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Recent Press:

TOPS™ System Launches in Germany
Motion Preserving Spine Device Eliminates Need for Fusion in Patients with Severe Lumbar Spine Stenosis
Press Release Source: Premia Spine Ltd.

RAMAT POLEG, Israel, Oct. 23, 2012 /PRNewswire/ -- Premia Spine, Ltd. announced today that the company has commercially launched the TOPS™ System and its adjunct Versalink™ Fixation System in Germany.

"We are excited about the opportunity to provide German patients with a clinically-proven, superior solution to lumbar spinal fusion," stated Ron Sacher, CEO of Premia Spine. "The TOPS™ System has demonstrated its immediate and sustained benefit for patients suffering from severe spinal stenosis and spondylolisthesis."

First cases in Germany were performed by Dr. Thomas Bierstedt, a neurosurgeon with the Orthopädisch-Neurochirurgisches Zentrum (ONZ), which serves the state of North Rhine-Westphalia.  The ONZ sees patients from Köln, Düsseldorf, Dortmund, Essen, Duisburg, Bochum, Recklinghausen, and Hattingen as well as a high number of international patients from North and South America and the Middle East.  Dr. Bierstedt is a leading spine surgeon with strong command of the latest minimally invasive, posterior arthroplasty and artificial disc technologies.

“I am very pleased with what I have seen so far with my first four patients,” explains Dr. Bierstedt.  “Patients are very mobile and free from the pain of spinal stenosis and spondylolithesis.” 

Traditional spine surgery for lumbar stenosis involves removing tissue elements pressing on the nerve roots and stabilizing the spine with rigid metal rods. There is usually a long convalescence after such procedures.

The TOPS™ System is a dynamic spinal implant designed to replace the extracted skeletal structures and stabilize the spine without permanently locking the adjacent vertebrae.  Instead, clinicians allow the vertebrae to continue moving normally with the assistance of the TOPS™ implant. The TOPS™ System allows full motion at the operative level, while prohibiting excessive twists and turns.  It recreates the physiologic motion in flexion, extension, lateral bending, axial rotation and translation.  No other device performs this range of function.   

As no fusion is taking place in the lower back, there are no restrictions placed on patients and their activity after the TOPS™ System surgery.  Premia Spine’s TOPS System has been demonstrated to provide better outcomes than lumbar spinal fusion surgery in clinical studies conducted around the globe since 2005. 


July 27, 2012 – German Spine Specialists visit the states to discuss possibilities with U.S. and Canadian patients about Artificial Disk Replacement Surgery with the M6.

M6 adr surgery

 

July 8, 2012 – German Spine Specialists is not and in no way a representative for Stenum Hospital and all of the bad press and unsuccessful surgeries related to Stenum Hospital.

Seems reps from Stenum, Sue Hart in particular, have taken it upon themselves to do as much bad press against German Spine Specialists as possible. One must ask why do they see us as such a threat? Answers are, Stenum Hospitial has filed insolvency (bankruptcy) and is now attempting to get patients by bad mouthing other organizations and pressuring new patients into rushed procedures.

Facts are facts... The German Spine Specialists team is designed to HELP people, help people with spine pain due to herniations and various degenerative disk problems achieve a level of success in relief of their pain. We have searched and searched to find a Dr. in Germany we could truly stand behind as the team at Stenum Hospital was not what we wanted to be related to and for good reason.

Unlike our "competition" we will not go into more bad mouthing, lets just say, we have more integrity than that. And we do believe the good guy wins.

Our doctor is specific to the number of patients he will operate on in one day. He does this so each patient gets his undivided attention to detail. He also does this because spine surgery and artificial disk replacement (M6 ADR) should not be treated like an assembly line. Each patients anatomy can vary, and definitely the issues they are experiencing may vary. Each patient that German Spine Specialists helps is on an individual case basis. Our team knows that others need to know there are better solutions to disk replacement and that without this knowledge these people will continue to suffer needlessly.

Our team is comprised of past M6 ADR patients that know how great the M6 ADR is and what it can due to successfully give back one's life. This is important for the public to know.

