|[March 30, 2014]
Acute Pulmonary Embolism Trial Confirms Safety and Efficacy of Ultrasound Accelerated Endovascular Thrombolysis
BOTHELL, Wash. --(Business Wire)--
EKOS Corporation, a BTG International group company (BTG plc (LSE:
BTG)), notes the presentation of the results of the SEATTLE II trial
this afternoon at ACC.14, the 63rd Annual Scientific Session
and Exposition of the American College of Cardiology in
Washington, DC in the United States. The results were presented by Dr.
Gregory Piazza, MD, Staff Physician, Cardiovascular Division, Brigham
and Women's Hospital and Instructor of Medicine, Harvard Medical School.
The SEATTLE II study is a prospective, single-arm, multi-center trial to
evaluate the safety and efficacy of ultrasound-facilitated
catheter-directed low-dose thrombolysis, using the EKOS EkoSonic®
Endovascular System, for treating 150 patients with acute massive (N=31)
or submassive (N=119) pulmonary embolism (PE). Chest computed tomography
had to demonstrate proximal PE and a dilated right ventricle (RV/LV
ratio = 0.9) for patients to be eligible to participate. A dose of 24 mg
tPA (thrombolytic) was used in the trial, administered either as 1
mg/hour for 24 hours with a unilateral catheter or 1 mg/hour/catheter
for 12 hours with bilateral catheters. The mean RV/LV ratio in the study
decreased from 1.55 pre-procedure to 1.13 at 48 hours post-procedure, a
difference of 0.42 (p<0.0001).
Massive PE has a mortality rate of about 52% at 90 days.1 In
the SEATTLE II study, there were 31 patients presenting with massive PE
manifested by syncope and hypotension. However, no patients with massive
PE died within the 30 day follow up period. Of 150 patients in the
overall study, only one death was directly attributed to PE.
There were no intracranial hemorrhages and no fatal bleeding events.
Major bleeds occurred in 17 patients and was comprised of one severe
bleed and 16 moderate bleeds. Six of the major bleeds occurred in
patients with co-morbidities known to be associated with an increased
risk of bleeding during thrombolytic therapy.
The abstract concluded that ultrasound-facilitated catheter-directed
low-dose fibrinolysis for acute PE minimizes the risk of intracranial
hemorrhage, improves RV function, and decreases pulmonary hypertension.
Samuel Z. Goldhaber, MD, Professor of Medicine, Harvard Medical School
and Director, Thrombosis Research Group, Brigham and Woman's Hospital
(Boston, MA), and Principal Investigator for SEATTLE II said, "This
trial represents a breakthrough in demonstrating the safety and efficacy
of thrombolytic therapy for acute PE. The reduction of the RV/LV ratio
by 0.42 is substantial and clinically significant, without any
intracranial hemorrhage and using a much reduced lytic dose. These
findings establish a new rationale for considering thrombolysis in both
massive and submassive PE."
Dr. Stavros Konstantinides, MD, Professor for Clinical Trials and Deputy
Scientific Director, Center for Thrombosis and Hemostasis, Johannes
Gutenberg University of Mainz, Germany, and principal investigator of
PEITHO trial explains, "Aside from the massive PE patients who are in
need of emergent therapy, the submassive PE patients while
hemodynamically stable exhibit an elevated risk of clinical
deterioration if managed conservatively, as observed in the PEITHO
trial. The SEATTLE II study presents promising data in support of a
catheter-based modality to provie rapid unloading of the right heart,
thus reducing the risk of further deterioration."
Matt Stupfel, General Manager at EKOS Corporation, added, "The recently
published ULTIMA trial results demonstrated that EKOS treatment was
clinically superior to anticoagulation with heparin alone in reversing
right ventricular dilation at 24 hours, without an increase in bleeding
complications. Together, the SEATTLE II and ULTIMA trial results provide
compelling evidence that treatment with the EkoSonic®
Endovascular System improves the standard of care for patients with
acute pulmonary embolism."
