
 
 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. 
    
    
  
