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The Blom-Singer® FirstFit™ Surgical Kit (FFSK) is indicated for use during surgical creation of primary or secondary tracheoesophageal puncture, dilation of the tracheoesophageal wall, and to guide the placement of the voice prosthesis for tracheoesophageal voice restoration following total laryngectomy. The FFSK contains a sterile single use indwelling Blom-Singer® Indwelling Voice Prosthesis device intended for voice rehabilitation after surgical removal of the larynx (laryngectomy). Cleaning of the voice prosthesis is performed by the patient while it remains in situ.

The FirstFit Surgical Kit (FFSK) is a kit for creating a primary or secondary TE puncture, with subsequent dilatation of that puncture to a width that facilitates placement of the included Blom-Singer® Indwelling Voice Prosthesis, cleared in K082206. The FFSK is for transient use as an aid to a surgical operation to puncture and stent the tracheoesophageal septum. The FFSK is provided sterile (by ethylene oxide) in a sealed tray, ready to be introduced into the surgical field. Additionally, it is used to guide voice prosthesis placement in a total laryngectomized patient as a primary or secondary procedure. Puncture and placement should take place in a sterile field with the patient being under anesthesia. The FFSK is designed for primary or secondary tracheoesophageal puncture (TEP) with retrograde voice prosthesis insertion. This kit includes: one (1) 13-gauge curved core puncture needle, one (1) 36-inch guidewire with rounded tips, one (1) pharynx protector tool with handle and notched cylinder, one (1) voice prosthesis inserter pre-loaded with a Blom-Singer® Indwelling Voice Prosthesis of the diameter and length specified on the package label. The Blom-Singer® Indwelling Voice Prosthesis devices (VP) are indwelling devices primarily made of silicone, designed to provide voicing after total laryngectomy. The voice prostheses are placed in a surgically created fistula between the trachea and esophagus in order to divert air through the prosthesis valve to create voicing. The use of an indwelling device means that routine removal for cleaning by the patient is not necessary, thus making it easier for the patient to maintain the device the risk of accidental dislodgment of the device.

The Steerable Introducer is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.

The Steerable Introducer consists of a single use, bi-directional steerable sheath connected to a handle with steering controls, a hemostasis valve with side port and 3-way stopcock, a tapered dilator and compatible guidewire. The device is provided sterile in a sealed Tyvek pouch and carton with IFU. The sheath distal tip and dilator shaft are radiopaque for visualization under fluoroscopy. The dilator is designed to accommodate a guidewire and includes a proximal hub with a female luer tapered fitting for flushing.

The 8.5F Steerable Introducer is intended to provide a conduit allowing introduction, removal, and exchange of compatible therapeutic and/or diagnostic tools into the cardiovascular system while maintaining hemostasis. The device facilitates access to the left and right sides of the heart, including left atrium and left ventricle access through the interatrial septum. It features a deflectable distal tip that enables guidance of compatible tools. The Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

The steerable introducer consists of a steerable sheath connected to a handle with steering controls, a hemostasis valve with sideport featuring a 3-way stopcock, and a tapered dilator. The device is provided sterile in a sealed Tyvek pouch and carton with IFU. The sheath distal tip and dilator shaft are radiopaque for visualization under fluoroscopy. The dilator is designed to accommodate a guidewire, with size compatibility as indicated on the product labels. A dilator hub is provided with a female luer tapered fitting for flushing (see illustration below). The device includes a side port with stopcock to allow fluid injection and sampling, drip infusion, pressure monitoring, flushing and aspiration. The steerable introducer usable length, lumen length, outer diameter, curl size, and inner diameter/tool compatibility specifications are indicated on the product labels. The distal end of the steerable sheath features 180° bi-directional deflection to provide directional control to the compatible tools interacting with the device.