A Medical Device Daily
St. Jude Medical (St. Paul, Minnesota) reported receiving CE-mark approval for its AnalyST Accel and Current Accel implantable cardioverter defibrillators (ICDs), which automatically adjust therapy to changing patient needs for increased safety and accelerated follow-up.
The St. Jude Medical Accel family of ICD devices can be programmed to automatically monitor and adjust the level of electrical energy needed for stimulating the patient's heart, which helps to ensure that adequate therapy is consistently administered while conserving battery life.
The company said the devices do this by measuring the heart's reaction to electrical stimulation from the device and confirming that the heart is responding to the stimulation.
St. Jude said this AutoCapture Pacing System feature provides the dual benefit of added safety for the patient and added efficiency for physicians, as vital threshold tests are performed automatically and results are available to the physician for review on demand during follow-up via a simple device interrogation. In the Accel family of ICDs, automatic threshold management is available on all leads for the first time.
To better assist physicians in accurately diagnosing and managing patients with fast rates in the heart's upper chambers, the devices also include a new AT/AF Alert feature designed to notify physicians when a rapid atrial rate (atrial tachycardia/atrial fibrillation) exceeds a programmed value or occurs over an extended time period.
The devices can be programmed to notify the patient through a unique vibratory alert that the company said has been proven more effective than audible alerts.
The Accel ICDs also have the ability to inform the patient's clinic through the St. Jude Medical Merlin@home transmitter and Merlin.net Patient Care Network, allowing better management of patients' arrhythmias with appropriate medication or ablation.
"This family of devices enables me to streamline patient follow-up, allowing me to better manage therapy," said Johannes Sperzel, MD, of the Kerckhoff-Klinik (Bad Nauheim, Germany). "The fact that these tests are performed and thresholds are adjusted automatically means that I can quickly assess the results and then focus on other matters that concern the patient."
The AnalyST Accel ICD includes the company's ST Monitoring diagnostic algorithm, which continuously monitors specific changes in the heart's electrical system. Small changes in the ST segment are continuously recorded and plotted; the information can then be retrieved by the physician via the Merlin Patient Care System during in-office follow-up.
Alerts can also be configured so information about ST segment changes is sent directly to the physician through DirectAlerts notification, available with the Merlin.net PCN and the Merlin@home patient transmitter.
St. Jude said that because many cardiac episodes are transient in nature, the continuous ST Monitoring capability available in the AnalyST Accel ICD gives physicians more comprehensive information over time compared to the standard EKG.
CE mark for Intrinsic's Barricaid
Intrinsic Therapeutics (Woburn, Massachusetts) reported that it has received a CE mark for its Barricaid anular prosthesis for use in reconstructing soft tissues of the spine, giving it approval to distribute the Barricaid throughout the European Union and in other countries that recognize the CE mark.
"This event reflects, in part, on the very positive clinical results in our current, prospective clinical study of the Barricaid anular prosthesis," said Barry Sands, vice president regulatory, clinical and quality affairs.
The Barricaid is a partial disc prosthesis that enables surgeons to directly reconstruct the anulus of the intervertebral disc in patients with lumbar disc herniations and sciatica as part of a standard, minimal access discectomy procedure. More than 500,000 discectomies are performed worldwide each year.
"This approval gives Intrinsic the opportunity to offer surgeons, patients, and payers the potential for a truly better outcome in the treatment of lumbar disc herniation, the most common degenerative condition of the spine," said President/CEO Greg Lambrecht. "The Barricaid and its approval in the European Union is the culmination of years of extensive pre-clinical and clinical development to address this fundamental, unmet need in spine surgery. Surgeons have tried many different techniques over the years to repair the anulus including sutures, glues, and clips with very limited success."
The Barricaid offers a new surgical strategy by reconstructing the anulus and anchoring it to the vertebral body for a more secure solution. Intrinsic and the surgeons we serve are very excited by the positive results from the initial clinical study of the Barricaid that helped us reach this important milestone."
Intrinsic Therapeutics is focused on products to treat soft-tissue injuries of the spine. Its Barricaid anular reconstructive products are used during discectomy to definitively close defects in the posterior annulus and reduce the risk of recurrent herniation while maintaining disc height and biomechanics.
German, UK distributors for Athera
Athera Biotechnologies (Stockholm, Sweden), an atherosclerosis R&D company developing products for treatment and prevention of cardiovascular disease (CVD), said it has signed distributor agreements with Asbach Medical Products in Germany and Oxford Biosystems in the UK.
CEO Carina Schmidt said, "These agreements ... will allow us to reach a large number of customers in Germany and UK and will support further development of the broader clinical utility of our new CVD biomarker."
The product, CVDefine, was introduced last year and provides an easy-to-use, CE-marked ELISA kit for quantitative analysis of anti-PC in human blood.
High levels of IgM antibodies against phosphorylcholine (anti-PC) has been shown to predict less atherosclerosis development in hypertensive patients after a five-year follow up. In 2008, data was presented indicating that low anti-PC levels predict an increased risk of CVD.
Athera, which is part of the Karolinska Institute development portfolio, has two biopharmaceutical product candidates aimed at treating patients with acute heart conditions and a biomarker linked to the therapeutic approach.