Search Results

The Hansen Medical Sensei® X Robotic Catheter System and Accessories are intended to facilitate manipulation, positioning and control of Hansen Medical's robotically steerable catheters for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems, using the following percutaneous mapping catheters: the Polaris-Dx™ Steerable Diagnostic catheters made by Boston Scientific Corporation and the Livewire™ Electrophysiology catheters made by St. Jude Medical.

The Hansen Medical Sensei X Robotic Catheter System and Accessories, when used in conjunction with compatible Hansen Control Catheters, are designed to facilitate manipulation, positioning and control of mapping percutaneous catheters within the atria of the heart. The fundamental concept of the system is based on a master/slave control system that enables and visualizes positioning of a steerable catheter tip at a desired point inside the heart, while enabling a physician to remain seated and away from the x-ray radiation source. The modifications to the Sensei X Robotic Catheter System include a series of software enhancements and a new E-Stop button.

Silicone Nasal Implant - For the augmentation or reconstruction of the nasal contour Silicone Malar Implant – For the augmentation or reconstruction of the malar contour Silicone Chin Implant -- For the augmentation or reconstruction of the chin contour

Not Found

For the Augmentation or cosmetic alteration of the nasal shape or contour by straightening the nasal dorsum or widening the narrow nose.

The Monarch Nasal Implant is a Class II Device. The Monarch Nasal Implant is available in 48mm and 44mm lengths and is 1cm wide at the ends. The thickness is 1.5mm to 2mm around the edges. The Monarch Nasal Implant may be inserted via three approaches: Transcutaneous, Intercartilaginous Approach and The Open Technique. The Monarch Nasal Implant is comprised of ePTFE and Medical Grade Titanium Alloys.

HANSON SCAR ADE is indicated for the topical management of keloid and hypertrophic scars

HANSON SCAR ADE is a topical gel made from silicones. HANSON SCAR ADE is intended for use in managing would and keloid scarring resulting from surgery, laser abrasion, chemical peels and other trauma. This product is offered non-sterile. For convenience it is packaged in half ounce and one ounce plastic tubes. Each tube will have Directions for Use, and Cautions. HANSON SCAR ADE is indicated for use to aid associated erythema or discoloration of scars. HANSON SCAR ADE is applied to the scar in a thin coat and excess is wiped away with a tissue. HANSON SCAR ADE is to be used on healed scars, in the case of surgery typically after 10 days from surgery. The product is not to be used on open wounds. Discontinue use if any infection is suspected, and obtain professional health care assistance.

The Hanson Medical Calf Implant (Silicone Carving Block) is for augmentation and reconstructive surgery. The Hanson Calf Implant will be carvable, allowing the physician to customize the device shape for muscular defects.

Hanson Medical Calf Implants are intended for augmentation, or as reconstruction to minimize muscular defects. The Hanson Calf Implant is carvable, allowing the physician to adapt the device shape to individual patient contours. They are manufactured using heat cured, medical grade, two part. liquid silicone system (LSR), silicones that meet FDA requirements for replacement of Dow's discontinued medical grade silicone analogues. Hanson Calf Implants will be offered non-sterile. The implants will be packaged in autoclavable peel pouches labeled with a detachable traceability tab for patient record files. Autoclave sterilization details are provided in the package insert. The implants are finally boxed with package insert materials and labeled for shelving and shipping traceability.

The Hanson Medical Gluteal Implant (Silicone Carving Block) is for augmentation and reconstructive surgery. The Hanson Gluteal Implant will be carvable, allowing the physician to customize the device shape for muscular defects.

Hanson Medical Gluteal Implants are intended for augmentation, or as reconstruction to minimize muscular defects. The Hanson Gluteal Implant is carvable, allowing the physician to adapt the device shape to individual patient contours. They are manufactured using heat cured, medical grade, two part, liquid silicone system (LSR), silicones that meet FDA requirements for replacement of Dow's discontinued medical grade silicone analogues. Hanson Gluteal Implants will be offered non-sterile. The implants will be packaged in autoclavable peel pouches labeled with a detachable traceability tab for patient record files. Autoclave sterilization details are provided in the package insert. The implants are finally boxed with package insert materials and labeled for shelving and shipping traceability.

