St. Jude Receives Approvals for Cardiac Lead Placement Tools

St. Jude Medical is introducing new devices touted to offer better lead wigglin’ and jigglin’ in the cath lab:

The CPS Duo system is a combination of a hollow stylet and compatible guidewire. Stylets provide support and straighten the lead tip during implantation. Guidewires are used to access the desired location in the heart, and then function as a track over which the lead is advanced into the heart.
The CPS Duo system [pictured on right –ed.] guidewires provide flexibility and support, while the stylet provides stiffness needed to advance the lead and manipulate its tip. Together, the products provide greater maneuverability and control of the left-ventricular lead than either tool could supply alone. The system also features a radiopaque tip for visibility under fluoroscopy and a marker that indicates when the lead tip is bent 90 degrees, which aids in maneuverability.
The CPS Courier guidewire [pictured on top –ed.] also is designed specifically to overcome the challenges of delivering a lead to the heart’s left side. This guidewire features a kink-resistant core wire with a smooth transition toward the tapered end, which provides support for the lead. The guidewire also features a platinum coil for visualization under fluoroscopy, a shaping ribbon so it can be formed according to specific needs, and a polymer jacket, which provides a smooth surface for improved movement through both leads and heart vessels.
The CPS Duo system and the CPS Courier guidewire are designed to be used with the St. Jude Medical QuickFlex(R) and QuickSite(R) leads (both of which are used for heart failure patients).
The Mond stylet also is designed to aid the placement of leads to an alternate site within the lower chambers of the heart, specifically the right ventricular outflow tract (RVOT). Therapy delivered from the RVOT more closely replicates the normal function of the heart, compared to pacing in the lower portion of the right chamber (the apex), and recent publications have reported that pacing from the apex may have deleterious effects to the patient.
The Mond stylet is pre-shaped and features a three-dimensional curve designed to assist in the placement of pacing and defibrillation leads in the RVOT. To provide physicians with more control and options to steer the lead through the heart’s anatomy to the desired targeted lead position, the Mond stylet is available in different curves, configurations, degrees of stiffness and lengths. It is designed to enable physicians to find the target position, and smoothly place the lead and remove the stylet.

Press release: St. Jude Medical Announces FDA Clearance and European CE Mark Approval for Tools That Help Place Leads in Challenging Heart Anatomy …