Minimally invasive cardiac surgery closure device to cut recovery times

  As the trend toward minimally invasive cardiac surgery grows, a cardiac medical device startup […]

 

As the trend toward minimally invasive cardiac surgery grows, a cardiac medical device startup has developed a sutureless closure device to facilitate transcatheter aortic valve implantation that could cut recovery times and reduce hospital costs.

In an interview with MedCity News, Micro Interventional Devices CEO Michael Whitman said he sees a niche in the market for a specific access closure device.

Micro Interventional Devices’ lead device, Permaseal ,uses a sutureless technology to repair the access point of the procedure and closes using a combination of soft tissue anchors and biocompatible elastomers that produce a web structure around the myocardial access site, according to a company statement. The device is applied to the myocardium before the procedure and provides hemostatic access to the left ventricle during minimally invasive cardiac procedures. After the procedure is done and the guidewire is extracted, the webbing from the device constricts around the opening in the heart and closes up the wound. The company is also seeking to use the device for transcatheter mitral valve replacement and mitral valve repair.

When it first evaluated the TAVI market before the Bethlehem, Pennsylvania company’s launch in 2010, it was valued at $100 million to $150 million. That is expected to grow to $2 billion by 2015, according to Whitman, who cited data from Wells Fargo.

The company got funding from Life Sciences Greenhouse of Central Pennsylvania earlier this year, who contributed to its $500,000 bridge financing. Other investors include Battelle Ventures, New Hope Ventures and Ben Franklin Technology Partners of Northeastern Pennsylvania. It is commencing a series B financing round in September that will seek investments totaling $5 million to $8 million to get its device through CE mark approval, a target it is setting out to reach by the end of the fourth quarter, and commercialization in Europe.

The CE-Mark STASIS study will evaluate the safety and performance of Permaseal for left ventricular transapical access and closure, with procedure time serving as a secondary endpoint, according to the company.

One benefit of developing a device used at the beginning and end of a surgical procedure is it reduces the amount of a time it would take to prove a product’s efficacy and safety as compared with, say, an artificial valve or another device that would take years to evaluate. The upcoming 40-person STASIS trial in Europe scheduled for the third quarter this year is expected to have top-line results in the fourth quarter.

Unlike bypass surgery, the heart is beating when TAVI procedures are performed. In what Whitman describes as disruptive technology, the device is intended to reduce blood loss and the amount of time the patient spends on the operating table, improving their outcome.

Whitman has worked in the medical device space for several years for companies such as Johnson & Johnson (NYSE:JNJ) and Synthes, acquired by J&J. He also started a robotic surgical stapling company called Power Medical Interventions, which Covidien acquired in 2009.

It looks admirably at the exit by medical device maker Kensey Nash, which produces a vascular closure device, that resulted in a $360 million acquisition by Royal DSM last week and highlights the deal as an example of the kind of opportunities available for startups in this market.

“At J&J, we passed on it because we thought it was a relatively small opportunity, and now it’s the standard of care.”

 

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