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The Indigo Prostate Seeding Needle Cartridge System is a single use, disposable system which is intended as a convenience and radiation safety device for the purpose of loading a radionuclide brachytherapy source into the Índigo Prostate Seeding Needles for prostate brachytherapy. The Indigo Prostate Seeding Needle Cartridge System is indicated for use in conjunction with the Indigo Prostate Seeding Needle to deliver a radionuclide brachytherapy source for permanent interstitial implantation in the prostate gland for the treatment of localized tumors which are of low to moderate radiosensitivity.

The Indigo Prostate Seeding Needle Cartridge System consists of two main components, a single use, disposable seed magazine with a stainless steel shield and a Polyglactin 910 (PG910) absorbable spacer, which is a small cylindrical pellet utilized to provide space between the radionuclide seeds as they are implanted into the body. Both devices are intended to be used only in conjunction with Indigo Prostate Seeding Needles.

The Indigo 830e LaserOptic ™ Treatment System is intended to be used in the contact mode to photocoagulate, vaporize/ablate soft tissue (muscle, connective tissue, organ), and in the contact or non-contact mode for cutting, excision, incision, and coagulation of soft tissue in both open or closed surgical procedures. The Índigo 830e LaserOptic™ Treatment System with Diffuser-Tip™ Fiberoptic is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in total volume from 20-85 cc and for general surgery, general urological and gastroenterological procedures including the incision, excision, and ablation of soft tissues; and coagulative necrosis and interstitial laser coagulation of soft tissues.

The Índigo Diffuser- Tip™ Fiberoptic is a sterile, single-use, disposable fiberoptic which is 3 meters in length with a light-diffusing section at the distal tip. The device is designed to deliver energy from the Indigo Model 830e diode laser only and bears a unique connector for coupling to the 830e laser at the proximal end. Modifications have been made to increase the resistance to breakage of the fiberoptic and improve the manufacturability of the device. None of the changes affect the function, intended use, or overall design of the fiberoptic or of the Indigo LaserOpticTM Treatment System.

The Indigo 830e LaserOptic Treatment System with Diffuser-Tip™ Fiberoptic is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in total volume from 20-85 cc and general surgery, general urological and for for gastroenterological procedures including the incision, excision, and ablation of soft tissues; and coagulative necrosis and interstitial laser coagulation of soft tissues.

When used as a general surgical instrument, the laser is able to provide power to cut or coagulate tissues. When used as a coagulating device, the Indigo laser in conjunction with a diffusing fiberoptic provides interstitial laser coagulation. The process of interstitial laser coagulation relies on quickly elevating tissue to a temperature range (Appox. 60 to 100°C) where tissue necrosis rapidly occurs, but below temperatures at which carbonization begins.

When used as a general surgical instrument, the laser is able to provide power to cut or coagulate tissues.

The Indigo laser in conjunction with a diffusing fiberoptic provides interstitial laser coagulation.