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 News    July 3, 2009
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First Human Receives Cardiac Stem Cells in Clinical Trial to Heal Damage Caused By Heart Attacks
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Heart Attack Patient Receives His Own Heart Stem Cells as Part of Medical Study to Determine Safety of New Technique to Repair Injured Heart Muscle


Infants Should Be Screened for Hip Trouble
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Developmental hip dysplasia is the most common congenital defect in newborns. The condition occurs when a hip joint is shallow, unstable or when the joint is dislocated.


New EPI Healthcare Study by June O'Neill Shows Uninsured 'Crisis' Wildly Overestimated
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Former CBO Director and Member of the President's Council of Economic Advisors' Authors New Report Titled "Who are the Uninsured?"


Dr. Donnica Moore Advocates that Women Follow a Preventive Dental Health Routine that Includes Crest Pro-Health Enamel Shield
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Leading women's health expert, Donnica L. Moore , MD, wants women to know that their dental health is important to their overall wellness. She recommends Crest and Oral-B Pro-Health products because they offer preventive solutions that can be easily integrated into a daily health regimen.


High Incidence of Obstructive Sleep Apnea in Suburban Dental Practices
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In a recent study published in the journal Sleep and Breathing, Dr Todd Morgan and others showed that the prevalence of obstructive sleep apnea (OSA) may be higher than expected in suburban dental practices.


 
 
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  Health Care Reform Details Emerge with 'Play or Pay' Requirements, Leaving Some Wondering about Small Business Owner Insurance
UDENT News on Friday, July 03, 2009 9:15 AM

As the health care reform details emerge, more entrepreneurs are wondering about health insurance for small groups and business insurance premiums. Now, they are getting some answers and are turning ...

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  Johnson & Johnson Completes Initial Tender Offer for Cougar Biotechnology
UDENT News on Friday, July 03, 2009 9:14 AM

Johnson & Johnson today announced that the initial offering period of its tender offer for all outstanding shares of common stock of Cougar Biotechnology, Inc.

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  Health Care Reform and Chronic Disease
UDENT News on Thursday, July 02, 2009 7:08 PM

In response to Congress' debate on health care reform, state and local leaders from Maryland joined together at the Baltimore Medical System at Saint Agnes Hospital Community Care Center to call f...

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  High Incidence of Obstructive Sleep Apnea in Suburban Dental Practices image
UDENT News on Thursday, July 02, 2009 8:56 AM

In a recent study published in the journal Sleep and Breathing, Dr Todd Morgan and others showed that the prevalence of obstructive sleep apnea (OSA) may be higher than expected in suburban dental pr...

Read More
 
  Pennsylvania Patient Safety Authority Releases June Advisory
UDENT News on Thursday, July 02, 2009 8:40 AM

wo hospitals in southeast Pennsylvania have successfully reduced or eliminated healthcare-associated infections (HAIs) for intensive care patients in their facilities and are featured in the Pen...

Read More
 
  Dr. Donnica Moore Advocates that Women Follow a Preventive Dental Health Routine that Includes Crest Pro-Health Enamel Shield
UDENT News on Wednesday, July 01, 2009 11:14 AM

Leading women's health expert, Donnica L. Moore , MD, wants women to know that their dental health is important to their overall wellness. She recommends Crest and Oral-B Pro-Health products be...

Read More
 
  New EPI Healthcare Study by June O'Neill Shows Uninsured 'Crisis' Wildly Overestimated
UDENT News on Wednesday, July 01, 2009 9:40 AM

Former CBO Director and Member of the President's Council of Economic Advisors' Authors New Report Titled "Who are the Uninsured?"

Read More
 
  Align Technology to Announce Second Quarter Fiscal 2009 Results on July 23, 2009
UDENT News on Wednesday, July 01, 2009 9:07 AM

Align Technology, Inc., the inventor of Invisalign(R), announced today that the Company will report second quarter 2009 financial results on Thursday, July 23, 2009 after the close of market.

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  Stemedica Discovers Significant Breakthrough in the Use of Stem Cells and Stem Cell Factors for the Treatment of Retinal Degeneration image
UDENT News on Wednesday, July 01, 2009 9:06 AM

Stemedica Cell Technologies, Inc., a leader in the manufacturing and development of clinical grade allogeneic adult stem cell technology, has discovered a significant breakthrough in the use of human...

