A Medical Device Daily
Miracor Medical Systems (Vienna, Austria) reported that it has received the CE mark for the PICSO (Pressure-controlled Intermittent Coronary Sinus Occlusion) impulse system, designed to improve acute coronary syndrome (ACS) revascularization following primary percutaneous coronary intervention (PCI).
The CE mark allows European interventional cardiologists to use the system during coronary revascularization procedures following myocardial infarction and other types of acute coronary syndromes to intermittently increase the pressure in the coronary venous system.
“We believe that the PICSO impulse system will have substantial benefit for acute coronary syndrome patients, and the CE-mark enables Miracor to effectively pursue reimbursement and sales-and-marketing activities in Europe,“ said Jon Hoem, Miracor's CEO. Miracor will in 2011 initiate the post CE-mark RAMSES randomized clinical trial in seven European centers. The Principal Investigator is Jan Piek, MD, at the Academic Medical Center (Amsterdam, the Netherlands) who is also completing the 10-patient 'Prepare PICSO' trial.
“As we have seen in the 'Prepare PICSO' study, the Miracor technology reduces ischemia in acute coronary syndrome patients,“ said Piek. “We believe that the technology can open a completely new way to treat critically ill acute coronary syndrome patients,“ added Piek.
Nice supports LIPUS in bone fracture healing
The National Institute for Health and Clinical Excellence (NICE) has advised healthcare professionals in the UK that the use of low intensity pulsed ultrasound (LIPUS) technology represents a safe and effective treatment option to reduce the healing time in patients with bone fractures.
NICE concluded that LIPUS technology provides clear clinical benefit, particularly in patients experiencing delayed healing and non-union fractures. The recommendation was made following analysis of clinical data from more than 1,900 patients via a meta-analysis of 13 individual randomized controlled trials (RCTs), information from additional RCTs and registry data, plus specialist guidance from the British Orthopaedic Association (BOA) and British Limb Reconstruction Society (BLRS).
Smith & Nephew's (London) Exogen ultrasound bone healing system is indicated in Europe to accelerate the healing of fractures and to heal bones that have either delayed healing or stopped healing completely (non-unions). Exogen has shown to heal 86% of non-union fractures and accelerate the healing of fresh fractures up to 38% faster than normal. Since the technology was launched in 1997, it has been used successfully to heal fractures in hundreds of thousands of patients worldwide.
“Today's guidance from NICE shows that low intensity pulsed ultrasound is safe and has clear clinical benefits for patients with fractured bones, especially those with or at risk of complications. I would encourage healthcare professionals to utilize this important technology to promote faster and more reliable healing of their injuries,“ said Angus MacLean, MD, consultant orthopedic surgeon at Glasgow Royal Infirmary (Glasgow, Scotland).
Non-union fractures are defined as the point when bone healing has stopped and will not proceed without some type of intervention. Three studies conducted on non-union fractures demonstrated that use of Exogen for 20 minutes per day, with no other change in treatment, was highly successful for a wide range of bones (with the exception of skull and vertebrae and different types of fracture irrespective of the type of orthopedic fracture management).
iTech gets CE mark approval for MPR system
iTech Medical (Huntington Beach, California) a medical information technology company, reported that it has received CE mark approval for the commercial sale of its Muscle Pattern Recognition (MPR) system in Europe.
The MPR system is a non-invasive clinical assessment tool being developed to assist in the diagnosis and treatment of back and neck pain, one of the most common chronic conditions in the industrialized world. On Dec. 13, the company reported that it had received Health Canada approval to begin sales and marketing of the MPR system in Canada.
The company said that it is currently evaluating its marketing and distribution strategy options, including strategic partners.
PyroTITAN implantation performed in France
Ascension Orthopedics (Austin, Texas), a developer of PyroCarbon orthopedic implants, reported the first implantation of the PyroTITAN humeral resurfacing implant in France. The PyroTITAN was implanted in a 68-year-old patient suffering from painful primary arthritis with synovial osteochondromotosis at Imperial Park Clinic (Nice, France) – making it a surgical first in continental Europe. The patient was discharged from the hospital the next day and reported good pain relief 10 days after surgery.
Jean Marc Glasson, MD, who performed the surgery, commented, “One of the main problems with current total joint implants is that they are made of metal and polyethylene which may wear out over time. We are obligated to inform our patients that these metal and poly implants have a limited lifetime of 10-15 years. After this period, the prosthesis may loosen, the poly component may wear out, and bone loss and pain can occur. This often leads to further surgery, which may be more invasive and complicated than the first procedure. For these reasons, practitioners may be apprehensive about putting total joint replacements in younger patients. However, if the patient delays surgery, they will continue to suffer from pain. It is not an ideal situation.“
PyroCarbon has been used in orthopedic surgery for more than 30 years. It has been shown to be friendly to both cartilage and bone, making it ideal for hemi-arthroplasty and limiting the need for poly components in patients who do not have significant glenoid wear. In reference to the material, Glasson added, “PyroCarbon is a biocompatible material that is very well tolerated by the body and shows a lot of promise in the shoulder. Results with the PyroTITAN resurfacing implant at the clinical sites in Australia and the U.K. are early, but very encouraging – giving hope that with PyroCarbon, we may find lasting relief.“