NYU Has Discovered a Non-Invasive Method to Evaluate Osteoarthritis

Sodium MRI Gives New Insights into Detecting Osteoarthritis, NYU Researchers Find (NYU) Examining Sodium Ions for Knee OA (OTW)

Medtronic Is Worried About the states’ Role in Deciding Medical Device Coverage

Medtronic Inc. and other medical device makers worry about state control over what medical devices are covered by Medicaid as 40 million Americans are added to the healthcare rolls (MassDevice)

A Look Back at the “dark” History of Medtronic’S Infuse on the Eve of the Amplify FDA Decision

Bone-fusion protein raises questions about doctors’ financial stakes (Milwaukee Journal Sentinel)

Exactech Acquires MIS Spine Technology From Vertiflex

Exactech Acquires Minimally Invasive Spine Reconstruction Portfolio (Press Release) Exactech to Buy VertiFlex’s MIS Fusion Portfolio (HealthPointCapital)

Stryker to Pay $1.35M Penalties for Deceptive Marketing of OP-1 in Massachusetts

Stryker Settles State OP-1 Complaint (OrthopedicsThisWeek) AG Coakley Announces $1.35 Million Settlement with Stryker Biotech (Mass Attorney General)

A 20-Year Trend Analysis of Anterior Cervical Fusions

National Trends in Anterior Cervical Fusion Procedures (MedScape) 8-fold increase in procedures Highest increase in utilization was observed in those ≥65 years Average age increased from 47.2 years to 50.5 years over time Length of hospital stay decreased from 5.17 days to 2.38 days Complication rates decreased from 4.6% to 3.03% Prevalence of hypertension, diabetes [...]

Depuy Now Has 3 Separate Total Joint Product Problems

Depuy Orthopaedics recalls the ASR Acetabular – a component of their metal-on-metal system (FDA website) Depuy Orthopaedics receives an FDA Warning Letter for mis-marketing its TruMatch Personalized Solutions System and the Corail Hip System without proper clearance (Reuters)

FDA to Examine User Fees

FDA to examine user fees: User fees keep going up for medical device companies. Is FDA holding up its end of the bargain? (MassDevice)

Researchers Develop Better Connection Between Titanium Implants and Bone

Better Joint Replacements: Titanium Coating with Protein “Flower Bouquet” Nanoclusters Strengthens Implant Attachment (Georgia Tech) Georgia Tech researchers have developed an improved coating technique that could strengthen the connection between titanium joint-replacement implants and a patient’s own bone by manipulating signals the body’s own cells use to encourage growth.

Interview With Rick Randall, CEO of TranS1

Surgical innovations keep CEO in business (StarNewsOnline)

Integra LifeSciences Opens State-of-Art Training Center in Irvine

Integra LifeSciences Opens State-of-the-Art Center for Research, Education and Training in Irvine, California (Press Release) 2,800 square feet of classroom training and lab space, 4 surgical stations, c-arm fluoroscopy systems, and endoscopy towers for video imaging, and a lecture room that is hardwired for internet access and is equipped with audio/visual equipment.

Binder Biomedical Launches New PEEK Interbody Lumbar Spacer System

BINDER BIOMEDICAL, INC. Announces Official Launch of the NEWTON™ Intervertebral Body Fusion Spinal Spacer System (Press Release)

DePuy Recalls ASR Acetabular System, a Component of the Metal-on-Metal Hip System

FDA website Depuy originally planned a phase out, but now has gone to a recall because of the high revision rate.

The FDA Stops Regenexx Stem Cell Therapy for Orthopedics

FDA Hauls Regenexx Into Court This is a watershed case for stem cells applications in orthopedics. The FDA says that Regenexx is not approved and “no adequate and well-controlled studies have been done to demonstrate its safety or effectiveness for any indication.”

FDA doesn’T Like the Way Biomet Is Marketing the Signature Personalized Patient Care Knee System

FDA Warns Biomet

Done Deal – K2M Is Acquired by a Private Equity Firm

Welsh Carson Completes K2M Buyout Welsh, Carson, Anderson & Stowe to Acquire Majority Position in Spine Firm K2M (Press Release) K2M Acquired? (The Spine Blogger)

Gender Specific Knee Implants –> No Clinical Benefit

Gender Bender, Do Gender Knee Implants Provide Better Outcomes? (AAOS) A recent study in the Journal of Bone and Joint Surgery (JBJS) found that 85 women who received a gender-specific implant in one knee and a standard prosthesis in the other knee found no clinical benefits of the gender-specific knee.

