The Spectranetics Corporation (NASDAQ:SPNC) today announced U.S.
Food and Drug Administration (FDA) Premarket Notification 510(k)
clearance of the Bridge Occlusion Balloon for temporary vessel
occlusion in cardiac lead extraction procedures. The Bridge
Occlusion Balloon builds on the long-standing clinical success and
proven procedural safety of cardiac lead extraction. The device is
designed to dramatically reduce blood loss in the rare event of a
tear, including in the superior vena cava (SVC), providing a
“bridge” to surgical intervention.
Clearance of the Bridge Occlusion Balloon initiates a controlled
market release with full market launch at the Heart Rhythm
Society’s 37th Annual Scientific Sessions (HRS) in San Francisco,
May 4-7, 2016.
“The Bridge Occlusion Balloon represents the biggest
breakthrough in lead management in the past 20 years,” said Jude
Clancy, MD, Director of the Lead Management Program at Yale Medical
Group, New Haven, Conn., and Lead Physician Investigator who will
present clinical data on the Bridge Occlusion Balloon at HRS.
“I believe Bridge will have a major impact on the field. It is
imperative to have the right tools and techniques to support
procedural safety. Bridge empowers extractors to take life-saving
action while transitioning to surgical repair, driving positive
patient outcomes.”
An SVC tear occurs in less than one half of 1% of lead
extraction procedures. When it does, the Bridge Occlusion Balloon
is intended to provide temporary occlusion prior to a critical
surgical intervention by deploying in under two minutes, occluding
the SVC tear and stemming 90% of blood loss for at least 30
minutes.
“The Bridge Occlusion Balloon is a game changer for extractors
as well as the cardiac surgeons who support them,” said Roger
Carrillo, MD, FHRS, Chief of Surgical Electrophysiology, University
of Miami Hospital, Miami, Fla. “With Bridge in place, the surgeon
has a clear field of view of the repair site and can quickly take
the most appropriate steps for the patient.”
“Spectranetics was founded on a commitment to safe, predictable,
responsible, life-saving medical procedures, and Bridge further
affirms that commitment,” said Donna Ford-Serbu, Senior Vice
President of Sales and Marketing, Lead Management, Spectranetics.
“We constantly innovate for safety, through research and
development of new tools and techniques and the most comprehensive
physician training programs available. Bridge represents another
step in Spectranetics’ mission to improve patient care through
proactive lead management.”
About Lead Management
There are more than 7 million pacemakers and implantable cardiac
defibrillators (ICDs) implanted worldwide, 700,000 new devices
implanted each year and 1.5 million new leads implanted annually.
These devices and the leads that connect them to the heart need
ongoing management and maintenance. Sometimes this includes removal
due to lead damage, lead or device infection, or manufacturer
advisory. Laser lead extraction has been a treatment option for
more than 20 years. Multiple studies show a procedural success rate
of more than 97% demonstrating safety, effectiveness and efficiency
of laser lead removal. In 2014, Spectranetics introduced mechanical
tools into its comprehensive portfolio of lead management
solutions.
About Spectranetics
Spectranetics 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 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,” “would,” “plan,”
“believe,” “hope,” “enable,” “potential,” “aim” and other words and
terms of similar meaning in connection with any discussion of,
among other things, performance and market acceptance of the Bridge
Occlusion Balloon, 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, 2015 and
2016 outlook and projected result, 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 management 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, cost of and 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 clearance and other
regulatory approvals 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 Annual Report on
Form 10-K for the year ended December 31, 2014, and our Quarterly
Reports on Form 10-Q. 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.
Investor Relations Contacts
Zach Stassen, Sr. Director of Finance
investor.relations@spnc.com
(719) 447-2292
Jamar Ismail
investor.relations@spnc.com
(415) 513-1282
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