Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO: Yag/ND: Yag Surgical Lasers and Delivery

The modified and currently marketed Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including:

Ho:YAG - urology; urinary lithotripsy; arthroscopy; discectomy; endonasal surgery; gynecological surgery; and general surgery; and

Nd:YAG - urology; general surgery; gastroenterology; thoracic and pulmonary surgery; ENT surgery; podiatry; orthopaedics; and with limited indications in gynecology; neurosurgery; ophthalmology; and lumbar discectomy.

The modified and currently marketed Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers (and the delivery accessories that are used with them to deliver laser energy) are indicated for use in the performance of specific surgical applications in urology, urinary lithotripsy, arthroscopy/orthopaedics, discectomy, endonasal surgery/ENT surgery, gynecological surgery/gynecology, general surgery, gastroenterology, thoracic and pulmonary surgery, dermatology and plastic surgery, podiatry, and limited indications in gynecology, neurosurgery, ophthalmology, and lumbar discectomy as follows:

Ho:YAG - Urology

Endoscopic holmium laser resection of the prostate (HoLRP) with the VersaPulse Select Ho:YAG and Ho:YAG/Nd:YAG Surgical Lasers for treatment of benign prostatic hypertrophy (BPH).

Ho:YAG - Urology - Continued

Open and endoscopic urological surgery (ablation, vaporization, incision, excision and coagulation of soft tissue) including treatment of:

- bladder;

- urethral and ureteral tumors;

- condylomas;

- lesions of external genitalia;

- urethral and penile hemangioma;

- urethral strictures;

- bladder neck obstructions.

Urinary Lithotripsy including:

- endoscopic fragmentation of urinary calculi in the ureter or ureteropelvic junction;

- treatment of distal impacted fragments of steinstrasse when guide wires cannot be passed.

Nd:YAG - Urology

Urological surgery (ablation, vaporization, incision, excision and coagulation of soft tissue) including:

- removal of superficial bladder tumors;

- removal of invasive bladder carcinoma;

- removal of benign or malignant lesions of the external genitalia, including condylomas;

- treatment of urethral strictures;

- treatment of vascularities of the bladder wall;

- prostatectomy.

Ho:YAG - Arthroscopic Surgery / Arthroscopy

Arthroscopy (ablation, excision and coagulation of soft tissue) in various joints of the body, excluding the spine, including:

- meniscectomy;

- plica removal;

- ligament and tendon release;

- contouring and sculpting of articular surfaces;

- debridement of inflamed synovial tissue.

Discectomy including:

- percutaneous vaporization of the L4-5 and L5-S1 lumbar discs of the vertebral spine;

- open and arthroscopic spine procedures.

Nd:YAG - Orthopaedic Surgery

Arthroscopy (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:

Knee

- capsulectomy in the knee;

- chondroplasty in the knee;

- plica removal in the knee;

- lateral ligament release in the knee;

- meniscectomy in the knee;

- synovectomy in the knee;

- osteoarthritic lesion removal in the knee;

Shoulder

- coracoacromial release in the shoulder;

- debridement of scar tissue in the shoulder;

- adhesive capsule release in the shoulder;

- labral tear repair in the shoulder;

- synovectomy in the shoulder.

Discectomy:

- limited to open, percutaneous and arthroscopic vaporization of the L4-5 and L5-S1 lumbar discs of the vertebral spine in patients with:

- unilateral leg pain greater than back pain;

- paresthetic discomfort in a specific dermatomal distribution;

- positive straight leg raising test and/or positive bowstring sign;

- possible neurologic finding including wasting, weakness, sensory alteration and reflex alteration;

- no improvement after at least 6 weeks of conservative therapy;

- positive CT or MRI showing a subligamentous herniation at the location consistent with clinical findings.

Ho:YAG - General Surgery

Open, laparoscopic, and endoscopic general surgery (vaporization, ablation, incision, and coagulation of soft tissue) including:

- cholecystectomy;

- lysis of adhesions;

- appendectomy;

- removal of benign and malignant lesions;

- biopsy, pylorostenotomy, and removal of polyps of the sigmoid colon.

Nd:YAG - General Surgery

Open, laparoscopic, and endoscopic general surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:

- cholecystectomy;

- mastectomy;

- hepatectomy;

- pancreatectomy;

- splenectomy;

- hemorrhoidectomy;

- thyroidectomy;

- parathyroidectomy;

- herniorrhaphy;

- tonsillectomy;

- appendectomy;

- lymphadenectomy;

- partial nephrectomy;

- pilonidal cystectomy;

- resection of lipoma;

- pelvic adhesiolysis;

- removal of lesions;

- removal of polyps;

- removal of tumors;

- tumor biopsy;

- debridement of decubitus ulcers.

Ho:YAG - Endonasal Surgery

Endoscopic endonasal surgery (ablation, vaporization, incision, and coagulation of soft tissue and cartilage) including:

- partial turbinectomy;

- ethmoidectomy;

- polypectomy;

- maxillary antrostomy;

- frontal sinusotomy;

- sphenoidotomy.

Nd:YAG - Ear, Nose and Throat (ENT) Surgery

Endonasal surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:

- lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal tissues;

- tonsillectomy;

- adenoidectomy.

Ho:YAG - Gynecological Surgery

Open and laparoscopic gynecological surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue).

Nd:YAG - Gynecological Surgery

Gynecological surgery limited to:

- treatment of menorrhagia by the photocoagulation, vaporization, or ablation, of the endometrial lining of the uterus under direct hysteroscopic visualization;

- intra-uterine treatment of submucous fibroids, benign endometrial polyps, and uterine septum by incision, excision, ablation, and/or vessel coagulation;

- intra-abdominal treatment of endometriosis and/or peritoneal adhesions with laser contact tips;

- soft tissue excisional procedures such as excisional conization of the cervix.

Nd:YAG - Gastroenterologic Surgery

Gastroenterologic surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:

- partial removal of neoplastic tissue in the management of esophageal obstruction for symptomatic relief of dysphagia;

- gastrointestinal hemostasis including, varicies, esophagitis, esophageal ulcer, Mallory-Wiess tear, gastric ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers, and gastric erosions;

- gastrointestinal tissue ablation of benign and malignant neoplasm, hemorrhoids and polyps.

Nd:YAG - Thoracic and Pulmonary Surgery

Thoracic and pulmonary surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including treatment of:

- laryngeal lesions;

- airway obstructions including carcinoma;

- polyps and granulomas;

- palliation of obstructing carcinomas of the tracheobronchial tree.

Nd:YAG - Dermatology and Plastic Surgery

Dermatology and plastic surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:

- lesions of skin and subcutaneous tissue;

- telangiectasia;

- port wine lesions;

- spider veins;

- hemangiomas;

- plantar warts;

- periungual and subungual warts;

- removal of tattoos;

- debridement of decubitus ulcer;

- treatment of keloids.

Nd:YAG - Podiatry

Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:

- matrixectomy;

- plantar warts;

- neuromas;

- periungual and subungual warts;

- radical nail excision.

Nd:YAG - Neurosurgery

Neurosurgery limited to:

- hemostasis in neurosurgery procedures such as excision of brain lesions, spinal cord lesions, cranial nerves, peripheral nerves, and pituitary glands.

Nd:YAG - Ophthalmology

Ophthalmology limited to:

- post-vitrectomy photocoagulation.