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Biotech / Medical : Future Medical Device Companies -- Ignore unavailable to you. Want to Upgrade?


To: dr.praveen who wrote (17)9/17/2006 6:50:51 PM
From: keokalani'nui  Read Replies (1) | Respond to of 136
 
An existing medical device co, this could be an important product in a few years. Investors today have to take taxus stent risk however.

Positive Preclinical Data on Vascular Wrap(TM) Presented at Vascular Conference
Sunday September 17, 2:00 pm ET

New Technology Has Potential to Improve Quality of Life for Hemodialysis Patients
VANCOUVER, Sept. 17 /CNW/ - Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP), a global specialty pharmaceutical and medical device company, today announced positive preclinical data related to its Vascular Wrap(TM) paclitaxel-eluting mesh and Lifespan(R) graft technology platform at The Western Vascular Society 2006 Annual Meeting in La Jolla, California.

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The purpose of this preclinical study was to evaluate the effect of the Vascular Wrap(TM) bioabsorbable mesh containing paclitaxel on inhibiting neointimal hyperplasia in an animal model of dialysis access failure. In this study, neointimal hyperplasia was reduced by a minimum of 87.6% in animals who received a paclitaxel-eluting mesh compared with animals who received no mesh.

snip

Earlier in August, Angiotech announced the intent to launch a clinical trial in the United Kingdom to determine if hemodialysis patients who receive the Vascular Wrap paclitaxel-eluting mesh/Lifespan graft combination product experience fewer graft failures than those patients that receive the graft alone. Angiotech expects to enrol the first patient in the UK-based clinical trial this fall. The company also intends to conduct a similar trial in the U.S. Both trials are expected to be about 24 months in duration, with enrolment taking approximately one year. The goal of the studies is to provide Angiotech with sufficient data to submit to regulatory authorities for the approval to market the products in the United States and Europe.



To: dr.praveen who wrote (17)9/27/2006 9:17:26 AM
From: dr.praveen  Respond to of 136
 
Merck and FoxHollow Technologies Expand Scope of Worldwide Strategic Research Collaboration
Wednesday September 27, 9:00 am ET
Merck Commits More Than $100M in Funding and Acquires Stake in FoxHollow

REDWOOD CITY, Calif., and WHITEHOUSE STATION, N.J., Sept. 27 /PRNewswire-FirstCall/ -- FoxHollow Technologies, Inc. and Merck & Co., Inc., today announced that they will expand the scope of their existing strategic collaboration for atherosclerotic plaque analysis and that Merck will acquire a stake in FoxHollow with the purchase of $95 million in common stock, subject to customary closing conditions and clearance under the Hart-Scott-Rodino Anti-Trust Improvements Act.

Under the terms of the expanded collaboration agreement, Merck will pay $40 million to FoxHollow over four years in exchange for FoxHollow's agreement to collaborate exclusively with Merck in specified disease areas. If Merck extends the collaboration program beyond this period, to continue the exclusive collaboration arrangement, Merck would pay $10 million per year, which may be offset by potential royalty and milestone obligations.

Merck will also provide a minimum of $60 million in funding to FoxHollow over the first three years of the four year collaboration program term, for research activities to be conducted by Fox Hollow under Merck's direction, including removal of atherosclerotic plaque from patient arteries for analysis, conduct of clinical trials and drug profiling by Merck. FoxHollow will receive milestone payments on successful development of drug products or diagnostic tests utilizing results from the collaboration, as well as royalties.

In addition, Merck will acquire newly-issued shares of FoxHollow common stock at $29.629 per share, representing approximately an eleven percent stake in the company. FoxHollow will appoint a Merck representative to the FoxHollow Board of Directors, increasing the size of the board to six members, and receive certain protective provisions.

Novel Collaboration Enlarged

It was in September 2005 that FoxHollow and Merck announced the first pharmaceutical-medical device partnership aimed at identifying cardiovascular biomarkers for use as diagnostics and as tools for drug development.

The expanded collaboration remains focused on the analysis of atherosclerotic plaque collected from patients treated with FoxHollow's SilverHawk(TM) Plaque Excision System. The scope and magnitude of these studies have substantially increased and other disease areas have now been added. Merck is using these analyses of human atherosclerotic plaque as a means of identifying novel targets to treat atherosclerosis and biomarkers to develop therapies that are in Merck's pipeline or have been licensed from other partners.

"For the first time in any pharmaceutical company's history, we have the ability to capture and evaluate atherosclerotic plaque from thousands of patients," said Peter S. Kim, Ph.D., president of Merck Research Laboratories. "Our first year of collaboration with FoxHollow has given us novel insights into cardiovascular disease, and we're very pleased to enlarge our relationship today to continue this focus on cardiovascular disease while including other important disease areas as well."

