Edwards Tiptoes into the Market

Edwards Lifesciences, a medical device manufacturer of trans-catheter heart valves, has traditionally been known for its innovative thinking and aggressive marketing. Edwards is set to receive FDA approval for Sapien, a trans-catheter aortic valve for patients with aortic valve disease. Sapien is the first aortic valve in the US market with Medtronic and several other medical device companies at least 1-2 years behind.

However, as these articles points out (1, 2), Edwards has decided not to aggressively enter the US market, the largest market for this product. Rather, Edwards is slowly onboarding key centers like Robert Wood Johnson. Conventional wisdom suggests that first-to-market players should capitalize on their early entry to the market but trying to capture as many customers as possible and trying to build loyalty early. So why then has Edwards chosen a conservative launch strategy for the US market?

Here are some potential reasons:

• The FDA has mandated a more careful roll out of Sapien.
• Assure early success of the device to convince skeptical physicians.
• Inadequate reimbursement
• Carefully select patients to reduce the risk of stroke, an adverse event associated with trans-catheter aortic valve implantations

The slower roll out will make patient access to TAVI more difficult in the US. However, the strategy may pay off in the long run as failed or improper implantations could lead to death and recalls. This would open the door for competitors like Medtronic to gain share.

All industries, but especially the medical device industry, have numerous examples of first-to-market players. Cordis, a J&J company, was first-to-market with stents but was forced to exit the market several years later due to heated competition.

Having worked on Medtronic’s trans-catheter pulmonary valve last summer, I will be eagerly watching the battle for the TAVI market.