TAMPA — A Tampa company of which Dr. Kiran C. Patel is chairman has moved closer to winning federal approval of cardiac devices coated with a substance that reduces the risk of heart blockages.
The Food and Drug Administration this week granted Concept Medical Inc. “breakthrough device designation’’ for MagicTouch, balloon catheters coated with Sirolimus for the treatment of in-stent restenosis. The designation speeds up the review process while still adhering to federal standards.
In-stent restenosis is the gradual re-narrowing of a coronary artery that has been opened with a stent. Concept Medical and its manufacturing subsidiary in India have developed new technologies in which stents and cardiac balloons used to open blocked arteries are coated with Sirolimus, a substance that reduces the risk of rejection.
With conventional stent or balloon treatments, the risk of re-narrowing is about 8 to 10 percent. The Sirolimus-coated MagicTouch devices could potentially reduce that to about 3 percent. In addition, the devices help reduce the length of time a patient needs to be on blood-thinners.
Cardiovascular diseases are the leading cause of death globally. MagicTouch has been used on more than 25,000 patients worldwide, and has been the subject of ongoing clinical studies in the United Kingdom, Italy and Brazil.
“Our confidence in MagicTouch emanates from the positive feedback that we are receiving from the users of our product in many European countries,’’ Patel, a cardiologist, said in a release this week.
Last fall, Patel announced that he had invested $60 million in Concept Medical and would move its headquarters from Miami to Tampa. The company also has offices in the Netherlands, Singapore and Brazil.
Patel made his fortune selling HMO WellCare Health Plans for a reported $200 million in 2002. He and his wife, Pallavi, have donated tens of millions of dollars to bay area organizations, and in 2017 they announced gifts and commitments totaling nearly $225 million to build the Nova Southeastern University College of Osteopathic Medicine in Clearwater.
Patel is also part of FBN Partners, a group of local investors who in 2017 loaned $12 million to Times Publishing Co., which owns the Tampa Bay Times.
Contact Susan Taylor Martin at [email protected] or (727) 893-8642. Follow @susanskate.