Making More Possible - Boston Scientific

Making More Possible
Boston Scientific’s 30 Innovations Series
Technologies that Changed the Medical Device Industry

Making More Possible
To commemorate Boston Scientific’s 30th Anniversary, we are pleased to present the “30 Innovations Series.” This series
highlights the Company’s most groundbreaking products, many of which have helped revolutionize the medical device
industry. Examples of two early products appear below, both conceived and launched by companies eventually acquired by
Boston Scientific. We hope you enjoy this celebration of our 30-year legacy of innovation as we continue making more
possible for patients and clinicians with technologies that make an impact across a range of therapeutic areas.
Soft-Steerable Catheter System
Introduced in 1969 by Medi-Tech (later part
of Boston Scientific’s Peripheral
Interventions business)
The original steerable catheter was a versatile
tool that permitted safe, rapid and minimally
invasive access to remote areas of the body
for a variety of diagnostic and therapeutic
procedures. The multi-functional platform
inspired a wide range of physician use,
although its greatest success lay with
interventional radiologists, who used it to
remove gallstones.
MAXILITH Pacemaker
Introduced in 1972 by Intec/CPI, later
Guidant (now part of Boston Scientific’s
Cardiac Rhythm Management business)
MAXILITH was the first lithium-iodine battery
powered pacemaker, a device used to restore
natural pacing in a heart that would otherwise
beat too slowly. The innovative battery allowed
the device to quadruple the typical longevity of
a pacemaker, increasing the amount of time
between replacements out to five years.

# 1 Peripheral Dilatation balloon
Introduced in 1979 by Medi-Tech*
* Later part of Boston Scientific’s Peripheral Interventions business
The original Medi-Tech peripheral dilatation
angioplasty balloon was made of polyethylene,
which offered performance advantages over
competitor’s vinyl balloons by being stronger
and less compliant. The polyethylene balloon
propelled Boston Scientific to market leadership
in peripheral angioplasty, allowing the Company
to eventually pursue market creation in other
fields, such as gastroenterology, cardiology
and urology.

# 2 Greenfield ® Vena Cava Filter
Introduced in 1980 by Kimray Medical, later Mansfield*
* Now sold by Boston Scientific’s Peripheral Interventions business
The Greenfield Vena Cava Filter is an
implantable filter used in peripheral intervention
procedures designed to prevent blood clots
from reaching the lungs, otherwise know as
pulmonary embolism. The filter is implanted in
more than 10,000 patients annually who are at
high risk for clotting, especially those receiving
knee and hip-replacement surgery, cancer
patients and trauma victims. Since its
introduction, the Greenfield Filter has been
implanted in more than 600,000 patients.

# 3 Pigtail Ureteral Stent
Introduced in 1981 by Van-Tec*
* Now sold by Boston Scientific’s Urology/Gynecology business
Pigtail Ureteral Stents were pioneered in the
early 1980s and were some of the first stent
products that employed a guide wire to aid in
delivery. The stents were used to hold open
obstructed ureters (the tube passing from each
kidney to the bladder). The product line was
expanded over time to include dilatation
catheters and stone removal equipment for
the kidneys.

# 4 Segura Basket
Introduced in 1984 by Van-Tec*
* Now sold by Boston Scientific’s Urology/Gynecology business
Named after inventor Dr. Joseph Segura, the
Segura Basket is a tiny receptacle used in lessinvasive
procedures for retrieving stones from
the kidney without requiring them to pass
painfully through the urinary tract. The baskets
are typically inserted via ureteroscope into the
kidney through the urethra or through a small
incision in the back. Boston Scientific still sells
versions of the original Segura Baskets today.

# 5 AID-B/BR and VENTAK ® Cardiac Devices
Introduced by Intec/CPI, later Guidant*
AID-B/BR Automatic Implantable
Defibrillators
Introduced in 1985
The AID-B/BR devices were the world’s
first FDA-approved automatic
implantable defibrillators (AID). They
were the first implantable devices with
adequate energy to terminate
ventricular fibrillation, thus warranting
the term defibrillator.
* Now part of Boston Scientific’s Cardiac Rhythm Management business
VENTAK ® Implantable Cardioverter
Defibrillators
Introduced in 1988
VENTAK was the first automatic
implantable cardioverter defibrillator
(AICD) device with programmable rate
detection. Initially developed as a
standard energy device, it was launched
two years later as the first
programmable high-energy device.