BTG is a growing international specialist healthcare company that is
developing and commercialising products targeting acute care, cancer and
vascular diseases. The company has diversified revenues from sales of
its own marketed products and from royalties on partnered products, and
is seeking to acquire new programs and products to develop and market to
specialist physicians. To find out more about the BTG International
group companies and our products, visit www.btgplc.com.
About EKOS Corporation and the EkoSonic®
EKOS Corporation, a BTG International group company, pioneered the
development and clinical application of ultrasound infusion technologies
in medicine, introducing its first system for the treatment of vascular
thrombosis in 2005. Today, interventional radiologists, cardiologists,
cardiothoracic and vascular surgeons at leading institutions around the
world use the EKOS EkoSonic® Endovascular System to provide
faster, safer and more complete dissolution of thrombus. To find out
more about the EKOS EkoSonic® Endovascular System, visit www.ekoscorp.com.
EKOS, EkoSonic, MicroSonic are the trademarks of EKOS Corporation, a BTG
International group company. BTG and the BTG roundel are registered
trademarks of BTG International Ltd in US, EU and certain other
territories and trademarks of BTG International Ltd elsewhere.
Statements of indications:
USA FDA Cleared Indications:
The EkoSonic® Endovascular Device is intended for controlled
and selective infusion of physician-specified fluids, including
thrombolytics, into the peripheral vasculature. The EkoSonic®
System is cleared for the infusion of solutions into the pulmonary
Not designed for peripheral vasculature dilation purposes. The system is
contraindicated when, in the medical judgement of the physician, such
procedure may compromise the patient's condition. See device
instructions for use for complete prescribing information.
The CE Mark (CE0086) has been affixed to the EkoSonic® and
MicroSonicTM products with the following indications for use:
The EkoSonic® Endovascular Device, consisting of the
Intelligent Drug Delivery Catheter (IDDC) and the MicroSonicTM
Device (MSD), is intended for controlled and selective infusion of
physician-specified fluids, including thrombolytics, into the peripheral
vasculature. All therapeutic agents utilized with the EkoSonic®
Endovascular System should be fully prepared and used according to the
instruction for use of the specific therapeutic agent.
The MicroSonicTM SV Endovascular Device is intended for the
controlled and selective infusion of physician specified fluids,
including thrombolytics, into the peripheral vasculature.
The EKOS EkoSonic® Endovascular System is intended for the
treatment of pulmonary embolism patients with = 50% clot burden in one
or both main pulmonary arteries or lobar pulmonary arteries, and
evidence of right heart dysfunction based on right heart pressures (mean
pulmonary artery pressure = 25mmHg) or echocardiographic evaluation.
Notes to Editors
Submassive Pulmonary Embolism (PE) definition - patients with pulmonary
embolism that have normal systemic blood pressure and confirmed heart
Massive Pulmonary Embolism (PE) definition - patients with pulmonary
embolism that have systemic hypotension (systemic blood pressure that is
<90 mmHg) and confirmed heart dysfunction.
rt-PA - recombinant tissue plasminogen activator - a recombinant protein
involved in the breakdown of blood clots.
RV/LV ratio is the extent to which right ventricle is dilated in
relation to the left ventricle. Also known as an indicator for the right
PE occurs in approximately 1 million patients in Europe annually and
600,000 in the US, causing or contributing to 200,000 deaths each year.
(According to http://www.sirweb.org/patients/deep-vein-thrombosis/
and company internal data.)
Pulmonary hypertension (PH) is increased pressure in the pulmonary
arteries. These arteries carry blood from heart to lungs to pick up
oxygen. It causes symptoms such as shortness of breath during routine
activity, tiredness, chest pain, and a racing heartbeat.
PEITHO trial - this trial confirmed the benefit of thrombolytic therapy
among submassive PE patients, but also demonstrated that systemic IV
infusion of thrombolytic drugs carries significant bleeding risk.
Syncope - transient loss of consciousness.
1. Acute pulmonary embolism: clinical outcomes in the International
Cooperative Pulmonary Embolism Registry (ICOPER), Goldhaber et al.
Lancet. 1999 Apr 24;353(9162):1386-9.
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