Read More
 
  Dental Network of America (DNoA) Acquires DenteMax, Owned by Blue Cross Blue Shield of Michigan
UDENT News on Wednesday, July 01, 2009 9:05 AM

Dental Network of America, LLC (DNoA) announced today the completion of its acquisition of DenteMax, an independent subsidiary of Blue Cross Blue Shield of Michigan (BCBSM).

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  More than One-Third of Docs Say Risk Level Rising for Potential H1N1 Flu Pandemic
UDENT News on Wednesday, July 01, 2009 9:02 AM

new national study among 696 physicians revealed that more than one-third of physicians (37%) reported that there was "somewhat of a risk" that the H1N1 swine flu could result in a catastrophic pan...

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  LeadConfirm Professional, the first oral based lead test, makes getting the lead out easier. ''Aimed for the professional market, LeadConfirm Professi image
UDENT News on Wednesday, July 01, 2009 9:01 AM

Until now, determining a person’s lead exposure has been an invasive procedure involving painful blood tests. However, that has changed thanks to LeadConfirm Professional, a new saliva-based test t...

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Page:   of 47 
 
 

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Impliant Restarts European Clinical Activities for Patented TOPS(TM) Spine System

PRINCETON, N.J., June 26 /PRNewswire/ -- Impliant, Inc., a developer of novel spine arthroplasty alternatives to fusion surgery, today announced that it has resumed European clinical activities on its TOPS(TM) System, a Total Posterior Arthroplasty device designed to treat spinal stenosis with or without facet arthrosis and spondylolisthesis. The procedure was performed by the Lead Clinician of the London Spine Clinic, Mr. John C. Sutcliffe, MB ChB, FRCS.

Impliant had voluntarily suspended all clinical activities in September of last year following one device-related failure. After an extensive investigation conducted by a third-party expert in medical device retrievals and the Impliant Research and Development team, it was determined that device misalignment coupled with excessive shear loading caused the failure. As a result, Impliant has made a few minor design and manufacturing changes to the internal components of the TOPS(TM) device that allow it to better withstand high shear loads and misalignment while not affecting its range of motion.

"I am pleased with the changes Impliant has made to the TOPS(TM) System," said Mr. Sutcliffe. "I feel the device is now even better suited to stabilize the spinal segment after performing the wide decompression that my severely stenotic patients require. However, it should be noted that all of my patients with the original TOPS(TM) design continue to do extremely well, some of which have reached 12 months post-op."

Marcus Klarl, Vice President of European Clinical Affairs for Impliant, stated, "We are pleased to resume our TOPS(TM) clinical activities outside the United States and build upon the excellent outcomes generated to date by Mr. Sutcliffe and our other TOPS(TM) investigators."

The TOPS(TM) single and multi-level family of products have been implanted in over 80 patients in Brazil, South Africa, Belgium, Turkey, Israel, Germany and the United Kingdom. The company also recently received FDA approval to restart its TOPS(TM) IDE clinical study in the United States.

Impliant is applying cutting-edge materials and crossbar biomechanical techniques to develop a new class of spine arthroplasty devices that target over 40% of the patients worldwide who undergo fusion surgery and could benefit from a Total Posterior Arthroplasty solution.

Impliant's TOPS(TM) System, a mobile posterior device, is designed to stabilize but not fuse the L3-4 or L4-5 vertebral level to alleviate pain stemming from spinal stenosis with or without degenerative facet arthrosis and spondylolisthesis. Following a laminectomy and medial facetectomy, the device is affixed to the spine via four pedicle screws using a standard posterior surgical approach. Impliant believes that the TOPS(TM) System could benefit over 500,000 patients worldwide undergoing spinal fusion surgery each year. Impliant obtained CE Mark approval for the TOPS(TM) System on June 1, 2006.

Impliant, Inc. is a privately held company engaged in the development of novel spine arthroplasty solutions for some of the most prevalent pathologies of the spine. The company is currently developing the TOPS(TM) System, which has the longest clinical history in the Total Posterior Arthroplasty market segment, dating to January 2005. Impliant is also developing several next- generation and multi-level technologies to further increase its addressable market. Impliant is headquartered in Princeton, NJ with research facilities located in Ramat Poleg, Israel. Shareholders include Elron Electronic Industries Ltd. (Nasdaq, TASE: ELRN). For more information about Impliant, please visit http://www.impliant.com.


Posted on Thursday, June 26, 2008 (Archive on Thursday, July 24, 2008)
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