Edwards considers adding mitral repair to replacement


Is the CardiAQ valve not enough? Edwards Lifesciences, formerly known for its fondness for in-house R&D, has followed its out-of-character purchase of the transcatheter mitral valve company CardiAQ by taking an option on another, Baltimore-based start-up Harpoon Medical.

Harpoon’s device, also called Harpoon, is not like CardiAQ’s in that it is intended to repair, rather than replace, a damaged mitral valve. Edwards is taking a step towards the space occupied by Abbott Labs’ MitraClip, the only FDA-approved mitral repair device.

Details about the deal itself are scant, with Edwards simply saying it is making a structured investment in Harpoon including an upfront investment and an exclusive option to acquire the company.

Harpoon’s repair device is still in feasibility trials. At this year’s Transcatheter Cardiovascular Therapeutics meeting the company reported a 100% success rate in 10 patients with severe degenerative mitral valve disease, with reduction of mitral regurgitation to mild or less seen in all patients. No deaths, strokes or renal failure were seen, and conversion to open heart surgery and blood transfusions were also avoided.

The cash from Edwards will be added to the $1.4m of convertible debt – part of a $2m bridge financing – Harpoon raised in September. At the time, the company said that cash would go towards the feasibility study and would also enable it to start a larger clinical trial to support CE mark approval. This is to start enrolling patients by the end of this year.


Abbott's MitraClip is currently the only minimally-invasive mitral repair device available in the US, but at least two others are CE marked in Europe: Cardiac Dimension's Carillon device and Valtech Cardio’s Cardioband. Valtech was bought by HeartWare during the spate of purchases of mitral tech specialists in the summer (Mitralmania continues as HeartWare buys Valtech, September 3, 2015).

The market seems likely to grow. MitraClip is set to bring in $200m in sales this year, according to EvaluateMedTech’s consensus forecasts, rising to nearly double that in 2020.

So it is easy to see why Edwards has decided to cover itself on the repair side as well as replacement. It is more interesting that it has done so via an acquisition and an option for a second, rather than following its traditional – and extraordinarily successful – path of developing technologies itself.

Yesterday the company said it expects its transcatheter heart valve sales to increase by between 10% and 18%, hitting $1.2-1.4bn in 2016. Its transcatheter aortic valves alone will bring it $5bn in 2021, Edwards said, helped by expanded indications for what has arguably been the most successful medical innovation of the last decade.

It seems unlikely that the market for non-surgical devices to treat mitral valve disease will grow as rapidly or reach the same heights. But Edwards is understandably keen to stake out a space here, even if it means buying in technologies. It will not be a surprise if its rivals start to buy in mitral repair devices too.

To contact the writer of this story email Elizabeth Cairns in London at elizabethc@epvantage.com or follow @LizEPVantage on Twitter

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