News

FDA Approves Boston Scientific’s Express LD Iliac Stent System

March 11, 2010—Boston Scientific Corporation (Natick, MA) announced that the US Food and Drug Administration has approved its Express LD iliac premounted stent system for use in iliac arteries.

According to the company, the Express LD iliac stent is designed to be highly deliverable, and its Tandem Architecture stent design is engineered to balance strength, flexibility, and conformability. The company said that it plans to launch the product immediately in the United States. The Express LD iliac stent has also received CE Mark approval and is currently approved for use in the iliac arteries in a number of international markets, the company advised.

“Boston Scientific’s Express LD iliac stent incorporates a flexible... Read More

Rex Medical's Cleaner Rotational Thrombectomy System Receives 510(k) Clearance

March 11, 2010—Rex Medical (Conshohocken, PA) and Argon Medical Devices, Inc. (Athens, TX) announced that Rex’s Cleaner rotational thrombectomy system has received 510(k) clearance from the US Food and Drug Administration. Argon will lead all marketing and distribution efforts for Cleaner in the United States, European Union, and Canada, the companies stated.

According to the companies, the Cleaner device is indicated for mechanical declotting of occluded native vessel dialysis fistulae and synthetic dialysis access grafts. The Cleaner technology is an ergonomically designed, percutaneous, 6-F catheter-based system that augments the current options available for end-stage renal disease treatment. The device features a disposa... Read More

St. Jude Medical’s Engage Introducer Devices Approved in United States and Europe

March 11, 2010—St. Jude Medical, Inc. (St. Paul, MN) announced US Food and Drug Administration clearance and European CE Mark approval for the Engage and Engage TR introducers for use in diagnostic and interventional cardiac catheterization procedures. The Engage family of introducers incorporates features that offer more control and minimize risks both during access and throughout the procedure, the company stated.

According to St. Jude Medical, the Engage introducers are designed to provide femoral access to the vasculature, minimize trauma to the artery, and set the stage for the use of closure devices. The company's portfolio of Engage transfemoral introducers includes 22 model configurations of varying sizes to accommodate... Read More

Lumen’s FiberNet EPS Shows Success in High-Risk CAS Patients in EPIC Study

March 1, 2010—The Society for Cardiovascular Angiography and Interventions announced that the multicenter EPIC (FiberNet Embolic Protection System [EPS] in Carotid Artery Stenting [CAS] Trial) study found that the FiberNet EPS (Lumen Biomedical, Inc., Maple Grove, MN) had a 97.5% success rate when used in patients undergoing CAS. Subbarao Myla, MD, et al published the findings online ahead of print in Catheterization and Cardiovascular Interventions.

The EPIC investigators evaluated the safety and efficacy of the FiberNet EPS for embolic protection during CAS. The study was designed to demonstrate that the 30-day major adverse event rate... Read More

Next >