St. Jude Medical Inc. (NYSE:STJ) enrolled the first patient into its pan-European study of early interventions of irregular heartbeat.
St. Jude can enroll more than 3,000 patients across 200 centers in Europe, including locations in Belgium, the Czech Republic, Denmark, France, Germany, Italy, the Netherlands, Poland, Spain, Switzerland and the United Kingdom.
The St. Paul, Minn.-based medical goliath, which ranked 15th in the MassDevice Big 100 list of the world’s largest medical device companies, partnered with the European Heart Rhythm Assn. to test whether early, comprehensive and standardized intervention programs can benefit patients with atrial fibrillation, a condition where the upper chambers of the heart pulse erratically and affect the heart’s ability to get blood to the lower chambers or the rest of the body.
Intervention strategies may include antiarrythmic drug therapy, pulmonary vein isolation via catheter ablation and ECG monitoring.
Atrial fibrillation can affect the heart as soon as a few weeks after onset, and can lead to permanent damage, increased risk of stroke and stroke severity, increased hospitalizations, heart palpitations and death.
Medtronic Inc. (NYSE:MDT) landed FDA approval to conduct clinical trials of its Advisa SureScan second-iteration MRI-friendly pacemaker. The Minneapolis, Minn.-based company won FDA clearance for its first generation MRI-safe pacemaker in February.
Bridgewater, N.J.-based Valeritas Inc. landed European CE Mark approval for its V-Go fully disposable insulin delivery device. The device provides a continuous basal rate of insulin and allows on-demand dosing at the patient’s control. Valeritas won FDA clearances for the device in December 2010 and February 2011.
Sorin Group SpA (BIT:SRN) announced CE Mark approval for its Mitroflow aortic pericardial heart valve with phospholipid reduction treatment, a proprietary advanced tissue treatment intended to prevent calcification of the implanted valve.
- Entra Health wins Canadian approval for bluetooth-enabled glucose meter
Entra Health Systems announced Canadian approval for MyGlucoHealth, a bluetooth-enabled blood glucose meter. The device landed FDA clearance and European CE Mark in 2009.
- Mirador touts CE Mark for pressure monitoring device
Seattle, Wash.-based Mirador Biomedical announced that it won CE Mark approval for its Compass platform, a single-use, point-of-access, digital pressure measurement device.
- Telcare lands FDA clearance for 3G blood glucose meter
Telcare Inc. won FDA 510(k) clearance for its 3G wireless glucometer-smartphone device, which the company calls "merely a replacement of older technology for which insurers already pay."
- VeraLight announces CE Mark for diabetes screening device
Albuquerque, N.M.-based VeraLight Inc. landed CE Mark approval for its Scout non-invasive diabetes screening device, which needs no blood, does not require fasting and gives immediate results based on a forearm reading that takes about 3 minutes.
- Abbott lands PMA for renal stent system
Abbott (NYSE:ABT) won premarket approval for its Herculink Elite renal stent system, used to re-open narrowed regions of renal arteries with supply blood to the kidneys.
- Apnex wins FDA approval for sleep apnea study
Apnex Medical Inc. announced FDA approval to conduct a pivotal clinical study for obstructive sleep apnea. The St. Paul, Minn.-based company can test its hypoglossal nerve stimulation system in the U.S., Europe and Australia in support of its PMA application.
- MindFrame touts CE Mark for ischemic stroke treatment device
MindFrame Inc. announced CE Mark approval for its low profile Capture and Flow therapy devices, which are deployed through microcatheters to aid in flow restoration and clot extraction.
- Intelligent Medical Devices wins CE Mark for diagnostic test of hospital-acquired infections
Intelligent Medical Devices Inc. announced CE Mark approval for its automated diagnostic assay for various strains of the hospital-acquired infection C. difficile. The infection may develop after prolonged antibiotic use and is the most common cause of hospital-associated diarrhea.