SOLICITATION NOTICE
65 -- SYPGLASS BOSTON SCIENTIFIC
- Notice Date
- 9/8/2009
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- Department of Veterans Affairs;VA Boston Healthcare System;Contracting Officer (90C);940 Belmont Street;Brockton MA 02301
- ZIP Code
- 02301
- Solicitation Number
- VA-241-09-RQ-0356
- Response Due
- 9/14/2009
- Archive Date
- 11/13/2009
- Point of Contact
- Christine GormanContract Specialist
- E-Mail Address
-
Contract Specialist
(Christine.Gorman@va.gov)
- Small Business Set-Aside
- N/A
- Description
- Tuesday, September 8, 2009 The Department of Veterans, VA Boston Healthcare System, intends to sole source a requirement from Boston Scientific located in 100 Boston Scientific Way, Marlborough, MA 01752-1234 to provide SpyGlass Direct Visualization System. It is the Government's intention to solicit and negotiate only with this source. Please refer to the Sole Source Justification. This is not a solicitation; it is notice of intent to sole source a requirement. Inquires/information received after established deadline of Monday, September 14, 2009 1200 shall not be considered. The submission of any data for review shall not impede award of this contract as planned. The Government does not intend to pay for information solicited. This synopsis is issued pursuant to FAR 6.302-1. However, any firm that believes it can meet these requirements may give written notification to the Contracting Officer within five (5) calendar days from the date of publication of this synopsis. Supporting evidence must be furnished in sufficient detail, to demonstrate the ability to comply with the above requirements. This information can be faxed to Christine Gorman at 774-826-3347 or via e-mail to Christine.Gorman@va.gov. Responses will be evaluated; however, a determination by the Government not to compete the proposed procurement based upon responses to this notice is solely within the discretion of the Government. Post on FBO on Tuesday, September 8, 2009. Deadline on Monday, September 14, 2009 at 1200 EST. SCOPE OF WORK BRAND NEW SpyGlass Direct Visualization System from Boston Scientific Cholangioscopy: - for peroral direct visualization of the bile ducts and allow destruction of large common bile ducts and sampling of biliary strictures for diagnosis of cancer. A physician may choose to perform a cholangioscopy in the event that x-ray imaging from an ERCP is insufficient to make an adequate diagnosis, or therapeutic intervention requires direct visualization. The SpyGlass System is a single-operator system developed to overcome the challenges of traditional cholangioscopy systems and reduce the need for exploratory surgery. The SpyGlass System is designed to enable physicians to directly visualize the target site, obtain a diagnostic tissue sample with the disposable Biopsy Forceps, and deliver therapies such as laser and electrohydraulic lithotripsy (EHL). The only other cholangioscope in the market requires two endoscopists - one to operate the duodenoscope and a second to steer the cholangioscope and operate its working channel. It is very fragile due to its optical fibers, and breaks very easily leading to only a few uses (<10) per cholangioscope. So before the spyglass became available used peroral direct visualization of the bile ducts as a result of these technological difficulties. in the diagnosis of biliary disease. Cholangioscopy with the SpyGlass Direct Visualization System The SpyGlass Direct Visualization System is one of the latest advancements in intraductal visualization during a cholangioscopy. The SpyGlass System is a single-operator system that allows not only optical viewing, but also optically guided biopsies and has been shown to be compatible with electrohydraulic lithotripsy (EHL).* The SpyGlass System is designed to allow the physician the ability to directly visualize the site of interest - whether it be a stricture, stones or an area of concern - vs. traditional non-direct visualization techniques such as x-ray. Cholangioscopy with the SpyGlass System is performed by a single operator with the SpyScope Access and Delivery Catheter, which is positioned just below the operating channel of the duodenoscope. This allows the endoscopist to control both the tip deflection wheels of the duodenoscope and the knobs of the SpyScope Catheter with the same hand. The physician's other hand holds the duodenoscope, which is inserted into the patient's mouth and navigated through the anatomy to a position in front of the papilla where a sphincterotomy may be performed as necessary. At this point, the SpyGlass Probe is introduced into the SpyScope Access and Delivery Catheter. The bile duct is cannulated, and the SpyScope Catheter guides the SpyGlass Probe into the biliary tree. The SpyScope Catheter and SpyGlass Probe are maneuvered up to the desired area of interest within the duct for direct visualization. Additionally, selected ducts and branches of interest can be examined during repeated advancement and withdrawal of the system utilizing the four-way tip deflection. Two separate channels in the SpyScope Catheter allow for adequate irrigation to clear debris and aid in guiding both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the biliary system including the hepatic ducts. If necessary, the SpyBite Biopsy Forceps or an EHL probe*, guided by the SpyScope Catheter, is introduced. At this point, an optically-guided biopsy can be taken or stones may be fragmented. The SpyGlass Direct Visualization System is an integrated product platform that combines capital components and consumable devices and is designed to provide a direct intraluminal view of the biliary duct system and direct therapeutic devices. The SpyGlass Direct Visualization System is the latest advancement in intraductal visualization during a cholangioscopy. The SpyGlass System is the first single operator, intraductal system that allows for not only optical viewing, but also optically-guided biopsies and has been shown to be compatible with electrohydraulic lithotripsy (EHL) and holmium laser to fragment stones.