Frequently
Asked Questions on Oscor Pacing Leads
For detailed
user information, intended use and warnings for each product please
refer to the Instructions for Use.
For
additional questions please contact us at 727-937-2511.
Q: What kind of Polyurethane is Oscor using
in its Polyurethane Implantable Pacing Leads?
A: Oscor uses for almost 20 years Polyurethane
90A in almost all of its pacing leads. There was never a recall on any
Oscor all Polyurethane lead.
Q: What is the average complaint rate of
the Oscor Polyurethane leads since 1993?
A: Oscor uses polyurethane inner insulation
on most bipolar silicone as well as polyurethane leads. The overall
complaint rate on all models manufactured between Jan. 1985 and Sept.
2000 is 0.35%. An overall survival rate of 99.65%, which is a lot higher
than the industry standard of 95%.
Q:
Are Oscor pacing leads compatible to the current pacemakers from Medtronic,
Guidant, St. Jude Medical, ELA Medical and Biotronik?
A: Yes, all Oscor leads are featured with
a connector pin according to the IS-1 standard and therefore are compatible
with all pacemakers with IS-1 headers.
Q:
Does Oscor have Retractable Screw-In Active Fixation Implantable Pacing
Leads?
A: We have both screwdriver (ZY Series)
and connector pin driven active fixation leads (PY Series). Oscor also
offers a line of fixed Screw-In Permanent Pacing Leads (KY Series).
For detailed user information, intended use and warnings, please refer
to the physician's Instructions for Use.
Q:
Does
Oscor have a "Direct Drive" Active Fixation Implantable Pacing
Lead?
A: The "direct-drive" or "stylet-drive"
active fixation leads are our family of ZY retractable screw-in leads.
For more information about Oscor ZY leads click here. For detailed user
information, intended use and warnings please refer to the physician's
user manual.
Q:
Is the screw of the ZY Implantable Pacing Lead electrically active?
A: The helix (screw) of all ZY models is
not electrically active and serves mainly as a mechanical means to fixate
the lead tip.
Q:
How many turns of the Screwdriver Stylet of the ZY Implantable Pacing
Lead does it take to extract the screw?
A: Only three complete clockwise turns,
provided that the helix (screw) was completely retracted before. For
detailed user information, intended use and warnings please refer to
the physician's Instructions for Use.
Q:
How do I see under x-ray that the screw of the ZY Implantable Pacing
Lead is extracted?
A: On the fluoroscopic image of the ZY
lead, the tip appears to be a solid tip when the helix (screw) is retracted.
The same solid tip "breaks" into two pieces when the helix
is completely extended, giving the distal end the appearance of having
"three" electrodes.
NOTE: The ZY screw-in mechanism has a "unique" feature which
is called the "clutch-system". When a fully inserted screwdriver
stylet is turned counterclockwise for more than 4 turns, a slight clicking
sensation is "felt" in the stylet handle. This clicking sensation
tells the operator that the helix (screw) is now completely retracted.
Only then should the operator apply the recommended 3, and not more
than 3, clockwise turns to extend the helix for the final fixation.
For detailed user information, intended use and warnings please refer
to the physician's Instructions for Use.
Q:
Is the ZY Implantable Pacing Lead available in Polyurethane or Silicone?
A: The ZY lead is available with either
a silicone or a polyurethane outer insulation.
Q:
Is the ZY Implantable Pacing Lead available in a preformed J shape?
A: The ZY atrial lead has a preformed J
distal portion and is available in either a silicone or a polyurethane
outer insulation. The ZY is also available in a straight version for
placement in the ventricle. For detailed user information, intended
use and warnings please refer to the physician's Instructions for Use.
Q:
Does Oscor have a Connector Pin driven Active Fixation Implantable Pacing
Lead?
A: The PY and PR family of Oscor leads
are connector pin driven retractable screw-in leads. The stylets do
not activate the helix (screw) mechanism and are mainly used to guide
the tip of the lead to the desired location. For detailed user information,
intended use and warnings please refer to the physician's Instructions
for Use.
Q:
How many turns of the connector pin of the PY/PR Series Implantable
Pacing Lead does it take to extract the screw?
A: From a completely retracted to a fully
extended helix takes about 10 to 12 turns when the lead is implanted.
A demo dry run with the lead lengthwise on a flat surface, the total
amount of pin rotations for helix activation should not exceed 6 to
8 turns. For detailed user information, intended use and warnings please
refer to the physician's user manual.
