Hi Eric: Take a look at the press release. Hard to quantify the market, but such market should be considerable. I am not a vascular surgeon, so I do not have a firm grasp of the subject.
As to GGNS...the answer is with the CEO. He must go, or the company must be bought. Too much past baggage with Mr. Elder. As I have said on that thread, I would love to be very wrong.
Keep in touch.
m1
Press Release Source: Spectranetics Corporation
Study Investigators Perform First Successful Peripheral Procedures With CLiRpath Extreme Excimer Laser Catheters Following April 29 510(k) Market Clearance
Thursday May 6, 5:23 pm ET
COLORADO SPRINGS, Colo., May 6 /PRNewswire-FirstCall/ -- Spectranetics Corporation (Nasdaq: SPNC - News) announced today that the first successful CLiRpath(TM) procedures using new Extreme® Excimer Laser Catheters recently cleared by the U.S. Food and Drug Administration were performed by Craig Walker, MD, Mohammed Khan, MD and David Allie, MD at Cardiovascular Institute of the South in Louisiana and by John R. Laird, MD at the Washington Hospital Center in Washington, DC. The physicians utilized the larger, 2.3 mm and 2.5 mm CLiRpath(TM) Catheters that were introduced into the U.S. market on Tuesday, May 4. Dr. Laird was Principal Investigator of the LACI (Laser Angioplasty for Critical Limb Ischemia) trial. Dr. Allie and Dr. Walker were principal investigators in the Louisiana LACI Case Series. Clinical data from a subset of patients enrolled in these trials were used to support the 510(k) market clearance.
Dr. Laird utilized a 2.3 mm CLiRpath(TM) Catheter to successfully recanalize a 30 cm occlusion in the superficial femoral artery in a patient with an ischemic ulcer. After successful laser atherectomy, balloon angioplasty was performed without the need for a stent. Dr. Laird commented, "As an investigator in the LACI trials, I am gratified that we have obtained market clearance for these catheters. The data used to support the submission included critical limb ischemia patients who were poor surgical candidates and who could not be treated with standard balloon angioplasty because a wire could not cross the occlusion. Despite the severity of the disease, we achieved a limb salvage rate of 95% in survivors in a patient group that historically would have been almost assured of an amputation."
Dr. Walker, Dr. Allie and Dr. Khan performed CLiRpath(TM) procedures at Opelouses General Hospital in Opelouses, Lousiana and Southwest Medical Center in Lafayette, Lousiana. They included two successful limb salvage procedures using the 2.5 mm CLiRpath Catheters to recanalize the superficial femoral artery (SFA), popliteal artery and the proximal peroneal artery. Dr. Walker commented, "The bigger laser catheter made a significant impact in the vessels we treated, especially where there was predominantly thrombus. In one case where we treated an occluded SFA, we accomplished a stand-alone laser result with no need for ballooning or stenting." He added, "We have been using the excimer laser in our practice to treat critical limb ischemia with limb salvage rates in excess of 90%. The larger catheters are important additions that allow us to more efficiently treat larger vessels. The new catheters worked very well and we are looking forward to using more of them."
"We are extremely pleased with the initial feedback following the CLiRpath product introduction on Tuesday, May 4," said John G. Schulte, Spectranetics' president and chief executive officer. "We were able to begin shipping within one week of FDA clearance and initial orders have been encouraging."
CLiRpath(TM) Excimer Laser Catheters are indicated for use in the endovascular treatment of symptomatic infrainguinal lower extremity vascular disease where total obstructions cannot be crossed with standard guide wires.
About Spectranetics
Spectranetics is a medical device company that develops, manufactures and markets single-use medical devices used in minimally invasive surgical procedures within the cardiovascular system in conjunction with its proprietary excimer laser system. The Company's CVX-300® excimer laser is the only system approved by the FDA for multiple cardiovascular procedures, including coronary atherectomy, and the removal of problematic pacemaker and defibrillator leads. In April 2004, Spectranetics received 510(k) clearance from the FDA for its CliRpath® Excimer Laser Catheters, which are indicated for use in the endovascular treatment of symptomatic infrainguinal lower extremity vascular disease where total obstructions are not crossable with a guide wire. Nearly all of Spectranetics' FDA-approved and investigational applications have received Communautes Europeennes (CE) mark registration for marketing within Europe.
Safe Harbor Statement
This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties may include increasing price and product competition, increased pressure on expense levels resulting from expanded marketing and clinical activities, uncertain success of the Company's strategic direction, dependence on new product development, intellectual property claims of third parties, availability of inventory from suppliers, the receipt of FDA approval to market new products or applications and the timeliness of any approvals, the potential size of market opportunities associated with new products, market acceptance of new products or applications, product defects, price volatility due to the initiation or cessation of coverage, or changes in ratings, by securities analysts. For a further list and description of such risks and uncertainties that could cause the actual results, performance or achievements of the Company to be materially different from any anticipated results, performance or achievements, please see the Company's previously filed SEC reports. Spectranetics disclaims any intention or obligation to update or revise any financial projections or forward-looking statements, whether as a result of new information, future events or otherwise.
Spectranetics and CVX-300 are registered trademarks of The Spectranetics Corporation.
For further information, please contact: John Schulte, Chief Executive Officer, or Guy Childs, Chief Financial Officer, both of Spectranetics Corporation, +1-719-633-8333; or investors, Bruce Voss or Ina McGuinness, both of Lippert/Heilshorn & Associates, Inc., +1-310-691-7100, for Spectranetics Corporation. |
