Bayer’s AngioJet Ultra thrombectomy system demonstrates efficacy in treatment of peripheral arterial diseases – Sep 23, 2013– Tarrytown, USA (Techreleased) – Final data from the first prospective, multi-center registry evaluating the safety and efficacy of Bayer’s AngioJet® Ultra Thrombectomy System in the treatment of peripheral venous and arterial diseases demonstrated an immediate improvement in blood flow in more than 90 percent of all vessels treated. The data showed an 89 percent limb salvage rate in patients with acute limb ischemia, while 84 percent of patients with deep vein thrombosis (DVT) were free from reoccurrance 12 months following treatment. Statistically significant improvements in quality of life also were demonstrated at three, six and 12 months. The first two subset analyses of the PEripheral Use of AngioJet Rheolytic Thrombectomy with a Variety of Catheter Lengths (PEARL) Registry were presented this week at the Cardiology and Interventional Radiology Society of Europe Annual Meeting (CIRSE) in Barcelona.

Bayer’s AngioJet Ultra Thrombectomy System
Bayer’s AngioJet Ultra Thrombectomy System

“The PEARL registry data has demonstrated that AngioJet alone or in combination with lytic agents is an effective treatment, with a favorable safety profile, in patients with acute, subacute and chronic DVT and limb ischemia,” said Alan Main, President of Bayer HealthCare’s Medical Care Division and Member of the Bayer HealthCare Executive Committee. “Treatment with the AngioJet may reduce the need and infusion time for catheter directed thrombolysis (CDT) which can help improve a patient’s quality of life and reduce the economic burden on the healthcare system.”

Limb ischemia

Among patients with arterial limb ischemia, there was an average 90 percent reduction of occlusion at procedure’s end. Angiography showed a 93 percent improvement in the 947 treated vessels (p<0.0001) with the majority of the patients (80 percent) with a procedural duration of less than 24 hours.

“Treatment with AngioJet is equally effective in acute and chronic thrombus, and notably there was a limb salvage rate of 89 percent among the acute arterial patients with Rutherford classifications of IIa, IIb and III,” said Andrej Klepanec, M.D., Ph.D., Department of Diagnostic and Interventional Radiology, National Institute of Cardiovascular Disease, Bratislava. Patients in the arterial arm who were followed one year post treatment maintained a statistically significant improvement in quality of life scores on both mental (p<0.0001) and physical (p<0.0001) components.

Deep vein thrombosis

Among patients with DVT venographic analysis showed a statistically significant improvement in the thrombus burden (97 percent of 1,295 treated vessels demonstrated improvement; p<0.0001), across all treatment techniques and regardless of when symptom onset commenced. The 371 DVT patients were followed three, six and 12 months post treatment to assess safety, clinical benefit and quality of life. One year post-treatment, 84 percent of DVT patients maintained freedom from rethrombosis and a statistically significant improvement in quality of life. Nearly 90 percent of patients were treated using pharmacomechanical techniques in which AngioJet is used to directly infuse the agent into the clot prior to deploying the device’s mechanical thrombectomy functionality. The use of AngioJet pharmacomechanical technique demonstrated a statistically significant reduction in CDT drip time with fewer bleeding complications as compared to previous studies*.

* Venous Registry or CaVenT trial.

PEARL Registry suggests potential to reduce cost of DVT treatment

Approximately 1 million people are treated for DVT in the US and Europe annually. The DVT arm of the registry suggests that AngioJet alone, or with lytic delivered through its power pulse technology, is as effective as standard of care for DVT which includes lytic administered by CDT, and reduces costly hospital intensive care unit (ICU) time. Lytic administration by CDT generally occurs in the ICU for an average of two days. For example, in the US where the average daily cost of care in the ICU is $5000 there may be a significant benefit for patients and the healthcare system by reducing or eliminating ICU-based CDT treatment.