 |
 |
|
 |
 |
|
 |
||
|
|||||||
|
|||||||
|
|||||||
 |
|||
 FOR IMMEDIATE RELEASE ISELIN, N.J.,
July 23, 2002 - The U.S. Food and Drug Administration (FDA) has
granted approval of the Pre-Market Approval Application (PMA) to Siemens
Medical Solutions for SONOCUR® Basic, a new low-energy extracorporeal
shock wave therapy system for use in the treatment of patients with
lateral epicondylitis, a condition commonly referred to as tennis elbow.
The United States multi-center clinical trial, which began in 2000 and included the enrollment of 114 patients at three orthopedic clinics in Virginia, North Carolina, and Georgia, focused on the treatment of patients with chronic tennis elbow, a common tendon irritation (tendonitis) that is often caused by repetitive motion of the hand and forearm. During a treatment with the SONOCUR Basic system, the articulating head of the device is placed onto the area where the patient experiences pain and fine adjustments are made to the area of therapeutic focus. The device administers a preset number of pulses, or shock waves, at a low energy level, allowing for anesthesia-free treatment. “Initially I had been skeptical of the treatment, but my experience throughout the clinical trial has led me to be thoroughly convinced that the SONOCUR Basic device can decrease pain, as well as offer a significant increase in functional outcome for the patient,” said David Covall, an orthopedic surgeon and partner in the Peachtree Orthopedic Clinic in Atlanta, Georgia, who served as a principal investigator for the clinical trial. “Based on the outcome of the trial, it’s clear that the SONOCUR Basic treatment works well.” The U.S. study was randomized and double-blind, meaning that neither the patient nor evaluator knew if the treatments given to the patient were real or placebo. Approximately half of the patients participating in the study received the active SONOCUR Basic treatment while the others received a placebo treatment. Previous to their participation in the study, all of the patients had been non-responsive to at least two of three conventional therapies, including physical therapy, anti-inflammatory medications, and steroid injections, and some were facing the possibility of surgery. At 12 weeks into the clinical trial, the investigators found that a statistically significant difference in pain reduction was seen among those in the active treatment group, with 64 percent of those patients treated according to the protocols showing at least a 50 percent reduction in pain as measured during provocation tests. According to Covall, the clinical trial has shown that treatment with the SONOCUR Basic device is a non-invasive alternative to surgery for patients who have failed to respond to conventional therapies. “We found that
these treatments resulted in satisfactory outcomes in most patients,
while offering no significant (or serious) side effects due to
treatment,” said Dr. Covall. “SONOCUR Basic could prove to be a major
breakthrough-one that we haven’t seen in orthopedics for several
decades. This could revolutionize the treatment of pain associated with
tendonopathies.” “There already is
tremendous excitement about this product, based on the clinical trials
that have just finished in the United States, as well as ongoing
research in Canada and Europe,” said Myers. “We believe SONOCUR Basic is
a significant addition to the treatment options available to patients
and orthopedic physicians.” Employing approximately 30,000 people worldwide, the company reported sales of 7.2 billion EUR, orders of 8.4 billion EUR and EBITA of 808 million EUR in fiscal 2001 (September 30). More information can be obtained by visiting us on the Web at www.siemensmedical.com. Siemens AG, headquartered in Munich, is a leading global electronics and engineering company. It employs some 450,000 in 193 countries, and reported worldwide sales of more than $74 billion in fiscal 2001 (10/1/00 - 9/30/01). The United States is Siemens’ largest market, with nearly 80,000 employees and sales of $18.9 billion for fiscal 2001. For more information about Siemens in the U.S., visit www.usa.siemens.com. Sonorex, is a privately held company with United States headquarters in Fayetteville, North Carolina and Canadian business offices in Vancouver, British Columbia. The mission of the company is to provide high quality outpatient, office-based treatment of properly selected patients who have orthopedic conditions amenable to treatment with variable energy shock waves. For more information visit http://www.sonorex.ca or contact .
