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Procedure of the Month

This is the case of a 68 year-old male suffering from severe back pain for 3 months. Patient failed conservative treatment with high doses of analgesics. MRI was performed, as shown in Figure 1 below. This T2-weighted image clearly revealed evidence of acute fracture with bone marrow edema at the L1 level. Which choice do you think best describes the patient's treatment options (click on the x-ray below to take the multiple choice/guess test)?

Figure 1: Preoperative T2-weighted sagittal MRI showed evidence of bone marrow edema indicative of acute fracture at the L1 level (arrow).

Case review and x-rays courtesy of
Dr. Bassem A Georgy.
Interventional Radiologist Valley Radiology Consultants Assistant Clinical Professor University of California, San Diego

SPONSORED BY:


Procedure of the Month Sponsored by DePuy Spine, Inc.


 

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Spine News

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Scient'x Doubles 510(k) Clearance With DUO™ Dynamic Stabilization System
By Walter Eisner (posted May 9, 2008)
First there was one level...now there are two. Scient'x announced on May 6 that it had received FDA 510(k) clearance to market its new Isobar DUO™ Dynamic Stabilization System.

Facet Solutions, Inc. Completes Combination Facet Joint and Disc Replacement Study
By Elizabeth Hofheinz (posted May 8, 2008)
It’s the motion in Miami…Facet Solutions, Inc. is announcing the successful completion of a scientific evaluation for a total joint reconstruction in the lumbar spine. The study evaluated the combination of Facet Solutions’ Anatomic Facet Replacement System (AFRS™) with a semi-constrained disc replacement device in a finite element model.

Good News for Lower Extremities: Archus Completes First Human Implant of TFAS-C™ System
By Elizabeth Hofheinz (posted April 24, 2008)
They’ve come to a conclusion: Some patients can be done with fusion. The reconstructive implant aficionados at Archus Orthopedics, Inc. have announced the successful completion of the first human implant of their TFAS-C™ system, the newest addition to the company's product line for treating spinal stenosis.

DePuy Launches Spine System for Small-Stature Patients
By Walter Eisner (posted April 23, 2008)
DePuy Spine has launched a titanium and stainless steel hook, rod and screw system designed to treat complex spinal deformities in small-stature patients.

The Rising Spinal Implant Market
By Matt Menze (posted April 22, 2008)
“A rising tide lifts all boats.” With more than 30 million physician visits each year for back-related symptoms leading to a million plus spine-related surgical procedures, spine care is a $7.1 billion business. The 800-pound gorilla in this market? It’s still instrumentation and interbody fusion devices. What’s driving spinal implant growth? We use PearlDiver’s massive databases to find the answer.

DePuy Spine Launches Vertebral Body Replacement
By Walter Eisner (posted April 17, 2008)
After an initial release last July, DePuy Spine has now formally launched the CONCORDE™ Bullet Vertebral Body Replacement. CONCORDE is a new implant with a bulleted nose, which the company says facilitates easy insertion, and it has pyramidal teeth that resist anterior migration during posterior and minimally invasive spinal fusion procedures.

Orthovita Introduces VITASURE™ Absorbable Hemostat
By Elizabeth Hofheinz (posted April 17, 2008)
The spine and orthopedic biosurgery experts at Orthovita, Inc. announced that they have obtained certain rights to distribute an absorbable hemostat product developed by Medafor, Inc., a Minneapolis-based medical device company.

SpineMark Creates First Spine Research Organization in Los Angeles and Denver
By Walter Eisner (posted April 17, 2008)
SpineMark is creating the nation's first multidisciplinary, multisite Spine Research Organization (SRO) through collaboration with Los Angeles- and Denver-area physicians.

First KIMBA® Mini System Implanted
By Walter Eisner (posted April 11, 2008)
The first surgery using SIGNUS Medical's new KIMBA® Mini system was performed at the Olympia Hospital in Los Angeles by Dr. Sam Bakshian.

The Evolving Reimbursement Landscape for Spine Procedures
By Elizabeth Hofheinz (posted April 8, 2008)
CMS, AMA, 510(k)…Oi. Cindy Vandenbosch, President of Strategic Reimbursement Consulting talks here about procedure codes, coverage, and the high bar for evidence-based medicine.

Nanotechnology + Stem Cells for Spinal Cord Injury Repair
By Robin Young (posted April 7, 2008)
Northwestern University researchers have published a new paper in the April 2 issue of The Journal of Neuroscience describing a new nano-engineered gel that inhibits the formation of scar tissue at spinal cord injury sites and enables the severed spinal cord fibers to regenerate and grow.

