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MID Hopes to Take TAVR to the Next Level


Posted in Cardiovascular by Brian Buntz on December 17, 2012

Although the company was founded in 2010, the genesis of Micro Interventional Devices (MID; Bethlehem, PA) is roughly thirty years in the making, says the firm’s founder and CEO Michael Whitman. The firm has developed a self-sealing cardiac access and closure device that can facilitate procedures such as transcatheter aortic valve replacement (TAVR). “Tissue healing and wound healing is where I spent most of my career,” Whitman says. In the past three decades, he has also learned much about percutaneous coronary procedures; while working at Johnson & Johnson in the 1990s, Whitman was involved in the launch of the coronary stent. He later went on to found Power Medical Interventions, a pioneer of computer-assisted surgical devices that went public in 2007 and was acquired by Covidien in 2009. 

Highlights

  • October 2012: Initiates “first-in-man” trial of Sutureless Transapical Access and Closure 
  • August 2012: Secures $100,000 Funding from Ben Franklin Technology Partners. 
  • May 2012: Secures bridge financing to advance clinical development of Permaseal. 
  • December 2011: Positive data announced from Permaseal animal study. 
  • April 2011: Acquired Endovalve Inc.

 Focus Going Forward

  • Complete STASIS study. 
  • Receive CE Mark clearance and commence commercialization in Europe. 

Challenges of Current TAVR Technologies

  • Lack of control and accuracy in delivery for the surgeon.
  • Steep learning curve for the surgeon to perfect the technique.
  • Difficult to achieve consistent outcomes. 
  • Technique and tissue quality vary from patient to patient.
  • Moderate to severe paravalvular leaks.
  • Time consuming.

Leadership

  • Michael P. Whitman, president and CEO
  • Willard Hennemann, PhD, chief science officer
  • Michael Hansberry, director of operations
  • Pete Datcuk, director of product development

Contact

Power Medical Interventions was founded to faciliate minimally invasive procedures. Similarly, MID could follow a similar path, by creating products that improve percutaneous and minimally invasive heart repair procedures like TAVR.

“When you look at TAVR, it is almost prima facie obvious that a catheter-based technology is going to superior to an invasive surgical procedure where your chest is cracked.” As TAVR technology becomes more widely adopted and the procedure evolves, the need for ancillary tools to support the core technology becomes a necessity. It is possible to anticipate what that toolbox will be before demand for it exists, Whitman says. “It takes years and years of experience or time in the OR to be able to anticipate those things,” he acknowledges.

The idea for the company was hatched following a conversation Whitman had with an executive at a large device company, which highlighted the need for a supplemental TAVR technology to simplify closing the apex during the transapical approach of the procedure.

“For TAVR, the transapical approach when done with a reproducible access and closure device may be superior to transfemoral approach. This is based on data that has been compiled in the European experience,” Whitmans says.

In October 2012, MID announced that a human patient had been treated using the firm’s Permaseal self-sealing, cardiac access and closure technology. The patient was the first to enroll in a European clinical trial known as STASIS, which stands for “Sutureless Transapical Access and Closure Study.” The study will investigate the use of the technology in 40 patients receiving Edwards Lifesciences’ Sapien XT via transapical delivery. The company anticipates that top-line data from the study will be available in 2013.

MID also has plans to commercialize the first fully percutaneous mitral valve replacement device. Known as the Endovalve, the technology is covered by four U.S. patents. The Endovalve also will make use of the company’s Permaseal platform, which will enable it to be delivered via the transapical approach.

In the long term, the company plans to expand its focus, and will introduce a portfolio of products to treat structural heart disease. Like the introduction of TAVR itself, it is likely that the company’s first products will be commercialized in Europe before hitting the domestic market.

 

“Creating a commercially viable product that can be manufactured in a cost effective way that maintains regulatory compliance is a byproduct of experience and collaboration.”

—Michael Whitman, president and CEO 

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz.


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