FOR
IMMEDIATE RELEASE ISELIN, N.J., July 23, 2002 - David Covall, an orthopedic surgeon and partner in the Peachtree Orthopedic Clinic in Atlanta, Georgia, served as a principal investigator for the clinical trial. “Initially I had been skeptical of the treatment, but my experience throughout the clinical trial has led me to be thoroughly convinced that the SONOCUR Basic device can decrease pain, as well as offer a dramatic increase in functional outcome for the patient.” “The patients involved in the clinical trial were facing the worst-case scenario. At least two other types of treatment-whether anti-inflammatory medications, steroid injections or physical therapy-had already failed for these patients and some were facing the possibility of surgery.” “If the patients didn’t improve by at least 50 percent in the first three months of the trial, they had the option of crossing over into the other treatment group, whether placebo or active. Patients who didn’t improve were most often in the placebo group. “Some patients did make the change into the active group, which allowed us as evaluators to discuss their treatment with them. Many of those patients came back to say that they were amazed at how much they had improved thanks to the SONOCUR Basic treatment.” “Based on the
outcome of the trial, it’s clear that the SONOCUR Basic treatment works,
and that it works well.” “The advantages of SONOCUR Basic are that it is office-based, requires no anesthesia, has no significant side effects, and is non-invasive. This means that the treatment will be more accessible to the patient and more cost effective. It also adds up to a significant advantage for SONOCUR Basic over other shock wave therapy devices that are currently available.” “This treatment
can make a functional difference in a patient’s life, in addition to a
reduction in pain. Many patients in this study experienced a tremendous
increase in functional ability - this means there was an improvement in
their performance of the activities of daily living. That’s what we look
for as physicians - patient satisfaction.” “We observed that these treatments made a positive difference in patients’ lives with respect to improvements in functionality, while having no significant side effects.” “This is a non-invasive treatment option that is now available prior to resorting to surgery and taking on the risks associated with an invasive procedure.” “This type of
treatment - shock wave therapy - has been around for a long time in the
form of lithotripsy and has proven to be very safe.” “SONOCUR Basic should prove to be a major breakthrough in treating painful musculoskeletal conditions. I believe that this form of non-surgical treatment could revolutionize the treatment of pain associated with tendonitis.” “We haven’t had anything really new in non-operative care in a long time. The demand for this treatment, both from the physician and the consumer, should come quickly. I believe this treatment will be widely used in a short period of time.”
FOR
IMMEDIATE RELEASE ISELIN, N.J., July 23, 2002 - Vancouver, British Columbia, native Mat Chambers has been playing tennis competitively since he was 11 years of age, participating in nearly every junior national championship tournament in Canada until his eighteenth birthday. When he left home to continue his education, he continued playing tennis at Claremont McKenna College (Claremont, Calif.), and also was enjoying some success in semi-professional tournaments throughout southern California. But all those years of playing tennis, with its repetitive motion and constant pounding, had taken their toll on the 20-something athlete. Chambers found himself battling a chronic case of lateral epicondylitis, a condition commonly referred to as tennis elbow. Physical rehabilitation and other treatments weren’t working, and he had to take a break from making his power serves. He even missed out on an opportunity to play in a European Satellite Circuit tournament with a group of college tennis players from California. “I could hardly play because of the pain,” said Chambers, who is now 23 and studying law at the University of California Hastings College of the Law (San Francisco, Calif.). “I was thinking of forgetting it.” It was then that he heard about the Vancouver, B.C. Sonorex Therapy Centre that was offering treatment with a SONOCUR® Basic extracorporeal shock wave therapy system from Siemens Medical Solutions, which has been approved for use in Europe since 1996 and in Canada since 1997. Following an exhaustive clinical