(The following press release from Bayer was received by e-mail. It was not
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Not intended for U.S. and UK Media
Bayer’s AngioJet® Ultra thrombectomy system demonstrates efficacy in
treatment of peripheral arterial diseases
89 percent limb salvage rate in patients with acute limb ischemia / 84
percent of DVT patients maintained freedom from rethrombosis 12 months
following treatment / statistically significant improvements in patients’
quality of life seen at three, six and 12 months
Tarrytown, September 23, 2013 - 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.
"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."
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.
About the PEARL Registry
Conducted from January 2007 through June 2013 at 46 centers in four
countries the PEripheral Use of AngioJet Rheolytic Thrombectomy with a
Variety of Catheter Lengths (PEARL) was a two-phase registry that evaluated
the use of the AngioJet Thrombectomy System in the peripheral vascular
system of 952 patients. Forty-three percent of patients were treated for
arterial limb ischemia; 39 percent for DVT, 15 percent for thrombosed
hemodialysis access sites and three percent for other forms of thrombosis.
Safety and tolerability in the study were generally consistent with the
known profile of AngioJet or other endovascular procedures.
Data for the hemodialysis access subset will be presented in November at
VEITH Symposium and a full study report is in development and is expected
to be published next year.
About the AngioJet® Ultra Thrombectomy System
The AngioJet Ultra Thrombectomy System employs a unique technology to break
apart and remove blood clots from within peripheral vasculature. High-speed
saline jets inside the AngioJet catheter create a powerful low pressure
zone that pulls thrombus into the catheter and removes it from the body.
The core technology, AngioJet Thrombectomy, has been used in more than
600,000 cases worldwide and among the leading choices for eliminating large
thrombus burden. The AngioJet Ultra Thrombectomy Console features an
advanced control system that automatically detects the catheter model and
configures the console to meet the requirements of each catheter.
Throughout the procedure the Ultra Console monitors system performance to
ensure the procedure is running smoothly. Runtime and infused fluid volume
displays provide information and offer physician convenience. The Ultra
Series Thrombectomy Set integrates the pump and the catheter into a single
unit for fast and easy loading.
Indications, operating specifications and availability may vary by country.
Check with local product representation and country-specific Information
For Use for your country.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields
of health care, agriculture and high-tech materials. Bayer HealthCare, a
subgroup of Bayer AG with annual sales of EUR 18.6 billion (2012), is one
of the world’s leading, innovative companies in the healthcare and medical
products industry and is based in Leverkusen, Germany. The company combines
the global activities of the Animal Health, Consumer Care, Medical Care and
Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover, develop,
manufacture and market products that will improve human and animal health
worldwide. Bayer HealthCare has a global workforce of 55,300 employees (Dec
31, 2012) and is represented in more than 100 countries. More information
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