The Spectranetics Corporation (Nasdaq:SPNC) today announced that
12-month data from the EXCITE ISR clinical trial were presented by
Craig Walker, MD, at New Cardiovascular Horizons (NCVH) in New
Orleans. Results of the landmark study show that Spectranetics'
laser atherectomy devices used with PTA (also known as balloon
angioplasty), are safer and more effective than PTA alone for
treating femoropopliteal (FemPop) in-stent restenosis (ISR),
demonstrating continued durability in 12-month results.
Dr. Walker presented the EXCITE ISR 12-month data as part of
NCVH's Global Summit on Advanced Aorto-Iliac and Femoral
Interventions for Peripheral Artery Disease (PAD) in New Orleans.
Critical data findings include:
- Treatment using Turbo-Tandem resulted in significantly less
residual stenosis and need for bailout stenting.
- 92.9% procedural success rate using Turbo-Tandem with PTA vs.
81.7% with PTA alone (p<0.01).
- Primary safety endpoint, major adverse events (MAEs) rates at
30 days 5.4% vs. 20.8% with PTA alone (p<0.001).
- Primary efficacy endpoint, freedom from target lesion
revascularization (TLR) through 6-months 78.3% vs. 58.9% with PTA
alone (p=0.002)
- Excimer laser atherectomy with adjunctive PTA was associated
with a 43% reduction in TLR through 12-months. (Hazard Ratio
0.57; 95% CI 0.38-0.84; p=0.005).
"This marks a major milestone for patients who suffer from
FemPop ISR. EXCITE ISR data shows compelling and durable 12-month
clinical results treating incredibly sick patients and sets a new
standard of care—one that will change clinical practice," stated
Dr. Walker, an EXCITE ISR Primary Investigator and Chairman of
NCVH. "Physicians demand proven solutions, and this transformative
trial—the only trial of its kind providing Level 1 data—commands
attention from the cardiovascular community on behalf of the
patients they treat. EXCITE ISR is having a lasting impact on
physician protocols while changing lives around the world."
The EXCImer Laser Randomized Controlled Study for Treatment of
FemoropopliTEal (arteries above the knee) In-Stent Restenosis
(EXCITE ISR) is the first of its kind, large multicenter,
prospective randomized trial ever conducted for the treatment of
FemPop ISR. In July 2014, Spectranetics received a U.S. Food and
Drug Administration (FDA) 510(k) indication of its peripheral
atherectomy products, Turbo-Tandem™ and Turbo-Elite™, to treat ISR.
Other atherectomy devices are not indicated or contraindicated to
treat ISR, uniquely positioning Spectranetics to capitalize on
potential market opportunities of $350 million domestically and up
to $750 million worldwide.
Implanting stents to open obstructed blood vessels is an
important treatment for patients suffering from PAD, a disease that
impacts 200 million globally. While stents deliver improved overall
outcomes compared to PTA treatment, restenosis (a return of the
blockage) is very common, and stent reobstruction or ISR remains
therapeutically challenging.
"This year alone, as many as 400,000 patients around the world
will receive stent implants to restore the flow of blood due to
complications from PAD. An estimated 30% to 40% of those stents
will develop restenosis, with a 65% chance of recurrence after
treatment with PTA," states Kim Bridges, Senior Vice President of
Sales and Marketing, Vascular Intervention, Spectranetics. "This
new EXCITE data validates the safety and superiority of laser plus
PTA, versus PTA alone, further differentiating our comprehensive
portfolio to provide the breadth of cross, prepare and treat
solutions that physicians need and patients deserve."
About EXCITE ISR
The EXCITE ISR trial was designed to enroll a maximum of 318
subjects at up to 40 sites, randomized 2:1 treatment to control
with predetermined statistical analyses at 200, 250 and 300
enrolled patients. In 2014, Spectranetics announced success of the
trial based on achieving highly significant statistical superiority
in both safety and efficacy among 252 patients. The treatment arm
is laser atherectomy combined with PTA and the control arm is PTA
alone. The primary efficacy endpoint is freedom from TLR through
six months. The primary safety endpoint is freedom from MAEs at 30
days. MAEs include all-cause mortality, major amputation in the
target limb, or TLR.
About PTA
PTA, also known as balloon angioplasty, is a minimally invasive
procedure used to open blocked or stenosed blood vessels. A balloon
catheter is placed at the blockage site and inflated to compress
the blockage against the vessel wall. While PTA tends to be a
temporary solution, it is considered the standard of care for
patients with stenosis, a narrowing of the blood vessels in the leg
due to PAD, or restenosis, a recurrence of a blockage following
treatment. When a stent is used and restenosis occurs, ISR can
develop.