# 6 Tracker ® Microcatheters
Introduced in 1985 by Target Therapeutics*
* Now sold by Boston Scientific’s Neurovascular business
The Tracker Microcatheter family ignited the
field of interventional neurovascular procedures,
providing an interventionalist with the ability to
negotiate vascular bends and bifurcations in the
neurovasculature for the first time. This
innovation eventually led to an entire portfolio of
endovascular therapies for the treatment of
intracranial aneurysms, intracranial
atherosclerotic disease (ICAD) and acute
ischemic stroke.

# 7 Radial Jaw ® Biopsy Forceps
Introduced in 1990 by the Endoscopy business
The Radial Jaw Biopsy Forceps were the first
successful single-use forceps designed to
enable collection of large tissue specimens for
accurate diagnosis of suspicious areas in the
digestive tract. Everyday, more than 30,000
endoscopic procedures are performed using the
Radial Jaw Biopsy Forceps product family for
disease diagnosis. Today, the Radial Jaw
Biopsy Forceps device is in its fourth generation
and still holds the leading market share
position.

# 8 WALLSTENT ® and Ultraflex Stents
Introduced in 1990/1991 by the Endoscopy business
The WALLSTENT Endoprosthesis revolutionized the
palliation of patients with esophageal, colonic, duodenal,
biliary and pulmonary tumors. The Ultraflex colonic
and esophageal stent was introduced a year later,
featuring a double-cell design for control, flexibility, wider
diameters and longer lengths providing physicians with
more treatment options. This family of stents quickly
became the standard of care for the palliative treatment
of esophageal and colonic strictures, and are marketleading
examples of our 20-year commitment to
developing and improving endoscopic stent
technologies. Today, the WallFlex ® Metal Stent platform
represents our third generation of stents, designed to
improve performance with a low-profile delivery system,
enhanced flexibility, visibility and deployment control to
help facilitate new treatment options for patients.

# 9 ENDOTAK ® Cardiac Lead
Introduced in 1991 by CPI, later Guidant*
* Now sold by Boston Scientific’s Cardiac Rhythm Management business
ENDOTAK was the first FDA-approved
transvenous defibrillation lead system. The
innovative leads allowed application of the
AICD to a patient population not suited for
open-chest procedures, as had been required
up to that time. The ENDOTAK leads were
quickly adopted due to the ease of use while
maintaining the same survival statistics, and
they were soon recognized as nearly as
important as the AICD itself.

# 10 Rotablator ® Atherectomy System
Introduced in 1993 by Heart Technologies*
NEED IMAGE
* Now sold by Boston Scientific’s Interventional Cardiology business
The Rotablator is a high-speed, diamond-tipped drill
used in cases of diffuse coronary artery disease
where angioplasty and surgery are less effective.
The unique device is delivered via catheter to target
lesions where the rotating football-shaped burr
spins at approximately 200,000 revolutions per
minute, sanding away calcified (hardened) plaque
to open clogged arteries.

# 11 EPT-1000 Cardiac Ablation System
Introduced in 1994 by the Electrophysiology business
The EPT-1000 was the first temperaturemonitoring
cardiac ablation system approved by
the FDA. These devices are used to treat
people living with various cardiac arrhythmias -a
condition that afflicts well over two million
Americans -- by delivering radiofrequency (RF)
energy via an ablation catheter to render the
heart’s abnormal sites electrically inactive. Still
a market leader today, the EPT-1000 RF
Systems are used in more than 80 percent of
electrophysiology labs across the United States.

# 12 Guglielmi Detachable Coils (GDC ® )
Introduced in 1995 by Target Therapeutics*
* Now sold by Boston Scientific’s Neurovascular business
The GDC coil was the first detachable platinum
coil developed for the embolization of
intracranial aneurysms. This technology
revolutionized the endovascular treatment of
brain aneurysms and created an entire medical
specialty. Since its introduction, there have
been more than 1.75 million GDC coils
implanted in patients worldwide.

# 13 Blazer ® Temperature Ablation Catheter
Introduced in 1996 by the Electrophysiology business
The Blazer Temperature Ablation Catheter was
the first in a family of very successful cardiac
ablation products designed to treat common
cardiac arrhythmias such as atrial flutter and
ventricular tachycardia. The Blazer family of
catheters is designed to provide familiar,
accurate, predictable performance, which is
critical to a successful outcome. The Blazer
Catheter set the bar for ablation catheter
performance and has maintained a strong
leadership position in the EP field with more
than 50 percent U.S. market share to this day.

# 14 CRE Balloon Dilator
Introduced in 1998 by the Endoscopy business
The CRE Balloon Dilator was the first “through the
scope” balloon dilator to feature controlled radial
expansion to three distinct diameters at three
separate pressures in a single balloon. The
balloon’s rounded shoulders facilitate visualization
of the stricture during the dilation procedure. CRE
Balloons are still used extensively today to dilate
strictures in the esophagus, colon, and
gastrointestinal tract caused by cancers and other
life-threatening conditions.

