There seems to be a general consensus that monorails are the primary type of balloon in Europe while over-the-wire balloons are preferred in the U.S. Can someone explain why there is such a distinct difference between the two markets?
FDA Clears Palmaz-Schatz(R) Crown Stent For Coronary Patients
Enhances Ease and Accuracy of Implant Procedure; Provides Greater Deliverability
MIAMI, Dec. 22 /PRNewswire/ -- Cordis Corporation today reported it received approval from the U.S. Food and Drug Administration to market the Palmaz-Schatz(R) CROWN balloon-expandable Stent. Premounted on Cordis' new PowerGrip(TM) Stent Delivery System -- a high-retention, high-pressure sheathless balloon catheter -- the CROWN Stent is a new medical device representing a significant technological advance over first-generation stents for use in treating plaque build-up and blockages in coronary arteries. Cordis Corporation is a Johnson & Johnson (NYSE: JNJ - news) company.
Numerous clinical studies have shown that stent procedures significantly reduce the potential of re-hospitalization by more than 30 percent for recurring blockage or re-narrowing (restenosis) of coronary arteries, which often occurs in patients after balloon angioplasty. Introduced in the U.S. by Johnson & Johnson in 1994, stents represent breakthrough technology for treating vascular disease. To date, more than one million original Palmaz-Schatz Coronary Stents have been implanted in patients around the world.
``The Palmaz-Schatz CROWN Stent and its new, improved delivery system represent exciting next-generation technology, permitting a faster and easier procedure, greater precision for physicians, and delivering continuous lesion coverage (site of narrowing or blockage),'' said J. Gary Jordan, President of Cordis Cardiology.
``The CROWN stent's unique design also retains all the positive features of the original Palmaz-Schatz Coronary Stent structure while enhancing visibility, providing unsurpassed radial strength, and excellent scaffolding uniformity to support a patient's artery,'' he continued.
``In addition,'' Mr. Jordan said, ``the new CROWN stent features an optimal metal-to-artery ratio and its PowerGrip Stent Delivery System is designed with exceptional stent retention characteristics, which eliminates the need for a sheath during the stent implantation procedure. Compared to our original stent, this feature allows access to even narrower vessel openings.''
In clinical studies, placement of the new CROWN stent in previously untreated coronary artery lesions resulted in similar (equivalent) improvement in blood flow, procedural success, and major cardiac events as compared to the original Palmaz-Schatz Coronary Stent.
``The CROWN is a strong and predictable stent, which has a lot to offer the interventionalist and patients alike,'' said David O. Williams, M.D., Professor of Medicine, Brown University, and Director of Interventional Cardiology at Rhode Island Hospital.
``This stent has good visibility, enabling precise and accurate positioning,'' he continued. ``The majority of the time the CROWN can be implanted with a single inflation, reducing the need for balloon exchanges and stent recrossing, which greatly improves the speed and efficiency of the procedure. The CROWN Stent is a valuable addition to the day-to-day practice of interventional cardiology.'' Dr. Williams served as lead investigator during CROWN Stent clinical trials.
A stent is a tiny, tubular-shaped, expandable steel scaffold. In an artery, it is delivered to the site of a closure or blockage by a balloon catheter, then expanded to the full diameter of the artery and remains permanently in place. By compressing obstructions and plaque buildup against the vessel wall, the stent restores blood flow through a lesion or narrowed region of the artery and helps prevent the vessel from re-narrowing or clogging.
``We believe the CROWN stent will best enable physicians to cost-effectively achieve optimal angiographic results, while simultaneously improving the simplicity and safety of the implant procedure,'' Mr. Jordan noted. ``Cordis offers a full range of stents in lengths as great as 30 mm, which dramatically reduces treatment costs by minimizing the number of stents and balloons required to complete a procedure.''
Since its establishment in 1959, Cordis Corporation, along with its subsidiaries, has been a pioneer in vascular disease management, and is the world's largest, most comprehensive developer and manufacturer of innovative products for interventional medicine and electrophysiology. In 1996, it merged with Johnson & Johnson to form Cordis, a Johnson & Johnson company, with approximately 5,000 employees worldwide.