Future
Funding sources
- European trials are underway for the Evolut R type valve, a self-expanding Nitinol-framed superannular valve which represents a substantial advance.
- This will allow recapturing and repositioning of the valve during deployment, it better conforms to an irregular annulus, and provides a delivery system with a smaller sheath to reduce the profile needed to access the patient vessel.
Conferences to learn more
about the Aortic Stenosis
- Emergency Medicine An Evidence-Based Approach to Adult Care: March 17-21 in Sarasota, Fl.
- CME - Cardiology Update in Primary Care Medicine An Evidence-Based Approach: January 26 - 30, 2015, Hawaii
Area of Focus
Problem
CoreValve System
Advantage of CoreValve System
1. Different sizes
26 mm, 29 mm, and 31 mm
a smaller version called CoreValve Evolut, with 23 mm in diameter
By Guneet Bhogal and Ashleen Sandhu
2. U.S. patients require larger valve sizes in diameter than available in Sapien or Sapien XT
a. Why does it occur?
-Serious, life-threatening condition where aortic valve does not open or close properly
b. What are the medical implications?
-Lead to fainting, chest pain, irregular heart rhythms, or even heart failure
c. Who is affected by it?
-2-3% of the North-American population aged 65 years and older
d. How severe is the effect?
-Over half of the patients will die within two years
- Longer and higher quality of life
- Faster recovery
FDA Approval
- The Center for Devices and Radiological Health (CDRH)
- From the U.S. Pivotal trial data since 2010, FDA has recently declared that the CoreValve system has been reasonably safe and effective for those patients who cannot undergo open-heart surgery.
- Higher survival rate to live longer in a year at about 86%
- The CoreValve System provides patients a greater chance for a longer and higher quality of life, due to faster recovery from the procedure.
300,000 people worldwide have been diagnosed with severe aortic stenosis
Market Research
Standard Method
Patents Strategy
Open Heart, Surgical Valve Replacement:
e. In what setting does the problem occur?
- The valve costs about $30,000 per procedure
- Medicare typically doesn't provide extra reimbursement beyond what it pays for surgery.
- Expected revenue: $2 billion and $2.5 billion annually by 2020
- Industry revenue: The international revenue of $1.87 billion increased by 5 percent. Emerging market revenue of $513 million increased 13 percent and represented 12 percent of the total revenue.
- Structural Heart revenue, which is the segment that includes CoreValve sales, grew 4 percent to $281 million.
Larger potential orifice area when implanted in a degenerative surgical bioprosthesis.
CoreValve demonstrates the lowest rate of post-procedural gradients in the Global Valve-in-Valve Registry.
Motivation for technology
-CoreValve system: High risk patients for open-heart surgery
- Recovery time:
-CoreValve System: 24-48 hours after surgery
-Open-heart surgery: 2 months
-Overall cost:
-CoreValve: ranging from $30,000 -$40,0000
-Shorter time spent at the hospital
-Open-heart surgery: cheaper
-Longer time spent at the hospital
Short video on the technology
Competition
- Edwards Lifesciences Corporation: Sapien XT valve