Pioneer Surgical Receives Clearance for “No Torque” Pedicle Screw System
By Walter Eisner (posted April 7, 2008)
In 2007, Marquette, Michigan-based Pioneer Surgical acquired the global rights to a pedicle screw system called the LowTop™ from AlpineSpine, LLC.
On the 1st of April, Pioneer announced that this "no torque" locking feature pedicle screw system had received 510(k) clearance from the U.S. Food and Drug Administration.

Chan Sentenced To Canada, Probation and Light Fine
By Walter Eisner (posted April 4, 2008)
Dr. Patrick Chan, the Arkansas neurosurgeon who pled guilty to bribery in January for demanding kickbacks for using specific medical equipment, has now been sentenced by U.S. Federal Judge Susan Webber Wright.

LDR Completes Enrollment for Mobi-C® Cervical Disc
By Walter Eisner (posted March 28, 2008)
Austin, Texas-based LDR has completed enrollment for the two-level IDE study of its second-generation Mobi-C® cervical artificial disc. LDR began enrolling patients in the first concurrent one- and two-level cervical artificial disc study in April 2006, following nearly two years of clinical experience with the Mobi-C outside the U.S.

Alphatec Acquires Vertebral Body Replacement Technology
By Robin Young (posted March 24, 2008)
Alphatec announced that it has entered into a license agreement with Stout Medical whereby Stout would provide to Alphatec a worldwide license to develop and commercialize Stout's expandable interbody or vertebral body replacement technology.

New Market Study Pegs Global Cervical Artificial Disc Market at $1 Billion by 2012
By Robin Young (posted March 24, 2008)
Millennium Research Group has just issued a new market research report for the spinal non-fusion market. The report covers the U.S., Europe, and the Asia-Pacific region.

Globus Launches NIKO™ Corpectomy Spacer System
By Elizabeth Hofheinz (posted March 21, 2008)
Saving time and space…Globus Medical, Inc. has announced the introduction of its NIKO™ Corpectomy Spacer System, which, says the company, reduces the time required for surgeons to perform multilevel corpectomies by offering an unprecedented array of interoperative options.

Axial Biotech’s Spine/Genetic Convergence Reaches Milestones
By Walter Eisner (posted March 20, 2008)
Axial Biotech of Salt Lake City has met several "major" scientific milestones in the development of its genetic prognostic test for Adolescent Idiopathic Scoliosis (AIS), according to a recent company announcement.

Life Spine Gets Clearance for Lynx™ Cross Connector
By Walter Eisner (posted March 20, 2008)
Hoffman Estates, Illinois-based Life Spine has received 510(k) clearance from the U.S. Food and Drug Administration to market its Lynx™, a new cross connector system designed for use in surgical lumbar fusion procedures.

 

   

News Shorts
Complete Issue - PDF Past Issues

Scient'x Doubles 510(k) Clearance With DUO™ Dynamic Stabilization System
First there was one level...now there are two. Scient'x announced on May 6 that it had received FDA 510(k) clearance to market its new Isobar DUO™ Dynamic Stabilization System.

Alphatec Ponies Up $11 Million Settlement for ‘678 Patent
"Alphatec can now achieve some certainty." That's what Alphatec's President and CEO, Dirk Kuyper, told us at the SAS annual meeting in Miami Beach. He was referring to his company's announcement that its 2006 lawsuit with Biedermann and DePuy over the ‘678 pedicle screw patent is settled.

Abbott Spine’s Universal Clamp™ Now Available Stateside
The Universal Clamp™ spinal fixation system, developed by Abbott Spine, may now be enjoyed by Americans. The implant, which has been available in Europe for over a year, can be used to correct a wide variety of complex spinal pathologies including sagittal and coronal malalignment, as well as degenerative conditions of the thoracolumbar spine.

Facet Solutions, Inc. Completes Combination Facet Joint and Disc Replacement Study
It’s the motion in Miami…Facet Solutions, Inc. is announcing the successful completion of a scientific evaluation for a total joint reconstruction in the lumbar spine. The study evaluated the combination of Facet Solutions’ Anatomic Facet Replacement System (AFRS™) with a semi-constrained disc replacement device in a finite element model.

