Express LD Iliac Stent System
Boston Scientific Corporation (Natick, MA) recently announced that the US Food and Drug Administration (FDA) has approved its Express LD iliac premounted stent system for use in iliac arteries. The Express LD iliac stent features two advanced technologies that are designed to work in tandem to meet iliac stenting needs. According to the company, the unique design of the Express LD iliac stent is intended to provide outstanding flexibility, excellent conformability, and consistent radial strength along with balanced stent deployment accuracy. Express LD is the first and only low-profile, premounted, balloonexpandable stent approved by the FDA for use in iliac arteries. The Express LD stent system is CE Mark approved and is currently approved for iliac use in a number of international markets. The company said it plans to launch the product immediately in the United States.

Engage and Engage TR Introducers
St. Jude Medical, Inc. (St. Paul, MN) recently 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 new Engage family of introducers helps to set the stage for a successful procedure by reducing the number of potential variables that can affect patient outcomes,” Dr. Javier Goicolea from Hospital Puerta de Hierro in Majadahonda, Spain, said.


EURO INNOVATIONS

Samba Stent
NovoStent Corp. (Mountain View, CA) recently announced receipt of CE Mark for its Samba stent and delivery system for the treatment of peripheral artery disease. The Samba stent was designed to treat a variety of disease states, including the highly varied presentation of atherosclerotic disease in the superficial femoral and popliteal arteries. It provides a unique combination of increased strength, flexibility, and vessel coverage.

With Samba, NovoStent has created a new product category that combines the best attributes of conventional stents and stent grafts, the company stated. The Samba stent has more than 50% metal coverage, giving it the ability to hold back more disease than a conventional stent. However, unlike with a stent graft, patency of side branch arteries can be maintained. The Samba stent has an ultra-thin helical macrostructure that greatly exceeds the flexibility and radial strength of traditional stents and a microcell structure that can be tailored for different vascular anatomies. NovoStent's stent and integrated mechanical power-assist delivery system is designed to provide accurate delivery in one continuous, steady motion.