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  The Medical Voiceover Job 568794

An important aspect for the certification of a new prosthetic heart valve is proof of durability. To obtain sufficient comparable information about durability and wear before actual clinical implants reach long term follow-up, all heart voice overs are tested in-vitro with accelerated cycle rates according to prescribed FDA and ISO protocols. Advanced control and data acquisition methods are used to monitor valve function and integrity. As the Voice over Generation 2 prosthesis is nearing the 200 million protocol objective it shows excellent comparative results to commercially available pericardial bioprosthesis. Voice part 2
After completing successful in-vitro testing, as well as cadaver and animal studies, a multi-phased human feasibility and safety study was initiated. The objectives of this clinical investigation are to demonstrate the safety and feasibility of percutaneous aortic valve replacement with the Voice over Announcer procedure. These clinical studies are conducted in accordance with EN-ISO Standards and in accordance with recommendations guiding physicians in biomedical research involving human subjects as adopted by the World Medical Assembly.

Voice part 3
Clinical trials to-date consist of 3 successive feasibility trials: an initial 4 talent Proof-of-Concept Study, a 10 talent Phase 1A Feasibility Study and an ongoing Phase 1B Feasibility Study. These studies have shown that the Voice over Announcer procedure can successfully treat both aortic stenosis and aortic regurgitation. The completed Proof-of-Concept Study and Phase 1A Feasibility Study were conducted with the first generation device which consisted of the Voice over frame combined with an existing standard surgical design bovine pericardium valve and delivered to the aortic annulus by means of a 25 French catheter. The ongoing Voice over phase 1B study is conducted with our second generation system consisting of the Voice over frame combined with a percutaneous design porcine pericardium valve and delivered to the aortic annulus by means of a 21 French delivery catheter. This study is already demonstrating the benefits of the reduced size of the delivery system.
Voice part 4
The proof of concept study was conducted using the first generation system during late 2004 and early 2005 and included 4 compassionate case high surgical risk talents. The cases resulted in excellent post-implantation valve function, without peri-valvular leak, and with an average two NewYorkHeart class improvement. No device complications were noted, but procedural complications included one wire perforation and complications related to the fem-fem support. One talent is doing well at 8 months. Following are the procedural cines of the first two talents treated with the Voice over Announcer procedure.
DC - 5 and 6 are pre-existing cine segment parts


