MITRAL VALVE REPAIR BACKGROUND

Transcription

1 MITRAL VALVE REPAIR BACKGROUND THE PROBLEM Heart valves are held in place with string-like tendons that can stretch or break, keeping the heart from pumping properly. If left untreated, this can lead to pulmonary hypertension, arrhythmias and congestive heart failure. Mitral Regurgitation is the most common type of heart valve disease, with an annual incidence of 250,000 newly diagnosed patients in the U.S. Approximately only 50,000 undergo surgery each year because the traditional method would be too invasive. TRADITIONAL METHOD OF REPAIR Open heart procedure (sternotomy) Patient s heart is stopped and they are placed on bypass Surgeon manually applies sutures to mitral valve Patient is taken off bypass to ensure the repair was successful. If it was not, the patient is placed back on bypass and the suture is re-applied. Normal Mitral Valve Compared with Prolapsed Leaflet and Ruptured Chordae NeoChord DS1000 Supporting Document 1

2 CLINICAL PROOF OF CONCEPT TECHNOLOGY SOURCE Dr. Giovanni Speziali, MD & Dr. Richard Daly, MD Mayo Clinic, Rochester, MN. Recieved Mayo Clinic Internal Award for Excellence NEOCHORD, INC. NeoChord, Inc. was created to develop the Mayo Clinic concept and we were engaged to design and engineer a commercially viable product. Proof of Concept Prototype TECHNICAL CHALLENGES Expensive to produce & not reusable Stainless steel left shadowing when viewed through imaging equipment Needed to have the capability to deploy multiple sutures for each patient Required multiple hands for operation Required multiple steps and complex movements Uncomfortable to use and didn t provide surgeon tactile feedback Required a hookup to an expensive non-universal external display NeoChord DS1000 Supporting Document 2

3 DESIGNING FOR COST SAVINGS MATERIALS SELECTION The stainless steel tip on the proof of concept prototype stainless steel tip design left a shadow in the echocardiogram during surgery. Plastics cause little interference in imaging and provide better tactile feedback to the surgeon. It was a significant challenge to engineer the complex mechanical movements in such a small footprint utilizing plastics. The injection molded parts lowered the per unit cost of the device, making it a disposable application. DISPOSABLE CARTRIDGE The challenge was to create a disposable device that could deploy multiple sutures on one patient. The proof of concept prototype would have required one instrument per suture used for edge-to-edge repair, one for each suture. An exchangeable cartridge allowed the surgeon to reload the DS1000 in the operating room within the sterile field. The disposable cartridges are pre-loaded with commercially available eptfe sutures indicated for artificial chords. Parts Explosion Rendering Pre-Loaded Disposable Cartridge NeoChord DS1000 Supporting Document 3

4 PERFORMANCE & USABILITY TIP DESIGN & SUTURE DEPLOYMENT The original tip design required movement in two planes to turn the needle before grabbing the suture and pulling it through. A canted tip design enabled the surgeon to slide the needle forward, pull it back, and grab the suture with a simplified motion in a single plane. Delivering a Suture Diagram Early Method: Deploying a Suture Refined Method: Deploying a Suture Slide Needle Up Turn Needle to Exact Angle Slide Needle Back to Hook and Pull Suture Slide Needle Up Slide Needle Back to Hook and Pull Suture Photos from Prototype Testing HANDLE ERGONOMICS STUDY Researchers conducted interviews with surgeons at the Mayo Clinic to gain insight on clinical workflow and surgeon behavior. These insights led to prototypes that were iteratively tested through ergonomic and form studies. Tactile feedback or feel was an important consideration for future surgeon adoption and success. Handle design variations were tested to ensure that the device was comfortable and intuitive to use while delivering the feel surgeons demanded. NeoChord DS1000 Supporting Document 4

5 ENHANCING EFFICIENCY LEAFLET CAPTURE VERIFICATION (LCV) MONITOR The original prototype required an external light source and external hookup to a non-universal display. This hookup would have required a capital investment for any surgery center wanting to adopt the NeoChord procedure. We created a low-cost disposable monitor that came tethered to the device. The LCV Monitor is a universal solution that is shipped within the sterile packaging. It is small, simple to read, and can be easily placed in the surgeon s line of vision to optimize efficiency in the operating room. RED LIGHTS Indicate the device tip is in a blood pool and must be repositioned to achieve leaflet capture. RED & WHITE LIGHTS Indicate partial leaflet capture. WHITE LIGHTS Indicate the clamp on the tip is in ideal positioning for leaflet capture and the surgeon may proceed to deploy the suture. LVC Monitor Indicator Diagram NeoChord DS1000 Supporting Document 5

6 STAKEHOLDER BENEFITS OF NEOCHORD DS1000 SURGEON PATIENT COMPANY HEALTH CARE SYSTEM Reduces time, risk, liability, and complications compared to traditional highly invasive procedures. Simple, ergonomic design to enhance usability and performance by enabling a surgeon to easily grasp the flailing leaflet with one hand and deploy a suture with the other hand. Immediate confirmation that the regurgitation is reduced allows the surgeon to validate their results. Provides a minimally invasive solution that doesn t require a sternotomy and heart bypass leading to a shorter hospital stay, faster recovery, less scaring, and lower risk of infection. Treats a wider range of patients for whom surgery would either be too invasive or too dangerous based on the severity of the patient s symptoms. Improved long-term survival with better heart performance, more energy, and lower risk of long-term heart conditions. Opens a new market segment with a low-cost disposable instrument. Product ships sterile and selfcontained with the fiber optic LCV monitor and pre-loaded industry standard sutures. Plastic injection molding saves manufacturing time and expense compared to precision machining associated with stainless steel. Strong clinical outcomes are projecting strong potential for sales and profitability. Provides a solution for the 80% of patients who are not treating mitral regurgitation due to the highly invasive nature of the traditional procedure. Eliminates the watchful waiting period for asymptomatic patients as their condition progresses to something more severe. Improves patient throughput with decreased surgery time and shorter recovery periods. Decreases liability compared to the highly invasive bypass procedures. NeoChord DS1000 Supporting Document 6