trial, the device was recently approved by the Food and Drug Administration (FDA) for use in the United States for the treatment of tennis elbow. In January 2001, Chambers paid a visit to the Vancouver Sonorex Therapy Centre. Following a consultation, he underwent two treatments with the SONOCUR Basic device. “My expectations were very high - I was really hoping the treatment would go well and I would have the opportunity to play tennis again,” said Chambers. During his treatment with the SONOCUR Basic system, the articulating head of the device was placed onto the area where Chambers experienced pain. The device administered a preset number of pulses, or shock waves, at a low energy level during the anesthesia-free treatment. “I’ve done a lot of rehabilitation in my back and arm, and I have to say that SONOCUR is fast, easy and nearly painless in comparison,” said Chambers. Following treatment, Chambers was amazed to find himself returning to the tennis court, with a noticeable reduction in his pain. “When you’ve gone
through all the other options and realize how ineffective many other
treatments are, you can’t help but be amazed at how well this treatment
works,” he said. “It was unbelievable. It made a significant difference,
so that I was not only able play in tournaments, I was able to win
again.” “In Canada, SONOCUR Basic continues to have a dramatic impact on treatment of such conditions as tennis elbow, which have been difficult to treat in the past because patients often don’t respond favorably to other available methods like surgery,” said Day. “SONOCUR Basic is a non-invasive, outpatient treatment that requires little recovery time for the patient, and is very cost effective. In fact, because the treatment is so cost effective and successful at relieving pain, the Workers' Compensation Board of British Columbia is referring patients with lateral epicondylitis to the Vancouver Sonorex Therapy Centre prior to approving more drastic treatments such as surgery.” Day reports that
many elite athletes from the United States have come to Canada for
treatment, including professional baseball, hockey, golf and basketball
players. The athletes are attracted by the speedy results and short
recovery time. Siemens Medical Solutions of Siemens AG (NYSE: SI) with headquarters in Iselin, NJ and Erlangen, Germany, is one of the largest suppliers to the healthcare industry in the world. The company is renowned for its innovative products, including imaging systems for diagnosis, therapy equipment for treatment, hearing instruments, and critical care and life support systems, as well as a wide array of information technology and data management solutions that optimize workflow and increase efficiency in hospitals, clinics and doctors' offices. The company is known as the premiere Application Service Provider processing more than 116 million transactions daily and managing more than 67 terabytes of data - twice the information volume of the Library of Congress. Employing approximately 30,000 people worldwide, the company reported sales of 7.2 billion EUR, orders of 8.4 billion EUR and EBITA of 808 million EUR in fiscal 2001 (September 30). More information can be obtained by visiting us on the Web at www.siemensmedical.com. Siemens AG, headquartered in Munich, is a leading global electronics and engineering company. It employs some 450,000 in 193 countries, and reported worldwide sales of more than $74 billion in fiscal 2001 (10/1/00 - 9/30/01). The United States is Siemens’ largest market, with nearly 80,000 employees and sales of $18.9 billion for fiscal 2001. For more information about Siemens in the U.S., visit www.usa.siemens.com. Sonorex, is a privately held company with United States headquarters in Fayetteville, North Carolina and Canadian business offices in Vancouver, British Columbia. The mission of the company is to provide high quality outpatient, office-based treatment of properly selected patients who have orthopedic conditions amenable to treatment with variable energy shock waves. For more information visit http://www.sonorex.ca or contact .
FOR
IMMEDIATE RELEASE ISELIN,
N.J., June 7, 2002 - Siemens Medical Solutions has received an
approvable letter from the Center for Devices and Radiological Health of
the U.S. Food and Drug Administration (FDA) for the SONOCUR® Basic, a
new extracorporeal shock wave therapy system*. This letter signals that
the FDA has completed its main, in-depth scientific review of the
company’s Pre-Market Approval (PMA) application and the clinical trial
data.