Biologic Bummer for Stryker in Beantown
Stryker's stock stopped trading for 16 minutes before resuming on Friday, May 2. The reason was because Stryker was about to announce that its Biotech division, in the Boston suburb of Hopkinton, had received a warning letter from the U.S. Food and Drug Administration (FDA) related to quality systems and compliance issues.

MAKO’s Robot Zaps 1st Quarter Expectations
MAKO Surgical Corp. reported 2008 first quarter revenues of $500,000. Analysts had expected revenues of only $300,000. The company markets its Tactile Guidance System™ (TGS™), an advanced robotic-arm solution, and its implants for minimally invasive orthopedic knee procedures, known as MAKOplasty®.

Shake Up at Medtronic Sofamor Danek
We were frankly surprised as were many people both inside and outside the company to hear of Pete Wehrly’s sudden departure from Medtronic Sofamor Danek day before yesterday. Mr. Wehrly, 49, was the President of Medtronic Sofamor Danek and the abruptness of his departure followed by Medtronic’s extreme caution in commenting adds additional mystery to the circumstances of Pete’s leaving.

DePuy Puts 3 Million Sq. Ft. to Work in China
DePuy products have gone into production in Suzhou, China. Tradingmarkets.com reported on April 25 that Johnson & Johnson Medical (DePuy-Suzhou) Ltd. has started operations at its first Chinese facility to produce medical equipment in the Suzhou Industrial Park in eastern China.

Smith & Nephew Endoscopy Launches FOOTPRINT PK Suture
Just try to follow in their footsteps! Smith & Nephew's Endoscopy Division has announced the launch of the FOOTPRINT PK Suture Anchor, a system used to attach rotator cuff tissue to bone in the shoulder.

Put on Your Futuristic Headgear: Immersion Medical and GMV Sign Agreement for Reality Arthroscopy Simulation System
So much for skiddishness about minimally invasive surgery…Immersion Corporation, a touch feedback technology firm, and GMV, an engineering firm, have announced that Immersion Medical, a wholly owned subsidiary of Immersion, and GMV have signed an agreement whereby Immersion Medical will market and sell GMV's insightArthroVR® virtual reality arthroscopy surgical simulator in most countries around the world.

Zimmer Revenues On Target for First Quarter. Disappoints Investors
Zimmer reported first quarter 2008 revenues (constant currency) on April 24. Total Revenues: up 6.2% to $1.06 billion. The company also announced a $1.25 billion stock repurchasing program and reaffirmed earlier guidance for the year of 6%–7% revenue growth (in constant currency).

Physician Disciplinary Actions Decline 22% Since 2004
With the current hyper-vigilant focus on surgeon and industry relationships, it begs the question: Are disciplinary actions against physicians increasing or decreasing?

Frost & Sullivan Shines Light on Raymedica
Feelin’ hot, hot, hot! Frost & Sullivan has named Raymedica, LLC, as winner of the 2008 Frost & Sullivan Hot Investment Opportunity Award.

NuVasive Revenues Break Expectations, Lukianov Waives HIPAA
The NuVasive Chairman and CEO waived all his HIPAA rights during a first quarter 2008 conference call with analysts on April 22 when asked about his own back surgery. He said he's doing very well after his two-level XLIF® procedure, thank you very much.

Good News for Lower Extremities: Archus Completes First Human Implant of TFAS-C™ System
They’ve come to a conclusion: Some patients can be done with fusion. The reconstructive implant aficionados at Archus Orthopedics, Inc. have announced the successful completion of the first human implant of their TFAS-C™ system, the newest addition to the company's product line for treating spinal stenosis.

DePuy Launches Spine System for Small-Stature Patients
DePuy Spine has launched a titanium and stainless steel hook, rod and screw system designed to treat complex spinal deformities in small-stature patients.

BoundaryMedical Inc. Launches Orthopedic Outcome Measurement Software
BoundaryMedical, Inc. may be able to streamline things. It has just introduced the new Outcome Enterprise™ Study Manager platform for measuring outcomes relating to orthopedic treatments.

People in the News

Jack Maertens Joins Theken Family of Companies as VP of Marketing

Mike McCarthy Joins Board at Facet Solutions

Patrick O’Donnell Joins Medical Capital Advisors

St. Francis Founder Joins Active Implants’ Board

Upcoming Conferences

SpineWeek
May 26 - 31, 2008 – Geneva, Switzerland

CMSA's 18th Annual Conference & Expo
June 17 - 20, 2008 – Orlando, Florida

 

   

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