Medical Device Daily Associate
If all goes according to plan, the Abbott Vascular Devices (Redwood City, California) division of Abbott Laboratories (Abbott Park, Illinois) will be able to add another device to its vascular closure arsenal.
The company reported that it has submitted a premarket approval (PMA) application to the FDA for its StarClose Vascular Closure System, what it termed a "next-generation" vessel closure system specifically designed for the mechanical closure of femoral arteries following catheterization procedures, such as angioplasty and stent placement.
The StarClose is designed to quickly and securely deliver a flexible nitinol clip to mechanically appose or bind the surface of a femoral artery together following a catheterization procedure.
StarClose received CE certification in February 2004, and was officially launched outside of the U.S. last year.
Tony Chou, MD, an interventional cardiologist and general manager of vessel closure technologies at Abbott Vascular, told Medical Device Daily that if approved, the StarClose represents the next revolution in the company's vascular closure offerings.
"Physicians should always be on the lookout for technology that improves patient care," Chou said. "Our analysis has shown that StarClose is a device that was as safe as manual compression with an extra vascular approach and a design that could potentially minimize the risks associated with other methods of femoral artery closure."
Chou noted that the company already sells the Perclose suture-mediated closure system, which it acquired with its 1999 acquisition of Perclose (also Redwood City).
Integrated Vascular Systems (IVS; Sunnyvale, California) originally developed the StarClose clip technology, and Abbott acquired IVS in September 2003 (Medical Device Daily, Sept. 30, 2003).
Another product in the company's vascular closure portfolio is the Chito-Seal topical hemostasis pad, which expedites clot formation and accelerates hemostasis. That product was launched in 2002.
If the StarClose is approved by the FDA, Chou said that Abbott Vascular will be able to offer U.S. interventionlists the options of both a suture and clip – similar to how a vascular surgeon would approach the vessel to obtain a secure and clinically effective closure.
The StarClose delivers an extravascular nitinol clip to close 6 Fr puncture sites in the femoral artery via a through-the-sheath (TTS) approach, leaving nothing behind in the vessel that could cause blockages later.
Chou said that TTS expedites the closure procedure by removing extra guide wire insertion and sheath exchange steps and minimizing exposure of the sterile clip to the skin, allowing interventionalists to use the very same pathway established during the catheterization procedure to deliver the flexible nitinol clip directly to the puncture site.
The StarClose Vascular Closure System consists of the Clip Applier, Introducer Set and Exchange System.
Since the StarClose works from an extrovascular perspective, Chou said the system is able to differentiate itself from other devices on the market by "leaving nothing behind" in the artery that could cause potential blockages later. He added that the system brings the tissue edges together, "which we think is a very favorable way of healing the tissue and the injury that is caused by arteriotomy [insertion of the catheter]."
While Chou said that utilizing either the Perclose or StarClose device would be a matter of surgeon choice, "All doctors demand a safe and effective device, and we believe both StarClose and Perclose are very safe and effective."
Abbott submitted its PMA for the StarClose based on the results of its CLIP (Clip cLosure In Percutaneous Procedures) clinical study, which compared the safety and effectiveness of StarClose vs. manual compression to control hemostasis following a catheterization procedure.
The CLIP clinical trial data submitted to the FDA consisted of a study of 208 patients enrolled at 17 U.S. sites who were randomized to receive either StarClose (136 patients) or manual compression (72 patients) following catheterization. The study met its primary endpoints, with no major vascular complications occurring in either the study arm or the control (manual compression) arm.
A median time to hemostasis of 16.8 seconds was achieved in the StarClose group vs. 15 minutes in the manual compression group. Preliminary data from the CLIP study also suggested that use of StarClose allowed for earlier ambulation or mobilization (two hours earlier) and earlier discharge (two hours earlier) of patients than with standard compression.
"In the CLIP study, StarClose had an outstanding safety profile," said Jim Hermiller, MD, of The Care Group at St. Vincent's Hospital (Indianapolis), one of two co-principal investigators for the CLIP study. "The rate of vascular complications with StarClose was zero – equal to standard-of-care manual compression, but preliminary results showed that closing a vessel with StarClose allowed patients to get out of bed and be discharged sooner than with manual compression."
The American Heart Association (Dallas) has estimated that more than 70 million Americans have some form of cardiovascular disease. Nearly 4 million catheterization procedures were performed in the U.S. in 2002, including angioplasty and diagnostic cardiac catheterizations, and the number of cardiac catheterizations has increased over 400% in the last 20 years.
Other companies offering vascular closure technology include Medtronic Vascular (Santa Rosa, California) division Angiolink (Taunton, Massachusetts), with the FDA-approved Expanding Vascular Stapling Closure system, and St. Jude Medical (St. Paul, Minnesota), which acquired and has substantially grown the revenues for the AngioSeal collagen product originally developed by Kensey Nash (Exton, Pennsylvania).