FOR IMMEDIATE RELEASE Promising results from clinical tests prompt application for FDA's Pre-Market Approval ISELIN, N.J., August 13, 2001 - Following the delivery of promising results from ongoing clinical testing, Siemens Medical Systems, Inc., the U.S. affiliate of Siemens Medical Solutions, has taken the next step toward securing
U.S. Food and Drug Administration (FDA) approval for SONOCUR®, a new extracorporeal shock wave therapy system*. SONOCUR is being tested for use in the treatment of patients with lateral epicondylitis, a condition commonly referred to as tennis elbow. "We of course are thrilled at the continued success of the clinical testing for SONOCUR," said Anne Marie Keevins, division manager of Siemens Medical Systems. "We eagerly await the FDA's approval of our SONOCUR application." The United States multi-center clinical trial, which began in 2000 and included the enrollment of 114 patients at three study sites, has focused on the treatment of patients with chronic tennis elbow, a common tendon irritation that is often caused by repetitive motion of the hand and forearm. The study is being conducted at Commonwealth Orthopedics and Rehabilitation in Arlington, Virginia; Miller Orthopedic Clinic in Charlotte, North Carolina; and Peachtree Orthopedic Clinic in Atlanta, Georgia. This U.S. study is a randomized, double-blind (patient, evaluator), placebo-controlled study with approximately half the patients participating in the study receiving the active Sonocur treatment and the remaining patients receiving a placebo treatment. "The clinical trial results show a significant difference in favor of the active treatment group in pain reduction, improvement in upper extremity function, and the patient's overall impression compared with the placebo group, with few reported side effects," reports Cathy Anne Pinto, Clinical Affairs Manager of Siemens Medical Systems, Inc. "The data are very promising and we are hopeful that FDA will agree that these data support the safety and efficacy of our new therapy system." Also anxiously awaiting FDA-approval for SONOCUR is Dan Myers, M.D., president of Sonorex, the company that has been chosen by Siemens as the exclusive distributor of SONOCUR for the non-hospital market in the United States. Sonorex currently operates SONOCUR systems at therapy centers across Canada, including Vancouver, British Columbia; Calgary and Edmonton, Alberta; and Toronto and Ottawa, Ontario. "A lot of excitement already has been generated in the field of orthopedics about this product," said Myers. "We're looking forward to the time when we can actively market SONOCUR in the United States." In Europe and Canada, where SONOCUR has been approved for use since 1996 and 1997 respectively, the system has been marketed as a medical device used to treat and relieve the pain associated with tennis elbow, as well as other soft tissue conditions of the musculoskeletal system. Siemens Medical Solutions Sonorex
FOR IMMEDIATE RELEASE
In the United States, clinical evaluation of the Sonocur as a pain therapy system has been underway since 1999 and has focused on the treatment of patients with lateral epicondylitis, a disease commonly known as chronic tennis elbow. Tennis elbow is a common tendon irritation, which is often caused by repetitive motion of the hand and forearm. "We are pleased to see that continued testing of the Sonocur has been approved in the US since preliminary data have suggested that the Sonocur may be a viable alternative for patients who are non?responsive to other conventional therapies. Currently, these patients must consider surgery or must limit their daily activities (some as routine as lifting a gallon of milk from the refrigerator) to avoid the pain and discomfort associated with this condition. Therefore, if we can clinically prove that the Sonocur is an effective pain therapy system, this will be a significant step toward improving the patient's overall quality of life," Gunther vom Dorp, product manager for extracorporeal shockwave therapy, Special Products. With FDA's conditional approval, Siemens plans to continue clinical testing of the Sonocur system at the following four study sites:
Siemens Medical Systems. Inc. Iselin, NJ, provides solutions across a broad range of U.S. clinical environments including cardiology, neurology, oncology and women's health. In addition to developing and manufacturing medical device equipment, the company provides consulting services and information technology solutions through its Managed Healthcare Services division. Reporting annual sales of approximately $1.8 billion and employing nearly 4,500 people in the United States, it is the U.S. affiliate of the Medical Engineering Group of Siemens AG. ONLY IN CANADA, EH?Atlanta Hawks swingman Jim Jackson was raving about the "shock-wave" treatment he got here to help his tendinitis, and predicts others will beat a path to Toronto for the procedure, which isn't yet approved in the U.S.
"It was well worth taking the time away (two games, five days)," Jackson said. "I was moving with a lot more freedom. My timing wasn't what it should be. I expected that, but the pain wasn't there nearly as much." Jackson was treated at a facility at Yonge and Eglinton called Athlete's Care. The device, a low-energy shock-wave machine, is a cousin of ultrasound, and is said to encourage new tissue growth. |
|||