* The SpyGlass System is designed to allow the physician the ability to directly see the site of interest, whether it be a stricture, stones or other area of concern, vs. traditional visualization techniques such as x-ray. The SpyGlass System consumable devices include: 1-SpyGlass Fiber Optic Probe This 6,000 pixel fiber optic probe enters the biliary anatomy through the SpyScope Access and Delivery Catheter. It is designed to acquire and transmit endoscopic images and conduct light into the biliary anatomy. Multiple use device that may be reprocessed after each use 2-SpyScope Access & Delivery Catheter The SpyScope Access & Delivery Catheter is a single-use, single-operator controlled, 10 Fr diameter, 230 cm length device designed to provide a pathway into the biliary anatomy for diagnostic and therapeutic devices. "Four lumen catheter includes: "One optic channel "One 1.2 mm accessory channel "Two independent irrigation channels "Tip of catheter has 4-way steering capabilities to help with navigation and access into all 4 biliary quadrants 3-SpyBite Biopsy Forceps Using the SpyBite Biopsy Forceps with the SpyGlass Direct Visualization System is designed to allow the physician to directly see the area of interest to take targeted, optically-guided biopsies. "1.2 mm minimum working channel required "286 cm working length "Jaw designed with central spike to aid in securing small tissue samples "Single use device EHL Compatible The SpyGlass System has been shown to be compatible with the Northgate 1.9Fr Biliary Probe and the Northgate Autolith Intracorporeal Electrohydraulic Lithotripsy iEHL Generator.* Laser Compatible The SpyGlass System has been shown to be compatible with the Lumenis SlimLine 365 Micron Laser Probe (M0068408420) and the Lumenis VersaPulse PowerSuite 20 Watt Holmium Laser Generator (M0068408220).*** The SpyGlass System capital components include: "Component Cart and Three-Joint Arm "Lightsource and Cable - 300 watt high intensity white light "Camera and Camera Head - Auto shutter camera with 1?4" CCD color image sensor "Ocular - optical coupler that interfaces with the Probe and Camera Head "Isolation Transformer "Power Cable Pack "Irrigation Pump "Sony Monitor JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION 1. Identification of the agency and the contracting activity. Medical Service/Gastroenterology Trans #523-09-4-7821-0092 *2. Nature and/or description of the action being approved. Sole Source procurement for Medical/Surgical supplies from Boston Scientific 100 Boston Scientific Way, Marlborough, MA 01752-1234 *3. Description of the supplies or services required to meet the agency's needs (including the estimated value). Medical/Surgical supplies/equipment to include Spy Glass Direct Visualization System from Boston Scientific 4. Identification of the statutory authority permitting other than full and open competition. FAR 6.302-1, USC 253(c)(1) Only One Responsible Source, *5. Demonstration that the proposed contractor's unique qualifi cations or the nature of the acquisition requires use of the authority sited. The SpyGlass System is a single-operator system developed to overcome the challenges of traditional cholangioscopy systems and reduce the need for exploratory surgery. The SpyGlass System is designed to enable physicians to directly visualize the target site, obtain a diagnostic tissue sample with the disposable Biopsy Forceps, and deliver therapies such as laser and electro-hydraulic lithotripsy (EHL). Cholangioscopy: - for peroral direct visualization of the bile ducts and allow destruction of large common bile ducts and sampling of biliary strictures for diagnosis of cancer. A physician may choose to perform a cholangioscopy in the event that x-ray imaging from an ERCP is insufficient to make an adequate diagnosis, or therapeutic intervention requires direct visualization. *6. Description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a Commerce Business Daily notice was or will be published. N/A. 7. Determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable. The Contracting Officer determined that the anticipated cost to the Government is fair and reasonable. 8. Description of the market survey conducted (i.e., names, of firms and the date(s) the firms were contacted) and the results or a statement of the reasons a market urvey was not conducted. The only other cholangioscope in the market requires two endoscopists - one to operate the duodenoscope and a second to steer the cholangioscope and operate its working channel. It is very fragile due to its optical fibers, and breaks very easily leading to only a few uses (<10) per cholangioscope. *9. Any other facts supporting the use of other than full and open competition, such as an explanation why technical data packages, specifications, engineering descriptions, statements of work, or purchase descriptions suitable for full and open competition have not been developed or are not available. Before the spyglass became available we used peroral direct visualization of the bile ducts as a result of these technological difficulties were encountered in the diagnosis of biliary disease. 10. A listing of the sources, if any, that expressed, in writing, an interest in the acquisition. None. 11. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required. This contracting activity will continue to encourage full and open competition whenever possible. The Contracting Officer will work closely with the Service to look for the similar equipment in the Open Market.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/VA/BoVAMC/VAMCCO80220/VA-241-09-RQ-0356/listing.html)
- Record
- SN01945246-W 20090910/090909084223-dd1fe012fab98e353653ff04cc4bbaa4 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |