Market Overview

OPTALYSE PE Results Published in JACC: Cardiovascular Interventions


BTG plc (LSE: BTG), the global healthcare company, highlighted the
publication of OPTALYSE PE trial results in JACC:
Cardiovascular Interventions
. The published findings further confirm
that bilateral pulmonary embolism (PE) treated in as little as 2 hours
with EKOSAcoustic Pulse Thrombolysis™ therapy shows
significant improvement in RV/LV ratio and with a very low one-year
mortality rate of 2% and an equally low one-year recurrent PE rate of
2%. This is with considerably less tissue plasminogen activator (tPA)
than used in previous studies1, as low as 8mg total.

"The publication of OPTALYSE PE further solidifies these findings as a
potential 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. "The body of clinical evidence, including
the ULTIMA and SEATTLE II studies, reveals an opportunity to advance PE
patient care with more flexible and efficient deployment of intensive
care, drug and clinician time, along with enhanced safety and speed."

OPTALYSE PE included 101 patients with acute proximal PE at 17 centers
randomized to one of four cohorts of EKOS® therapy. The first
cohort received 4mg per device of a standard clot dissolving medication
called tissue plasminogen activator (tPA) over 2 hours. The second
cohort received 4mg tPA per device over 4 hours. The third cohort
received 6mg tPA per device over 6 hours and the fourth cohort received
12mg tPA per device for 6 hours.

All four cohorts saw 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%. This is
consistent with previous studies where treatment took place from 12 to
24 hours. The OPTALYSE PE results included a very low bleeding rate of
3% compared to 10% in the SEATTLE II study, in which patients received
treatment with 24mg for 12 or 24 hours. One-year data from OPTALYSE PE
demonstrates improved quality of life of over 30%.

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.

"The published OPTALYSE PE study shows EKOS® therapy achieves
similar efficacy as previously successful EKOS trials, as well as better
safety in as little as 2 hours and with low tPA doses," said Lynn Allen,
Vice President of Clinical Affairs for BTG Vascular. "The favorable
long-term mortality and QOL data and low recurrent PE rate after EKOS
therapy are compelling findings when you consider that treating with
systemic thrombolysis or anti-coagulation2, comparable trials
have found a one-year mortality at 8% to 10%."

A separate registry study underway, KNOCOUT PE is intended to measure
how institutions are adopting OPTALYSE PE and this new standard of care.
The study is expected to include as many as 100 centers globally and is
currently enrolling.

About the EkoSonic®
Endovascular 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® 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
therapy requires significantly shorter treatment times and less
thrombolytic compared to standard catheter-directed drug therapy,
lowering the risk of bleeding and other complications.

Product availability varies by country. Caution: Federal (USA) law
restricts this device to sale by or on the order of a physician. Prior
to use, please refer to the applicable Instructions for Use (IFU) for
complete product indications, contraindications, warnings, and

About the OPTALYSE PE, ULTIMA and SEATTLE II studies

studies prospective multi-center trials examining
ultrasound-facilitated, catheter-directed thrombolysis using a low dose
of a standard clot dissolving medication called tissue plasminogen
activator (tPA) to treat both acute massive and submassive pulmonary

ULTIMA, a randomized controlled study comparing EKOS®
therapy to anticoagulation, looked at 59 patients across eight centers
and proved that the EKOS
® regiment was superior
to anticoagulation alone.

SEATTLE II, a prospective single arm study, looked at 150 patients
across 22 centers and demonstrated improvement in RV/LV ratio, pulmonary
hypertension and angiographic obstruction with EKOS

OPTALYSE PE included 101 patients with acute proximal PE at 17
centers randomized to one of four treatment cohorts – with cohorts
ranging between 2-6 hours in treatment duration and from 4-6mg/tpA total
per device. 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. The OPTALYSE PE results also showed a very low bleeding rate of
three percent. Beyond the acute results, echocardiograms were provided
at four hours, 48 hours, 30 days, 90 days, and at one year post-therapy.
The initial significant reductions in RV/LV continued to improve in all
cohorts through one year. Multiple quality of life measures showed key

About BTG

BTG is a global healthcare company focused on Interventional Medicine.
Our innovative medical technology helps physicians treat their patients
through minimally invasive procedures. We have a growing portfolio of
products that advance the treatment of cancer, vascular conditions and
severe emphysema. BTG's Pharmaceuticals business provides products that
help patients overexposed to certain medications or toxins. To learn
more about BTG, please visit:

  1. Piazza, G., et al., A Prospective, Single-Arm, Multicenter Trial of
    Ultrasound-Facilitated, Low-Dose Fibrinolysis for Acute Massive and
    Submassive Pulmonary Embolism: the Seattle II study." Journal of the
    American College of Cardiology: Cardiovascular Interventions 2015; 8:
  2. Konstantinides, MD, et al, "Impact of Thrombolytic Therapy on the
    Long-Term Outcome of Intermediate-Risk Pulmonary Embolism" Journal of
    the American College of Cardiology; vol 69, pp.1536-1544, 2017.

View Comments and Join the Discussion!