The intended use of the Hanson Pectoralis Implant is augment or reconstruct the male chest by inserting the implant under the pectoralis muscle usually through a transaxillary incision. The proposed device can also be used for the correction of surface defects resulting from congenital anomalies such as depressions secondary to Poland's Syndrome. This product will be delivered non sterile. Silicone Carving Blocks are to be used for augmenting the chest by placing the implant in the submuscular space via a trans-axillary incision. They can also be used to reconstruct the pectoralis depression of Poland's Syndrome (Congenitally Absent Pectoralis Muscle)

The Hanson Pectoralis Implant is made from the same Silicone liquid elastomer materials and manufacturing processes as the predicate device. The physical properties of this device are the same as the predicate device in that the same materials or equivalent materials will be used. These raw materials are the LSR 30 of Applied Silicone and the MED 4211 unrestricted silicone fluid of Nusil Technologies. The durometers or hardness (Shore A) will range from 5 to 30. The appearance is described as clear to slightly opaque. The raw materials for these blocks will be Applied Silicone's LSR series and Nusil Unrestricted MED 4211. Tensile strength from lot to lot average 600 PSI or greater. The percent elongation is over 400 percent. Each lot is certified and tested for compliance to the parameters set for in the raw material certifications for each lot tested by the manufacturer. The Chemical components of this device are polysiloxanes catalyzed by a two part system.

Durasil I (Short Term) nasal splinting, wound dressings, wound drains, covering for gastroschisis, suture bolsters, scar coverings, laboratory uses, temporary facilitation of osteogenesis, and guided tissue regeneration between the teeth and gingival margin, or external ear canal for example, temporary joint spacers, and other short term uses according to the surgeon's determination. Durasil II (Long Term) Nonreinforced - Tympanic membrane repair, dural covering .005 inch, nasal septal repair, tendon anastomosis, neural repair - . 007 inch. correction of strabismus .010 inch, repair - . 020 inch, orbital floor repair . 040inch, galea hemodialysis shunt anchors .060. Reinforced - Facilitation of osteogenesis . 007inch, repair of urethral strictures . 007inch, staged repair of omphalocoel .020inch, repair of orbital floor fractures .040inch.

Durasil I and Durasil II Silicone Elastomer Sheeting are made from a biocompatible silicone high consistency rubber, HCRP-50 made by Applied Silicone and Nusil Technologies' MED 4750. There is essentially no difference between these two products saving for the short term and long term indications which are for marketing considerations only. Durasil I and II are available in polyester mesh reinforced and nonreinforced in a variety of thicknesses. The silicone elastomer used to make this product have met all Biocompatibility Guidelines set for by FDA for the replacement of Dow Corning Products. These biomaterial standards exceed or meet Class VI USP Standards in that they include Teratogenicity, Mutagenicity, Carcinogenicity and Toxicity Testing. These referenced material characterizations are found in Applied Master File - MAF 607.

To augment or reconstruct the nasal contour

Duralastic Nasal implants are "L" shaped or straight with concave convex dorsal aspect which reached from the alar catilage to the radix. These silicone elastomer rubber implants are made from specially formulated silicone elastomers designed for implantation. The LSR 30 Implant Grade elastomer is Masterfiled at FDA and has been thoroughly tested for biocompatibility, mutagenicity, carcinogenicity, and cytotoxicity. These referenced material characterizations are found in Applied Silicone's Master File MAF-562 and Nusil Technologies's MAF 612 for their MED 4211 Silicone Rubber -Unrestricted. The Duralastic Nasal Implants will be provided sterile and nonsterile. Several biocompatible pigments are used to make the white and flesh tone versions of these implants.