SI-Bone Raises $11M to Develop Fusion of Sacroiliac Joint

SI-BONE, Inc. Closes $11.0 Million Financing Led by Skyline Ventures

Orthofix Opens New Headquarters in Lewisville TX

Orthopedics company opens new plant in Lewisville (Courier Gazette)

Medtronic Acquires Osteotech for $123M (A 1.3x Multiple on Trailing 12-Month Revenue)

Medtronic Press Release RTI Press Release Medtronic to Buy Osteotech for $123 Million (WSJ Online)

Feds Are Now Investigating JNJ, Medtronic and Zimmer for Sales Outside the US

Device makers under scrutiny in international bribery beef (MassDevice) The SEC is expanding an investigation begun in 2007 into “potential violations of the U.S.Foreign Corrupt Practices Act in connection with the sale of medical devices in an unspecified number of foreign countries,” adding Turkey, Italy and Malaysia to a list that already included Greece, Poland [...]

Kansas Spine Startup Develops 15-Minute Implant Procedure to Treat Lower Back Pain

Spinal Simplicity partners with Enterprise Center of Johnson County (Kansas City Business Journal)

Biomet to Add 278 Jobs in 2 Years at Its Headquarters in Warsaw

Biomet to add 278 jobs in Indiana (IndyStar)

Osteotech in a Public Battle Over Control

Osteotech girds for rumble with dissident investors (MassDevice) Osteotech Disputes Dissident Stockholders’ Frivolous and Redundant Initiatives (Osteotech Press Release) Unhappy Investors cite: poor performance and 28% stock loss under CEO Sam Owusa-Akyaw $4M loss in 2009 passed up on 2005 acquisition offer from MTF loss a major private-label contract with Smith & Nephew

Chinese Orthopedic Maker Raises $68.4M in Global IPO

China Kanghui Shares Rise After IPO Raises $68.4M (ABC) Chinese Device maker Trauson to IPO (HealthPointCapital) Trauson Holdings Company Limited (HKG:0325), a China-based producer of orthopaedic products, has today announced the details about its global offer (Chinese Stock Information)

OrthoPediatrics Opens New Global Headquarters in Warsaw, IN

OrthoPediatrics Building New Global HQ (VIDEO: Inside Indiana Business) Warsaw-based OrthoPediatrics is in the process of renovating an old car dealership in downtown Warsaw for its new global headquarters. CEO Nick Deeter says the company’s success has never been a product of demand, but the ability to get devices into the market quicker. It once [...]

Orthopedic Surgeon Whistleblower at Rush University Medical Center Exposes Medicare Fraud

Whistleblowers Return for a Second Bite at False Claims Case Against Rush University Medical Center (AIS Health) Orthopedic surgeon, Robert Goldberg MD, and another whistleblower has filed a new complaint against Rush University Medical Center in Chicago, alleging the facility and an affiliated group of orthopedic surgeons overbooked operating rooms, left residents in charge of [...]

Solstice Tracks Orthopedic Inventory With Autoclavable RFID Tags

Solstice Medical: Company to Watch (Orthopedics This Week) http://www.solsticemedical.com

The FDA Proposes 70 Changes to the 510(k) Process

FDA unveils proposed changes to 510(K) program (MassDevice) Medtronic, Stryker, J&J Face New U.S. Rules for Medical Device Approvals (Bloomberg) 510(k) premarket review process at FDA.gov (FDA) a new class IIb will require clinical data some previous 510(k)s will be revoked FDA will hear feedback of proposed changes until early October

TranS1 Launches the AxiiaLIF 2L+ for L4-S1 Fusions

TranS1’s Next Generation AxialLIF TranS1 launched the AxiaLIF 2L+ product line, an instrumentation and implant system for L4-S1 lumbar fusion.

Total Shoulder Replacements Now Allow Patients to Get Back to Swimming, Golf, Cycling and Fitness Training

Sports Often Possible After Shoulder Replacement (msnbc) Reuters link to article (American Journal of Sports Medicine)

February 22, 2012

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