The expanded collaboration will also enable FoxHollow to use human plaque analysis to enhance the capabilities of its NightHawk(TM) intravascular plaque imaging system, and accelerate its anti-restenosis drug therapy program.

"Removing and analyzing plaque from patients unlocks a tremendous amount of valuable information that informs research moving forward," said John Simpson, Ph.D., M.D., CEO of FoxHollow. "Merck's expertise in cardiovascular medicine makes it uniquely suited to partner with FoxHollow in this work. We are proud to be working together and welcome Merck's input on our Board of Directors."

"We hope our collaboration will lead to the development of novel, individualized cardiovascular therapies," noted Richard C. Pasternak, M.D., vice president of Cardiovascular Research, Merck Research Laboratories, who has worked closely with FoxHollow in the past year. "We look forward to the expansion of what has been a most productive partnership with FoxHollow."

His words were echoed by Duke Rohlen, FoxHollow's president of Strategic Operations. "We are passionately committed to improving patient care through the development of innovative and effective treatments," Rohlen added. "An essential part of that commitment is partnering our device expertise with Merck, an innovative leader in cardiovascular pharmaceutical research and development."



To: dr.praveen who wrote (17)10/3/2006 11:08:31 PM
From: dr.praveen  Respond to of 136
 
TCT2006 alcohol septal ablation

author/presenter is John Buergler

Three Month Results Using a Novel Magnetic Navigation System to Perform Alcohol Septal Ablation

Background: Some patients with hypertrophic obstructive cardiomyopathy (HOCM) develop medically-refractory angina and heart failure that can be debilitating. Alcohol septal ablation (ASA) has been used to improve these symptoms, although septal perforator cannulation can be challenging given its takeoff from the LAD and/or small size. A new device that assists with ASA is magnetic assistance ((Stereotaxis, Inc. St. Louis, MO), in which magnetic fields are used to guide the wire tip to the desired location. However, little clinical and echo follow-up data exist in patients who have ASA using MAI. We assessed improvements in symptoms, exercise capacity and echo parameters symptoms at 3 months.

Methods: From October 2004 through December 2005, twenty-nine consecutive HOCM patients with medically-refractory symptoms of angina underwent ASA using magnetic assistance with the Niobe System (Stereotaxis, Inc. St. Louis, MO). These patients were then followed for 3 months to assess changes in CHF, angina, exercise capacity (METS and MV02), echo gradient and septal thickness compared with baseline.

Results: NYHA class improved from 3.2 ± 0.4 to 1.5 ± 0.9 (p<0.001). Angina class improved from 1.9 ± 1.0 to 1.2 ± 0.5 (p<0.01). The pressure gradient was reduced from 70 ± 33 to 32 ± 32 mm Hg (p<0.001). The septal thickness was reduced from 1.9 ± 0.3 to 1.4 ± 0.4 mm (p<0.001). Modified Bruce protocol treadmill time improved from 7.2 ± 4.1 to 9.8 ± 4.3 minutes (p<0.001). MV02 improved from 14.6 ± 4.0 to 17.8 ± 2.7 ml/kg/min (p<0.001).

Conclusions: ASA with MAI provides dramatic reductions in symptoms, exercise tolerance, echo gradient and septal thickness at 3 months. MAI has the potential to increase the efficacy of ASA in patients with HOCM. Additional studies are warranted to prove this hypothesis.

TCT2006 robotic epicardial ablation

author is Takeyoshi Ota.

Epicardial Atrial Ablation Using A Novel Highly Articulated Robotic Probe Through A Subxiphoid Approach.

Background: Minimally invasive epicardial atrial ablation to cure atrial fibrillation using a percutaneous subxiphoid approach is currently hampered by the lack of dedicated technology for intrapericardial navigation around the beating heart. We have developed second prototype of a novel highly articulated robotic probe and performed experiments in a porcine preparation.

Methods: The highly articulated robotic probe consists of the feeder and the rod looks like a “snake”. The “snake” robot is aimed to facilitate to access to intraepicardial space with a small skin incision and deliver therapeutic instruments through the working port of the robot.

In 5 large healthy pigs, the robotic catheter was introduced inside the pericardial space using a subxiphoid percutaneous approach in a closed chest environment and tested navigation to the left atrial appendage through some pathways, while the test was observed using a thoracoscope inserted from the left intercostal space as visualization. The operator actively controlled the path of the catheter using a master manipulator. After the robot with a radiofrequency ablation catheter was guided around the left atrium, epicardial ablation around the pulmonary veins was performed.

Results: Access to the pericardial space and progression around the left atrium was successful in all cases without adverse events. Epicardial ablation was successfully accomplished in all cases. Transmural ablation was confirmed by histopathology of the left atrium.

Conclusions: The second prototype of the snake robot could advance through the pericardial space without adverse events on the closed chest beating heart. We successfully performed epicardial left atrial radiofrequency ablation through the subxiphoid approach.