A Medical Device Daily

A new analysis of clinical experience involving the AngioJet thrombectomy system from Possis Medical (Minneapolis) was presented during last week's EuroPCR conference in Paris.

When large blood clots, or thrombus, are removed from coronary arteries using the AngioJet system prior to placement of drug-eluting stents (DES), patient outcomes are improved, according to findings presented by Dr. Georgios Sianos, MD, interventional cardiologist at the Thoraxcentre at Erasmus University (Rotterdam, the Netherlands).

Sianos discussed a retrospective analysis of 900 patients who presented with acute myocardial infarction (AMI) and received immediate treatment with primary angioplasty and DES implantation.

Of these patients, 30% were determined to have large thrombus. Out to two years after their treatment, these patients had a higher frequency of subsequent serious cardiac complications than the patients presenting with small thrombus, confirming that large thrombus is a serious risk factor for heart attack victims.

Based on the data, Sianos proposed a new simplified and clinically validated thrombus classification in AMI patients.

Additional examination of the large thrombus patient group showed that of those who were stented without first removing the thrombus, 8.2% experienced in-stent thrombosis during the follow-up period, a serious and potentially fatal complication.

The analysis also revealed what Possis characterized as “very encouraging findings” in the group of patients with large thrombus who received AngioJet thrombectomy before DES placement. “With two years of follow-up, the patients with large thrombus who were treated with rheolytic thrombectomy therapy prior to stenting had no occurrence of in-stent thrombosis,” said Sianos. “Thrombus removal is highly advised in patients with AMI and large thrombus burden before DES implantation.”

Bob Dutcher, president and CEO of Possis Medical, said, “[This research] reinforces other research findings that identify thrombus as a significant risk factor for subsequent complications and strongly suggests that, in the setting of a heart attack, removing large thrombus before treatment with drug-eluting stents produces safer long-term outcomes.”

The CLiRpath Turbo-Booster, developed by Spectranetics (Colorado Springs, Colorado) for the treatment of blockages in the superficial femoral artery (SFA), was featured in a live-case session at EuroPCR. The live case was performed at Leipzig Heart Center (Leipzig, Germany) and transmitted via satellite to the EuroPCR symposium.

The company said stand-alone results were achieved in two focal in-stent restenosis lesions after initial treatment with a 2.0 CLiRpath Turbo laser catheter followed by four passes with the Turbo-Booster system. The Turbo-Booster allows for controlled deflection of the tip of the laser catheter, enabling a larger channel to be created as compared with that created by the laser catheter alone.

The live case was performed by Craig Walker, MD, and Andrej Schmidt, MD.

Walker, president and medical director of the Cardiovascular Institute of the South (Lafayette, Louisiana), said, “This was a very extensive in-stent restenosis in a large artery in the upper leg, which represents one of the most challenging cases as the blockages often contain clot and plaque. The laser and new product system quickly and easily recanalized this lesion, leaving virtually no residual blockage and there was no evidence of any debris to the lower leg.”

Spectranetics is in the process of initiating the CELLO study using the Turbo-Booster system in the U.S. This single-arm study will take place in 10 to 15 centers, and will enroll about 100 patients. The company said it hopes to obtain FDA clearance for the device in 2007.

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