Q:
How do I know that the screw of the PY Series Implantable Pacing lead
is retracted?
A: The packaged lead comes with the helix
(screw) completely retracted. Upon the activation of the helix the amount
of applied connector pin turns clockwise should be memorized. The same
amount of turns counterclockwise should be applied to offset the previously
used clockwise turns and vice versa.
Q:
Is the PY Implantable Pacing Lead available in Polyurethane or Silicone?
A: The PY/PR pacing lead is only available
with a silicone outer insulation.
Q:
Is the PY Implantable Pacing Lead available in a preformed J shape?
A: No, however the lead may be used either
in the atrium or ventricle by using the preformed J-stylet or the straight
stylet respectively. The stylet gives the lead the form it needs and
also serves as the guiding mechanism to direct the tip to the desired
location.
Q:
Is the screw of the PY Series Implantable Pacing Lead electrically active?
A: Yes, the screw/helix of the PY/PR lead
is electrically active. The PY lead has a proprietary "Anti-Chattering"
mechanism incorporated, which assures a consistent and permanent electrical
contact between the fixation screw and tip electrode.
Q:
Does Oscor have a preformed J tined Lead?
A: Yes, we have two bipolar Polyurethane/
Polyurethane leads: the RU..TJUSBV and the Petite™ JB Series,
plus two unipolar leads, the silicone RZ..TJV and the polyurethane RZ..TJUV.
Q:
Why is Oscor's helix screw so unique?
A: The helix (screw) is smaller in size
than most of our competitor's version, sturdy to keep the fixed tip
in place, but when accidentally pulled on, the screw actually straightens
out leaving the myocardial tissue in the myocardium, where it belongs.
For easy fixation, each screw is sharpened by a proprietary process
performed by experienced personnel out of the Swiss watch industry.
Q:
Does Oscor have any epicardial permanent pacing leads?
A: Yes, Oscor offers a complete line of
unipolar and bipolar epicardial suture-on permanent pacing leads, the
MP series. For more information about the Oscor MP lead, please click
here.
Q:
Does Oscor have an Implantable Lead Adaptor to adapt from a unipolar
6mm (Cordis) connector pin or a 5mm (Medtronic) connector pin to an
unipolar IS-1 connector pin?
A: Yes, this Adaptor model number is C/VS-10.
Oscor offers a complete line of upsizing and downsizing lead Adaptors
and extensions. For details, please click here.
Q:
Does Oscor have an Implantable Lead Adaptor to adapt from a unipolar
LV-1 (Guidant CS Lead) connector pin to a unipolar IS-1 connector pin?
A: Yes, this Adaptor model number is LV/VS-10.
Oscor offers a complete line of upsizing and downsizing lead Adaptors
and extensions. For details, please click here.
Q:
Does Oscor have an Implantable Lead Adaptor to extend from a unipolar
Is-1 connector pin to an unipolar IS-1 connector pin?
A: Yes, this Adaptor model number is VV-10.
Oscor offers a complete line of upsizing and downsizing lead Adaptors
and extensions. For details, please click here.
Q:
Does Oscor have an Implantable Lead Adaptor to connect two bipolar IS-1
leads to one bipolar IS-1 connector?
A: Yes, this Adaptor model number is 2BIS/BIS.
Oscor offer a complete line of upsizing and downsizing lead Adaptors
and extensions. For details, please click here.
Q:
Does
Oscor have a "longer" introducer set?
A: Yes, this product, the LLP-Long, a longer
version of our LLP introducer, has a 23cm long sheath instead of the
16cm sheath length of the standard LLP.
Q:
Does Oscor sell any Pacemakers?
A: Yes, Oscor does have a single chamber
external pacemaker, the PACE 101H, and a dual chamber external pacemaker,
the new PACE 203H. Oscor does not sell any implantable pacemakers.
Q:
What is unique about the Oscor Temporary Myocardial Heartwire or Pacing
Wire?
A: Oscor heartwires come in bipolar (TME
64/65/66 Series) as well as quadripolar versions (TME 227/228 Series).
Every version has a 2 mm connector pin Adaptor included within the sterilized
packaged. The unipolar contains one pin Adaptor and the bipolar has
two pin Adaptors. Each 2 mm pin Adaptor incorporates a protective cap,
which seals the unprotected pin from accidental contact. Oscor offers
several unique fixation mechanism into the myocardium.
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