently shown percutaneous vertebroplasty and vertebral augmentation to be safe, effective, and cost efficient, they do have some limitations, and emerging percutaneous technologies for VCF treatment are being developed to overcome some of them—namely to effectively increase vertebral height, control cement delivery, conserve the native cancellous bone structure, among others,” said Sean M. Tutton, M.D., FSIR, Professor of Radiology and Surgery at the Medical College of Wisconsin in Milwaukee and lead author of the review article. “One noteworthy and most widely published of these emerging VCF technologies is the Kiva VCF Treatment System.” In the article, according to the company, Dr. Tutton also called Blazer “perhaps the most novel cavity creation device in this review.”
Posted on | April 23, 2013 | No Comments
NLT SPINE Chosen as a 2013 Red Herring Top 100 Europe (press release)
NLT chosen as Red Herring winner (Orthopedics This Week)
KFAR SABA, Israel–(BUSINESS WIRE)–NLT SPINE, a developer of less invasive spine procedures, was selected as a Red Herring Top 100 award winner. The list of winners represents Europe’s leading private companies and startups, with innovative technologies across their respective industries.
“Selecting startups that show the most potential for disruption and growth is never easy”
Red Herring’s Top 100 Europe list has become a mark of distinction for identifying promising new companies and entrepreneurs. Red Herring’s editors were among the first to recognize that companies such as Facebook, Twitter, Google, Yahoo, Skype, Salesforce.com, YouTube, and eBay would change the way we live and work.
“Selecting startups that show the most potential for disruption and growth is never easy,” said Alex Vieux, publisher and CEO of Red Herring. “We looked at hundreds and hundreds of candidates from all across the continent, and after much thought and debate, narrowed the list down to the Top 100 Winners. Each year, the competition gets tougher but we believe NLT SPINE demonstrates the vision, drive and innovation that define a Red Herring winner.”
Posted on | April 23, 2013 | No Comments
5 Minimally Invasive Spine Surgery Trends in ASCs (Beckers)
Hallett Mathews, MD, MBA, is the Executive Vice president and Chief Medical Officer of New York City-based Paradigm Spine, LLC, a non-fusion spinal implant and device technology manufacturer. Dr. Mathews is also a board-certified orthopedic spine surgeon.
Here are Dr. Mathews’ four outpatient surgery trends that will have a substantial impact on spine physicians.
1. New innovation can make performing outpatient spine surgery easier.
keep looking »
The pedicle screw for minimally invasive spine surgery, particularly fusions, has been routinely accepted for many years as the best method of fixation. However, Dr. Mathews says, pedicle screws are not necessarily a mainstay of decompression for spinal stenosis in outpatient spine surgery.”Pedicle screw fixation techniques are less invasive than older traditional methods, but there is a gap of evidence to prove they are always needed,” he says. “Some of these devices can be placed in an outpatient setting, but surgeons are challenging whether pedicle screws are the best device to do that.” Surgeons are discovering the concept of stabilization without fusion and are not necessarily performing fusion as their first choice for restabilization.
Last fall, Paradigm Spine received FDA pre-market approval for its coflex® Interlaminar Technology as a non fusion stabilization device for moderate to severe, one- or two-level lumbar stenosis with up to grade 1 spondylolisthesis in adult spine patients. The coflex procedure is designed as a less invasive approach, and does not require an inpatient stay. New devices, such as the coflex, are an example of motion preserving innovation pushing spine surgery into an outpatient setting, he says.
“Older techniques, more traditional open techniques, have not proven to be better than newer, less invasive techniques with level one evidence as noted in the coflex® PMA study ” he says. “The older technologies are being challenged and spine surgery is trending toward the outpatient setting.”
2. Patients are searching for low-cost spine care. Historically, physicians have had little involvement with reimbursements at their facilities, Dr. Mathews says. Costs were not in the purview of a practicing physician, but now surgeons must be very aware of reimbursements and payors requirements.