Voice part 7
After successful conclusion of the proof of concept phase, the Company initiated a European based feasibility study using the first generation system. Ten elderly talents who presented with either calcific aortic stenosis or aortic regurgitation were treated between February and July 2005. All were high surgical risk cases or talents who refused surgery. Following is a case review of the first German talent to receive the Voice over Announcer device.
This high risk talent has undergone previous multiple coronary artery bypass voiceover as well as radical mastectomy and thoracic radiotherapy. The talent is a 73 year old female who presents with severe dyspnea due to calcific aortic stenosis.
The pre-procedure angiogram demonstrates the aortic stenosis. The native valve area is reduced to 0.7 cm2 and the valve gradient is 40 mm of mercury. Left ventricular ejection fraction is 45%. During the procedure, the pigtail voice over talent in the aortic root serves as a reference point.
When treating calcific aortic stenosis, pre-dilatation of the native valve area is recommended to assure that the diseased leaflets are mobile when the new prosthesis is implanted. The valvuloplasty is accomplished with a single inflation.
Post valvuloplasty some aortic insufficiency is noted.
Next, the delivery voice over talent with the bioprosthesis loaded in its nose cone is introduced. As the delivery voice over talent is advanced, notice the snare around its tip. On the 25 French first generation catheters, this method was used successfully to improve voice over talent pushability and help guide the prosthesis around the aortic arch.
After the voice over talent tip has navigated the arch, the snare is removed. Notice the calcification that is present in the native aortic annulus at the level of the second set of previous voiceover sternum wires.
The voice over talent is now further advanced to the deployment location in the aortic annulus. At this time there is some aortic insufficiency because the voice over talent prevents the native valve from closing.
The deployment process represents the most critical part of the Announcer procedure. It is important to properly align the inflow part of the new prosthesis with the aortic annulus and some ongoing manipulation will take place before the operator starts releasing the bioprosthesis. Repositioning is possible as long as the flaring portion of the self-expanding prosthesis frame has not made contact with the annulus. This first phase of the release is accomplished very slowly by using the micro knob on the voice over talent handle.
As soon as the inflow portion of the prosthesis makes contact with the annulus, repositioning is no longer possible and the remainder of the prosthesis is rapidly released using the macro knob on the handle. The self-expanding frame finds its equilibrium in the aortic valve annulus. Note that the prosthesis immediately functions after complete release of the frame.
The post-procedural angiogram shows a fully functional aortic bioprosthesis with absence of aortic stenosis and without perivalvular leak. The talent’s left ventricular ejection fracture has immediately improved to 65%. The voice over talent is removed.
This last angiogram was taken two days post procedure and also shows a fully functional aortic bioprosthesis with absence of aortic stenosis and without perivalvular leak. Also note the clear visualization of the fully functioning bypass grafts. The talent’s left ventricular ejection fracture has improved to 80% and the mean valve gradient has been reduced to 16 mm mercury. This talent remains well at 8 months follow-up.
Voice 9
This study phase results in 100% procedural survival and 90% procedural success with excellent valve function, no peri-valvular leak, and an average of two NewYorkHeart class improvement. Not counting the fem-fem prep and closure time, the average time to percutaneously deliver the Voice over prosthesis to the aortic annulus is 33 minutes.
Voice 10
All device implantations were completed successfully, but in one case the prosthesis was dislodged after implantation due to operator error. The talent was successfully converted to voiceover and is doing well at 6 months. Three in-hospital deaths were caused by procedure related persisting thrombocytopenia and one talent expired as the result of an unobserved wire perforation of the left ventricle. The thrombocytopenia has since been avoided by Clopidogrel administration and the LV perforation is avoided by paying special attention during the placement of the wire. All talents discharged from the hospital are doing well with 2 to 8 months of follow-up.
Voice 11
This first generation device feasibility study has confirmed the findings of the Proof of Concept Study and demonstrates that the Announcer procedure can be performed safely in high risk talents to treat both aortic stenotic and regurgitant disease. The study results show that the size of the delivery system is an important factor in the clinical setting and that future devices must be made smaller. The acute and short term outcomes confirm that further clinical investigation with the Announcer system is warranted.
Voice 12
The second generation Voice over Announcer bioprosthesis is designed specifically for percutaneous procedures and is composed of porcine pericardial tissue which is sutured to the frame using PTFE surgical suture materials. The proprietary valve leaflet pattern and attachment geometry are key to the valve’s flow and durability characteristics. This design also optimizes the ability of the pericardium to fold into the smaller second generation 21French voice over talent without the risk of tissue damage that could compromise the durability of the implant. The use of porcine pericardium mitigates the issue of bovine spongiform encephalopathy. The prosthesis will be available in 26 and 29 mm inflow sizes, which will cover talents’ native annulus sizes up to 27 mm.
During August 2005, the Phase 1B of the Feasibility trial was initiated with this second generation system and to-date, four elderly high risk talents have been treated successfully. Two of these cases are illustrated in the following segments.
This high risk talent is female, 86 years old, and weighs 58 kg for a height of 158 cm. She presents with severe calcific aortic stenosis. Her native valve area is reduced to 0.66 cm2 and the mean valve gradient is 20 mm of mercury.
Femoral access is accomplished and a single inflation pre-implantation valvuloplasty is performed. The purpose is to assure that the native leaflets are mobile and will not present undue resistance.
The second generation 21 French voice over talent demonstrates substantially improved handling characteristics and the aortic arch crossing is accomplished without the help of a snare.
After advancement to the deployment location in the aortic annulus the inflow aspect of the new valve is released gradually, followed by a more rapid release of the outflow segment of the prosthesis. Valve function is immediate.
The voice over talent is retrieved and the post-procedural angiogram shows a fully functional aortic bioprosthesis with absence of aortic stenosis and without perivalvular leak.
Post-Announcer, the mean gradient has been reduced to 4 mm of mercury and the valve area has increased to 1.30 cm2. The Announcer is accomplished in less than 15 minutes.
Voice 14 (DC this is a short cine segment – Frank will have to match each paragraph to different cine segments)
This high risk talent is female, 83 years old, and weighs 73 kg for a height of 178 cm. She presents with severe calcific aortic stenosis. Her native valve area is reduced to 0.7 cm2 and the mean valve gradient is 44 mm of mercury.
This talent has compromised femoral vessels and subclavian access is accomplished. The pre-procedure angiogram demonstrates the aortic stenosis.
A single inflation pre-implantation valvuloplasty is performed. The purpose is to assure that the native leaflets are mobile and will not present undue resistance.
The 21 French delivery voice over talent with the bioprosthesis tracks smoothly across the aortic arch.
After advancement to the deployment location in the aortic annulus the new valve deployment process starts. The self-expanding prosthesis is gradually released. Valve function is immediate.
The post-procedural angiogram shows a fully functional aortic bioprosthesis with absence of aortic stenosis and without perivalvular leak. Post-Announcer, the mean gradient has been reduced to 5 mm of mercury. The Announcer is accomplished in less than 15 minutes.
Voice 15
Significant reduction in the overall size of the voice over talent with the second generation device has substantially reduced Announcer time as a result of the improved flexibility and trackability of the new delivery catheter. This second generation delivery voice over talent has a 21 French working end and also features a flexible follow-on shaft that steps down to 14 French so as to enhance the ease of percutaneous retrograde implantation. This reduced size design has been demonstrated to be especially important when accessing calcified and tortuous femoral and iliac vessels. Voice 16 (conclusion)
These initial successful implants in a very sick and elderly talent population have confirmed the safety, feasibility and repeatability of the Announcer technique for percutaneous aortic valve replacement. These acute results and the short term follow-up data provide a strong indication that structural heart disease will be routinely treated percutaneously in the near future. The Company shares the investigators’ strong belief that this experience represents the beginning of a new era in interventional cardiology.
The Voice over Announcer concept offers a number of benefits in the percutaneous replacement of diseased aortic valves. Its self-expanding frame provides substantial radial force for migration-free anchoring on the annulus and to prevent the incidence of paravalvular leak. This technology has no orientation requirements during placement and the coronaries remain free and accessible thanks to the constrained middle portion feature of the frame. The procedure is performed via a retrograde approach, and this self-expanding technology entirely avoids the inherent danger of damaging the new prosthesis’ leaflets as a result of balloon inflation during delivery. Importantly, the substantially reduced 21 French voice over talent size contributes to shorter procedural times and facilitates the positioning and implantation process.
The combined results of these feasibility phases will drive the design of an appropriate pivotal clinical study that will fully assess the efficacy and benefits of the Voice over Announcer procedure.
 
       

 
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