Spectranetics Announces FDA Clearance of Peripheral Laser Atherectomy Devices for In-Stent Restenosis
24 July 2014 - 6:27AM
Turbo-Tandem® and Turbo Elite® are indicated to
treat peripheral ISR, the only on-label products in the
industry
EXCITE clinical trial proves safety, efficacy of
laser technology; uniquely positions SPNC to set new standard of
care while serving $350M U.S., $750M global market opportunity
The Spectranetics Corporation (Nasdaq:SPNC) today announced receipt
of U.S. Food and Drug Administration (FDA) 510(k) clearance of
their peripheral atherectomy products, Turbo-Tandem® and Turbo
Elite®, for the treatment of in-stent restenosis (ISR). The
clearance prompts a new standard of care in ISR treatment with
improved clinical outcomes.
"With mean lesion length at 20 centimeters, approximately
one-third of the patients being re-treated for ISR and also
approximately one-third with total occlusions, EXCITE represents a
very sick, real-world patient set," said Eric Dippel, MD, of
Genesis Heart Institute in Davenport, Iowa. "The highly superior
outcomes for both safety and efficacy and the delta in procedural
success rates between the two arms of the trial are compelling.
Given that a significant number of patients today are treated with
PTA alone with very poor outcomes, EXCITE demonstrates a proven
treatment algorithm that physicians and their patients need."
"FDA clearance of our peripheral atherectomy devices to treat
ISR is a landmark moment for Spectranetics and patients worldwide,"
said Scott Drake, President and CEO of Spectranetics. "We are the
only company with indicated devices, our primary competitors are
contraindicated; we possess clinical data that will change clinical
practice and a scaled commercial team to capitalize on this $750
million market opportunity."
FDA clearance comes on the heels of the EXCImer Laser Randomized
Controlled Study for Treatment of FemoropopliTEal (the arteries
above and behind the knee) In-Stent Restenosis (EXCITE ISR)
clinical findings. The study, which is the first multi-center,
randomized prospective trial ever conducted for the treatment of
ISR, demonstrated highly superior safety and efficacy of laser
atherectomy with adjunctive PTA compared with PTA alone. The trial
shows a 94% procedural success rate using laser atherectomy with
PTA versus 83% with PTA alone.
Notably, the average lesion length was approximately 20 cm as
compared to various stent IDE studies with average lesion lengths
of 4 to 6 cm. Additionally, a high number of complex or advanced
disease-state patients were enrolled in the trial, indicative of
success in treating all types of ISR lesions, including the most
complex cases. Complete results from the EXCITE trial have been
submitted to a peer-reviewed medical journal.
Implanting stents to open obstructed blood vessels is an
important treatment for patients suffering from Peripheral Artery
Disease (PAD). While stents deliver improved overall outcomes
compared to Percutaneous Transluminal Angioplasty (PTA) treatment,
restenosis (a return of the blockage) is very common, and stent
re-obstruction or ISR remains therapeutically challenging. Once ISR
develops, there is a 65% chance of recurrence after treatment with
PTA. PTA, also known as balloon angioplasty, is considered the
current standard of care. With over 115,000 ISR procedures
performed annually in the United States, Spectranetics is uniquely
positioned to capitalize on potential market opportunities of $350
million domestically and up to $750 million worldwide.
About EXCITE ISR
The EXCITE ISR trial was initially designed to enroll a maximum
of 318 subjects at up to 35 sites, randomized 2:1 treatment to
control. Earlier this year, Spectranetics announced early success
of the trial based on achieving highly significant statistical
superiority in both safety and efficacy among 250 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 major adverse events (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
Spectranetics develops, manufactures, markets and distributes
single-use 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.
Spectranetics recently acquired AngioScore, Inc., a leading
developer, manufacturer and marketer of cardiovascular, specialty
balloons.
The Company's Vascular Intervention (VI) products include a
range of laser catheters for ablation of blockages in arteries
above and below the knee as well as the AngioSculpt® scoring
balloon used in both peripheral and coronary procedures. 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.
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
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