Warning; Device Description; Contents; Intended Use/Indications For Use - Boston Scientific Rotablator Gebrauchsanweisung

Rotablator
Rotational Atherectomy System
RotaLink Burr
™
Exchangeable Burr Catheter
RotaLink Plus
™
Pre-Connected Exchangeable Burr Catheter
and Burr Advancing Device
ONLY
Caution: Federal Law (USA) restricts this device to sale by or on the order of a
physician.

WARNING

Contents supplied STERILE using an ethylene oxide (EO) process. Do not use
if sterile barrier is damaged. If damage is found, call your Boston Scientific
representative.
For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing
or resterilization may compromise the structural integrity of the device and/or
lead to device failure which, in turn, may result in patient injury, illness or death.
Reuse, reprocessing or resterilization may also create a risk of contamination of
the device and/or cause patient infection or cross-infection, including, but not
limited to, the transmission of infectious disease(s) from one patient to another.
Contamination of the device may lead to injury, illness or death of the patient.
After use, dispose of product and packaging in accordance with hospital,
administrative and/or local government policy.

DEVICE DESCRIPTION

The Rotablator Rotational Atherectomy System is a catheter-based angioplasty
device utilizing a diamond-coated elliptical burr at the tip of a flexible drive
shaft. Tracking coaxially over a guidewire and rotating at up to 190,000 RPM,
the burr ablates plaque into fine particles that are disposed of by the body's
reticuloendothelial system. The Rotablator Rotational Atherectomy advancer and
catheter are provided STERILE and non-pyrogenic unless the package has been
opened or damaged. It is intended for one procedure use only. Do NOT attempt to
reuse or resterilize it.

Contents

RotaLink Advancer
(1) RotaLink Advancer
RotaLink Plus
(1) RotaLink Plus Assembly
RotaLink Burr
(1) RotaLink Burr Exchangeable Catheter
™

INTENDED USE/INDICATIONS FOR USE

Percutaneous rotational coronary angioplasty with the Rotablator Rotational
Atherectomy System, as a sole therapy or with adjunctive balloon angioplasty, is
indicated in patients with coronary artery disease who are acceptable candidates
for coronary artery bypass graft surgery and who meet one of the following
selection criteria:
• Single vessel atherosclerotic coronary artery disease with a stenosis that can
be passed with a guidewire;
• Multiple vessel coronary artery disease that in the physician's judgment does
not pose undue risk to the patient;
• Certain patients who have had prior percutaneous transluminal coronary
angioplasty (PTCA), and who have a restenosis of the native vessel; or,
• Native vessel atherosclerotic coronary artery disease that is less than 25 mm
in length.

CONTRAINDICATIONS AND RESTRICTIONS

Contraindications

1. Occlusions through which a guidewire will not pass.
2. Last remaining vessel with compromised left ventricular function.
3. Saphenous vein grafts.
4. Angiographic evidence of thrombus prior to treatment with the Rotablator
System. Such patients may be treated with thrombolytics (e.g., Urokinase).
When the thrombus has been resolved for two to four weeks, the lesion may
be treated with the Rotablator System.
5. Angiographic evidence of significant dissection at the treatment site. The
patient may be treated conservatively for approximately four weeks to permit
the dissection to heal before treating the lesion with the Rotablator System.

RESTRICTIONS

1. Federal (USA) law restricts the use of this system to physicians who are
credentialed in angioplasty and who have attended the Rotablator System
Physician Training Program.
2. The minimum requirements (USA) for the primary operator of the Rotablator
System in the coronary arteries include:
• The physician must be accredited and qualified to perform PTCA at his/her
local institution.
• The physician must perform a minimum of 75 PTCAs per year as a primary
operator.
3. Governing law outside the USA restricts this device to sale by or on the order
of a physician.

WARNINGS

• The risks of Rotational Atherectomy can be reduced if the device and
associated accessories are used in the appropriate patient population by a
physician who has had adequate training.
• If the Rotablator advancer or catheter shows evidence of mechanical
failure at any time prior to or during the angioplasty procedure, immediately
discontinue use of the device and return it to Customer Service for evaluation.
Do NOT attempt to use a damaged Rotablator advancer or RotaLink catheter;
use may result in device malfunction and/or patient injury.
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