About Spectranetics
SPNC develops, manufactures, markets and distributes medical
devices used in minimally invasive procedures within the
cardiovascular system. The Company's products are sold in over 65
countries and are used to treat arterial blockages in the heart and
legs and in the removal of pacemaker and defibrillator leads.
The Company's Vascular Intervention (VI) products include a
range of laser catheters for ablation of blockages in arteries
above and below the knee, the AngioSculpt® scoring balloon used in
both peripheral and coronary procedures and Stellarex™ drug-coated
balloon peripheral angioplasty platform, which received European CE
mark approval in December 2014. The Company also markets support
catheters to facilitate crossing of peripheral and coronary
arterial blockages, and retrograde access and guidewire retrieval
devices used in the treatment of peripheral arterial blockages,
including chronic total occlusions. The Company markets aspiration
and cardiac laser catheters to treat blockages in the heart.
The Lead Management (LM) product line includes excimer laser
sheaths, dilator sheaths, mechanical sheaths and accessories for
the removal of pacemaker and defibrillator cardiac leads.
For more information, visit www.spectranetics.com.
Safe Harbor Statement
This news release contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934 and the Private
Securities Litigation Reform Act of 1995. You can identify these
statements because they do not relate strictly to historical or
current facts. Such statements may include words such as
"anticipate," "will," "estimate," "expect," "look forward,"
"strive," "project," "intend," "should," "plan," "believe," "hope,"
"enable," "potential," and other words and terms of similar meaning
in connection with any discussion of, among other things, future
operating or financial performance, strategic initiatives and
business strategies, clinical trials, regulatory or competitive
environments, our intellectual property and product development.
These forward-looking statements include, but are not limited to,
statements regarding our competitive position, product development
and commercialization schedule, expectation of continued growth and
the reasons for that growth, growth rates, strength, integration
and product launches, and 2015 outlook including projected revenue
and expenses, net loss and gross margin. Such statements are based
on current assumptions that involve risks and uncertainties that
could cause actual outcomes and results to differ materially. You
are cautioned not to place undue reliance on these forward-looking
statements and to note they speak only as of the date of this
release. These risks and uncertainties may include financial
results differing from guidance, inability to successfully
integrate AngioScore and Stellarex into our business, market
acceptance of excimer laser atherectomy technology and our vascular
intervention and lead removal products, lack of cash necessary to
satisfy our cash obligations under our outstanding 2.625%
Convertible Senior Notes due 2034, our debt adversely affecting our
financial health and preventing us from fulfilling our debt service
and other obligations, increasing price and product competition,
increased pressure on expense levels resulting from expanded sales,
marketing, product development and clinical activities, uncertain
success of our strategic direction, dependence on new product
development, loss of key personnel, uncertain success of or delays
in our clinical trials, adverse results in any ongoing legal
proceeding, or any legal proceeding in which we may become
involved, adverse impact to our business of the health care reform
and related legislation or regulations, including changes in
reimbursements, continued or worsening adverse conditions in the
general domestic and global economic markets and continued
volatility and disruption of the credit markets, which affects the
ability of hospitals and other health care systems to obtain credit
and may impede our access to capital, intellectual property claims
of third parties, availability of inventory from suppliers, adverse
outcome of FDA inspections, the receipt of FDA approval to market
new products or applications and the timeliness of any approvals,
market acceptance of new products or applications, product defects,
ability to manufacture sufficient volumes to fulfill customer
demand, availability of vendor-sourced components at reasonable
prices, unexpected delays or costs associated with any planned
improvements to our manufacturing processes, and share price
volatility due to the initiation or cessation of coverage, or
changes in ratings, by securities analysts. For a further list and
description of such risks and uncertainties that could cause our
actual results, performance or achievements to materially differ
from any anticipated results, performance or achievements, please
see our previously filed SEC reports, including those risks set
forth in our 2014 Annual Report on Form 10-K. We disclaim any
intention or obligation to update or revise any financial or other
projections or other forward-looking statements, whether because of
new information, future events or otherwise.
CONTACT: COMPANY CONTACT
The Spectranetics Corporation
Guy Childs, Chief Financial Officer
(719) 633-8333
INVESTOR CONTACT
Westwicke Partners
Lynn Pieper
(415) 202-5678
lynn.pieper@westwicke.com
The Spectranetics Corp. (MM) (NASDAQ:SPNC)
Historical Stock Chart
From Mar 2024 to Apr 2024
The Spectranetics Corp. (MM) (NASDAQ:SPNC)
Historical Stock Chart
From Apr 2023 to Apr 2024