German Spine Specialists is a team dedicated to helping the world achieve a life without debilitating spine pain.

 

 

March 31, 2012, – German Spine Specialists now exclusively selects German Spine Doctor and Neurosurgeon Dr. Bierstedt as it's surgeon for Artificial Disk Replacement. Leading the world in diversity of artificial disk replacements and specializing in the proper precision and care with each patient. German Spine Specialists is elated to now have what we consider the best spine surgeon in the world on our team.

No longer do you or anyone you know have to continue to suffer. We are now able to provide the latest in medical advancements to the public.

Germany is the leader in medical technology. Laying groundwork for the world to follow, you are now able to recieve the best treatment with that technoogy.

 

 

March 14, 2012, – German Spine Specialists is now taking spinal surgical technology to new heights. Due to advancements in surgical proceedures in Germany and the ability to provide patients with the latest technology prior to other countries, due to FDA regulations, German Spine Specialists are now able to connect the world to the best in surgical treatment for stenosis, herniated disks, degenerated disks and ailments of the back that have plagued patients for years.

No longer do you or anyone you know have to continue to suffer. We are now able to provide the latest in medical advancements to the public.

Germany is the leader in medical technology. Laying groundwork for the world to follow, you are now able to receive the best treatment with that technology.

 

 

December 13, 2011 Press Release:
Spinal Kinetics Wins in Synthes Patent Suit
Synthes Patent 7,429,270 is Found Invalid

DECEMBER 13, 2011, SUNNYVALE, CA. – Spinal Kinetics, the designer and manufacturer of the innovative M6® Artificial Disc, today announced that a jury in the United States District Court, Northern District of California, has found that the M6 does not infringe on Synthes' U.S. Patent No. 7,429,270. The jury found the Synthes '270 patent invalid.

The M6-C cervical and M6-L lumbar artificial discs help patients suffering from degenerative disc disease of the spine; a common cause of chronic and severe back and neck pain. The M6 technology provides an alternative to spinal fusion and is designed to preserve motion and reduce the chances of subsequent degeneration of adjacent discs. Introduced internationally in 2006, M6 has quickly become a market leader in Europe and is available in over 17 countries worldwide. With over 13,500 implants to date, the M6 continues to generate enthusiasm among both patients and surgeons searching for a more physiologic disc replacement technology.

"We are very pleased with the jury's verdict in this case," said Tom Afzal, Spinal Kinetics' President and CEO. "The interest in the M6 disc is accelerating around the world, and the positive verdict allows us to focus our resources and efforts on making the M6 available to more patients in more countries, including future clinical trials in the U.S."

The M6 is the only artificial disc that replicates the anatomic structure and biomechanics of a natural disc by incorporating both an artificial nucleus and annulus. In the U.S., Spinal Kinetics has successfully completed an FDA IDE Pilot Study of the M6-C in patients with both single and two level disease, and has received approval from the FDA to initiate an IDE Pivotal Study.

About Degenerative Disc Disease
Between each vertebra throughout the spine is an intervertebral disc; a shock-absorbing pillow that helps maintain proper spacing, stability, and motion within the spine. Each disc has a fibrous outer band called the annulus fibrosis that encases a central, gel-like substance called the nucleus pulposus. The nucleus and annulus work together to absorb shock, help stabilize the spine, and provide a controlled range of motion between each vertebra. Degenerative disc disease is a condition caused by the breakdown of the intervertebral discs. Often brought on by age, the spine begins to show signs of wear and tear as the discs dry out and shrink. These age-related changes can put pressure on the spinal cord and nerves and may cause back pain and other spinal conditions such as spinal stenosis or a herniated disc.

About Spinal Kinetics
Founded in 2003, Spinal Kinetics is a privately held medical device company focused on partnering with spine surgeons to develop innovative and practical motion preservation systems for treating degenerative diseases of the spine. The M6-C cervical and M6-L lumbar artificial discs have rapidly established themselves among the leading artificial discs available due to their unique biomechanical properties that mimic natural discs. The company is located in Sunnyvale, California.

 

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