TIDMBTG
RNS Number : 8184F
BTG PLC
22 May 2017
OPTALYSE PE Study Demonstrates Safety and Efficacy of Shorter,
Lower Dose EKOS(R) Therapy For Pulmonary Embolism
Bothell, WA, 22 May 2017: BTG plc (LSE: BTG), the global
specialist healthcare company, today highlights the results of the
OPTALYSE PE trial, presented at the American Thoracic Society
International Conference in Washington, D.C. The results show that
pulmonary embolism (PE) can be treated effectively with EKOS(R)
over a much shorter period and at safer thrombolytic doses far
below the current standard, which will allow for scheduling
flexibility and efficiencies in clinician time and drug costs.
OPTALYSE PE included 101 patients with acute proximal PE at 17
centers randomized to one of four cohorts. All patients received
therapeutic anticoagulation along with EKOS Acoustic Pulse
Thrombolysis(TM) Therapy. The first cohort received 4mg per
catheter of a standard clot dissolving medication called tissue
plasminogen activator (tPA) over 2 hours. The second cohort
received 4mg per catheter tPA over 4 hours. The third cohort
received 6mg per catheter tPA over 6 hours. The fourth cohort
received 12mg per catheter tPA over 6 hours.
All cohorts saw a significant reduction in the main indicator of
right heart strain from PE (measured as right ventricular to left
ventricular diameter ratio (RV/LV)) by approximately 23 to 26
percent. This is consistent with results achieved in previous
EKOS(R) studies when treatment was applied for 12 to 24 hours. The
OPTALYSE PE results also showed a very low bleeding rate of 3%
compared to 10% in the previous SEATTLE II study where patients
were treated with 24mg for 12 or 24 hours.
"OPTALYSE PE sets a new standard for PE treatment," said study
author Dr. Victor Tapson of the Pulmonary and Critical Care
Division at Cedars-Sinai Medical Center in Los Angeles. "This trial
builds on a growing body of clinical evidence, including the ULTIMA
and SEATTLE II studies, showing a significant reduction in
right-heart strain with shorter treatment durations and lower tPA
doses. In addition to moving patients out of danger more quickly,
hospitals can potentially save significant intensive care, drug and
clinician time and cost due to increased safety and shorter
treatment durations."
The study's authors include Dr. Tapson; Dr. Gregory Piazza and
Dr. Samuel Goldhaber of Brigham and Women's Hospital, in Boston;
Keith Sterling of Inova Alexandria Hospital, Alexandria, Virginia,
Dr. Kenneth Ouriel of Syntactx, New York; and Ping-Yu Liu of the
Fred Hutchinson Cancer Center, Seattle.
"EKOS(R) is the only device cleared for the treatment of
pulmonary embolism and with the OPTALYSE results, BTG is once again
demonstrating our commitment to advancing the treatment of PE,"
said EKOS Vice President and General Manager Matt Stupfel. "Now
patients can be treated in half the time and half the dose or less,
providing greater flexibility to clinicians, improved safety to
patients, and potential cost savings to hospitals."
About Pulmonary Embolism
Pulmonary Embolism (PE) is a condition that occurs when a piece
of a blood clot breaks off from a clot in the legs and travels
through the vasculature -- getting trapped in the Pulmonary
Arteries. When this happens the clot keeps blood from getting to
some areas of the lungs to receive oxygen. This may lead to
excessive strain the right side of the heart, ultimately leading to
heart failure and/or cardiovascular collapse. PEs can be
immediately fatal, but if diagnosed and appropriate therapy
started, mortality can be reduced from approximately 30 percent to
less than 10 percent.
About the EkoSonic(R) Endovascular System
The EKOS(R) system uses ultrasonic waves in combination with
clot-dissolving thrombolytic drugs to effectively dissolve clots
and restore healthy heart function and blood flow.
In clinical studies EKOS(R) therapy has been shown to speed
time-to-clot dissolution, increase clot removal and enhance
clinical improvement compared to either standard catheter-directed
drug therapy or thrombectomy. EKOS(R) therapy requires
significantly shorter treatment times and less thrombolytic
compared to standard catheter-directed drug therapy, lowering the
risk of bleeding and other complications.
About the ULTIMA and SEATTLE II Study
The ULTIMA and SEATTLE II studies were multi-center trials
looking at ultrasound-facilitated, low-dose thrombolysis for acute
massive and sub-massive pulmonary embolism. ULTIMA, a randomized
controlled study compared to anticoagulation, looked at 59 patients
across 8 centers and SEATLE II, a prospective single arm study,
looked at 150 patients across 22 centers. Identical to OPTALYSE PE,
efficacy was measured by a reduction in right heart strain and
safety was measured by major bleeding within 72 hours.
Both studies' results showed that EKOS(R) Therapy reduced RV/LV
ratio by 23% to 25% at 48 hours. The studies concluded that EKOS(R)
therapy for acute PE improves RV function and decreases pulmonary
hypertension and angiographic obstruction. By minimizing the risk
of intracranial bleed, they represented a potential "game-changer"
in the treatment of high-risk PE patients.
For further information contact:
BTG
Andy Burrows, VP Corporate & Investor Relations
+44 (0)20 7575 1741; Mobile: +44 (0)7990 530 605
Stuart Hunt, Investor Relations Manager
+44 (0)20 7575 1582; Mobile: +44 (0)7815 778 536
Chris Sampson, Corporate Communications Director
+44 (0)20 7575 1595; Mobile: +44 (0)7773 251 178
Greentarget Communications
Chris Gale, Vice President
+1-646-695-2883; Mobile: +1-203-570-4681
About BTG
BTG is a global specialist healthcare company bringing to market
innovative products in specialist areas of medicine to better serve
doctors and their patients. We have a portfolio of Interventional
Medicine products to advance the treatment of cancer, severe
emphysema, severe blood clots and varicose veins, and Specialty
Pharmaceuticals that help patients overexposed to certain
medications or toxins. Inspired by patient and physician needs, BTG
is investing to expand its portfolio to address some of today's
most complex healthcare challenges. To learn more about BTG, please
visit: btgplc.com. NA-EKO-2017-0496
This information is provided by RNS
The company news service from the London Stock Exchange
END
MSCPGUMUAUPMUBP
(END) Dow Jones Newswires
May 22, 2017 07:00 ET (11:00 GMT)
Btg (LSE:BTG)
Historical Stock Chart
From Apr 2024 to May 2024
Btg (LSE:BTG)
Historical Stock Chart
From May 2023 to May 2024