# 15 Maverick ® PTCA Balloon Catheter
Introduced in 2000 by the Interventional Cardiology business
The Maverick Balloon Catheters are used in
angioplasty procedures to dilate narrowed
coronary arteries and/or to expand a stent to
improve blood flow. The Maverick family of
balloon catheters offered innovative features to
improve performance and physician ease of
use, and today Maverick remains an industryleading
coronary balloon platform.

# 16 Synchro ® Guidewires
Introduced in 2001 by the Neurovascular business
The Synchro Guidewire family represented an
evolution in torque transmission for
neurovascular guidewires. For many
physicians, this innovation was essential to
successfully navigate the tortuous anatomy of
the intracranial vasculature. The revolutionary
design of the Synchro Guidewires enabled
physicians to efficiently reach the target area
and deliver therapy.

# 17 Cutting Balloon Monorail Device
Introduced in 2002 by the Interventional Cardiology business
The Cutting Balloon Monorail Device is used in
coronary atherotomy procedures to treat
complex lesions that are often resistant to
conventional balloon angioplasty. The device
features tiny, longitudinally mounted
microsurgical blades (atherotomes) mounted to
the balloon surface. As the balloon is expanded,
the atherotomes score the lesions with
incisions, allowing the balloon to dilate the
vessel with less pressure. The device's
proprietary fold mechanism shields the blades
and protects the vessel wall as the catheter is
passed to and from the treatment site.

# 18 CONTAK ® CD
Introduced in 2002 by Guidant*
* Now sold by Boston Scientific’s Cardiac Rhythm Management business
CONTAK CD was the first FDA-approved
cardiac resynchronization therapy defibrillator
(CRT-D). These devices are designed for the
treatment of heart failure, a medical condition in
which the heart is unable to pump enough
blood. At the time, estimates indicated that the
condition affected more than 5 million people in
the United States and 6.5 million in Europe.

# 19 Neuroform ® Microdelivery Stent System
Introduced in 2002 by the Neurovascular business
The Neuroform Microdelivery Stent System
was the first intracranial stent used to assist in
the treatment of wide-necked aneurysms. Prior
to the introduction of the Neuroform Stent,
the treatment of wide-necked aneurysms
was extremely difficult and rarely treated
via endovascular therapy. With the Neuroform
Stent accurately placed in an intracranial
vessel, a neurointerventionalist can successfully
pack an aneurysm with embolic coils with
increasing levels of success. Since launch,
there have been more than 40,000 Neuroform
Stents successfully implanted worldwide.

# 20 TAXUS ® Express 2 Coronary Stent System
Introduced in 2004 by the Interventional Cardiology business
The TAXUS Express 2 Paclitaxel-Eluting Stent
System was Boston Scientific’s first drugeluting
coronary stent and it has been called
by many industry experts “the most
successful product launch in medical device
history.” Within its first few weeks after FDA
approval, the TAXUS Express Stent quickly
gained 70 percent market share, and in less
than one year the product reached an
impressive milestone of one million units sold.

# 21 Advantage ® Mid-Urethral Sling System
Introduced in 2004 by the Urology/Gynecology business
The Advantage System is the first in a series of
mid-urethral slings that provide alternative
approaches for the placement of mid-urethral
slings for the treatment of female stress urinary
incontinence. Each with its own delivery
approach, the mid-urethral sling line offers
flexibility for urologists, gynecologists and
urogynecologists to choose an appropriate
procedure based on patient needs.

# 22 Resolution ® Clip
Introduced in 2004 by the Endoscopy business
The Resolution Clip was the first hemoclip
device to provide definitive endoscopic
hemostasis (arrest of bleeding) to patients
impacted by bleeding in the GI tract. It is the
only mechanical clip on the market designed to
open and close up to five times prior to
deployment, enabling a physician to see the
effects of the clip before committing to use.
Resolution Clip is intended for hemostasis,
endoscopic marking, closure, and anchoring
jejunal feeding tubes.

# 23 Precision ® and Precision Plus Spinal Cord
Stimulator systems
Introduced in 2005/2007 by the Neuromodulation business
The Precision Plus Spinal Cord Stimulator
(SCS) system helps chronic pain patients by
delivering electrical impulses to the spinal cord
that mask pain signals to the brain. It is the
world’s first rechargeable SCS device, and the
first and only one that provides a dedicated
power source for each lead contact. The
Precision Plus system is engineered to deliver
superior outcomes by precisely targeting pain
and maintaining therapy over time, in a solution
designed to fit the patient’s lifestyle.

# 24 LATITUDE ® Patient Management System
Introduced in 2005 by Guidant*
* Now sold by Boston Scientific’s Cardiac
Rhythm Management business
LATITUDE is the industry's most rapidly adopted
wireless remote device management system for
virtually all ICD and CRT-D patients. This remote
monitoring technology enables patients to have their
heart and specific cardiac device status monitored
from the convenience of their home. The system also
detects clinical events between scheduled visits and
sends relevant data directly to a patient’s physician
and primary cardiologist, if appropriate. LATITUDE is
the industry’s first and only system to include optional
heart failure management tools, which include a
Bluetooth-enabled weight scale and blood pressure
monitor that are consistent with the American College
of Cardiology and American Heart Association
guidelines for managing heart failure patients.

# 25 Wingspan ® Stent System with Gateway ® PTA
Balloon Catheter
Introduced in 2005 by the Neurovascular business
The Wingspan Stent System is specifically
designed to treat Intracranial Atherosclerotic
Disease (ICAD). ICAD causes the tortuous and
fragile vessels in the brain to narrow, thus
resulting in restricted blood flow that can lead to
stroke or death. With the use of the Wingspan
Stent System and Gateway Balloon Catheter, a
neurointerventionalist can reopen the vessel
and restore healthy blood flow.

Carotid WALLSTENT
# 26 ® Monorail ® Endoprosthesis and
FilterWire EZ Embolic Protection System
Introduced in 2006/2008* by the Peripheral Interventions business
* The Carotid WALLSTENT was introduced in
2008 and the FilterWire EZ was introduced
in 2006.
The Carotid WALLSTENT and FilterWire EZ are
used together in carotid artery stenting
procedures -- a minimally invasive alternative to
surgery for treating blockages in the carotid
arteries. The Carotid WALLSTENT features a
closed-cell design, engineered for excellent
lesion coverage and angiographic results, while
the FilterWire EZ Embolic Protection System is
designed to capture plaque debris released
during the stenting procedure, preventing it from
traveling to the brain. Before its launch in the
U.S., the Carotid WALLSTENT became the
leading carotid stent in Europe and other
international markets due to excellent patient
outcomes and ease of use in complex anatomy.

# 27 iLab Ultrasound Imaging System
Introduced in 2006 by the Interventional Cardiology business
Boston Scientific was a pioneer in the
intravascular ultrasound (IVUS) imaging market,
developing its first device in 1989 and becoming
a market leader with successive product
launches. The iLab System was the first of its
kind, allowing direct installation into a cardiac
catheterization lab or radiology suite, enabling
physicians to quickly and easily incorporate
IVUS technology into their daily procedures to
assist with diagnosis within the coronary and
peripheral arteries, and aid in stent placement.

# 28 SpyGlass ® Direct Visualization System
Introduced in 2007 by the Endoscopy business
SpyGlass is the first single-operator
cholangioscopy system designed to provide
direct visualization throughout the entire
pancreatico-biliary system to enable physicians
to diagnose and treat a wide range of diseases,
including pancreatic cancer and stone disease.
The SpyGlass technology is also redefining
patient care by leveraging single-use
technology, providing everyday access to
physicians and potentially offering significant
procedural and clinical advantages over
conventional visualization methods.

# 29 PROMUS ® Coronary Stent System*
Introduced in 2008 by the Interventional Cardiology business
* The PROMUS Stent is a private-labeled XIENCE V ®
Everolimus-Eluting Coronary Stent System manufactured by
Abbott and distributed by Boston Scientific.
PROMUS is an everolimus-eluting coronary
stent built on a highly deliverable platform.
Shortly after its U.S. launch, PROMUS became
one of the best-selling drug-eluting stents on
the market. It also allowed Boston Scientific to
become (and remain) the only stent
manufacturer to offer two distinct drug-eluting
stent platforms (paclitaxel and everolimus).

# 30 COGNIS CRT-D and TELIGEN ICD
Introduced in 2008 by Cardiac Rhythm Management
The COGNIS cardiac resynchronization therapy
defibrillator and the TELIGEN implantable
cardioverter defibrillator are the world’s smallest
and thinnest high-energy devices, representing
entirely new platforms to treat heart failure and
sudden cardiac death. Both devices offer
innovative features based on substantial
engineering advances, including extended
battery longevity, self-correcting software and
improved programming technology.

Caution:
Prior to using any Boston Scientific device, refer to specific product
packaging for complete indications for use, contraindications, warnings,
precautions, potential adverse events and instructions for use.
Boston Scientific Corporation
One Boston Scientific Place
Natick, MA 01760-1537
www.bostonscientific.com
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