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Manuel A. Villafaña: From life at the bottom to a remarkable career in cardiovascular medicine

By ELISABETH ROMAN of Caribbean Business

July 7, 2005
Copyright © 2005 CARIBBEAN BUSINESS. All Rights Reserved.

It is hard to believe the world of cardiovascular medicine would be the same without Manuel "Manny" A. Villafaña.

This Puerto Rican entrepreneur has come a long way from the poverty and crime-ridden streets of the South Bronx neighborhood where he grew up, defying all odds to become a leader in cardiovascular medicine. Since the 1970s, Villafaña has successfully founded six publicly held corporations, co-developed the St. Jude heart valve, co-invented the first open-pivot heart valve, and is the recipient of various pacemaker, heart valve, and stent-type connector patents. Villafaña went from running through the alleys of New York City’s South Bronx to becoming a pioneer in Minnesota’s "Medical Alley." All this he did with just a high-school education.

Thanks to Villafaña’s contributions to the state’s healthcare industry, Minnesota now is known as Medical Alley and is the only state in the nation where healthcare is the No. 1 industry.

Today, the graduate of Cardinal Hayes High School in the Bronx, whose father was born in Morovis and whose mother was a native of Santurce, is well-known among the academic circles and medical communities worldwide. Villafaña has lectured at major universities and organizations including Harvard University School of Business, Miami University of Ohio School of Business, the University of Minnesota School of Business, the Japanese Society for Artificial Organs in Tokyo, the Japanese College of Cardiology in Yokahama, La Sociedad Mexicana de Cirugía Cardiovascular in Veracruz, and the International Society of Cardiothoracic Surgeons.

"I was very fortunate to attend a great high school in the South Bronx, which was run by various religious priests and brothers. I received a very good education at Cardinal Hayes, but couldn’t afford to go to college in those days. That was before student loans," said Villafaña, who ended up working in several odd jobs until he was hired by a firm that needed someone familiar with sales and who also knew Spanish.

"I applied and got the job with a company called Picker International in White Plains, N.Y., which was the export wing of Picker X-ray. At the time, Picker was the largest X-ray [machine] manufacturer in the world," Villafaña said, adding that one of the products exported by Picker was produced by a company called Medtronic Inc.

Medtronic, a manufacturer of pacemakers, quickly recognized Villafaña’s potential and offered him employment. "That was 38 years ago," he said. Villafaña spent five years as Medtronic’s Latin American sales manager. "The company sent me to Argentina, where I spent two years, and Puerto Rico was part of the territory I covered."

While Villafaña doesn’t have a college degree, thanks to the hands-on experience and education received at Medtronic, he knows more about pacemakers and heart valves than the average doctor or possibly anyone in the world. Villafaña says he is an avid reader of all types of technical materials and "by using common sense, you can become a great engineer. The brain retains it."

After Medtronic, Villafaña went on to establish several companies in Minnesota, starting with Cardiac Pacemakers Inc. (CPI), which today is known as Guidant and is extremely successful. At CPI, he helped create the first long-life pacemaker. Villafaña notes that when he first started out, pacemakers weren’t as long-lasting as they are today.

"I was involved in the design of the first long-life pacemaker, which is the CPI pacemaker. In the 1970s, when I began, pacemakers had a life of 12 to 18 months, sometimes 24 months. I helped develop a better way of making them, and now they have a life of 30 years," Villafaña stated. "The first pacemaker I made with my own hands is still working, and it’s over 33 years old."

Before establishing CPI, things were difficult for Villafaña, and the devout Catholic turned to his faith for help. "I was struggling to put together a company, and no one paid attention to me. I ended up in church one day and found a card with a novena to St. Jude [patron saint of desperate cases]. I started the novena and went on to establish my first company, CPI," said Villafaña. "When my son was born 32 years ago, I named him Jude in honor of the saint and, when he was born very ill, I turned to St. Jude for help. Today, he is a 32-year-old young man with his own company and doing well. As a result of my son’s recovery, I decided to call my second company St. Jude Medical Inc."

Villafaña sold CPI in 1978 and founded St. Jude Medical, where he co-invented the first St. Jude heart valve, considered to be the most commonly used cardiovascular device in the world, with over 1.5 million patients who have the valve. Villafaña later took St. Jude public. Today, it is one of the largest medical-device companies in the world, with sales of more than $2.3 billion.

After St. Jude, he went on to co-found GV Medical Inc. in 1982 and ATS Medical Inc. in 1987. At ATS, Villafaña co-invented the first open-pivot heart valve, a mechanical valve made of pyrolytic carbon. Villafaña’s latest project is a start-up company in the field of cardiovascular surgery. He founded CABG Medical Inc. in 1999 and is currently working on new ways of performing cardiac surgery.

"The project we are working on now is a new way of doing cardiac surgery. Bypass surgery can be carried out without having to remove vessels from your legs or arms to place in your heart. For example, former President Bill Clinton’s quadruple bypass surgery took eight hours to complete. We did a quadruple bypass with our new method about a month ago, and it only took about 2_ hours," explained Villafaña. "This project is potentially five or 10 times bigger than anything I’ve ever done."

Despite his tremendous success, Villafaña, who has been married to his greatest friend and supporter, Elizabeth Elder of Mason City, Iowa, for the last 21 years, and is the father of nine-year-old twin girls, Elisa and Manuela, hasn’t forgotten his humble beginnings and remains actively involved with the community, dedicating time to the Kips Bay Boys & Girls Club of New York and other charitable organizations.

"I lived at the bottom and never forget it. When I used to walk home to 139th Street in the South Bronx, I was the kid who dodged through the back alleys to get away from the gangs; and I practically grew up in a Boys Club," Villafaña says with pride. "In 1991, the New York Times published a story about the very same street I grew up on and called it ‘Life at the Bottom.’"

Taking on the coronary bypass

For Manny Villafaña nothing seems impossible when it comes to healing the heart, and in his latest venture, he has taken on what is possibly the most primitive procedure in the cardiovascular industry: coronary bypass surgery.

The typical bypass surgery, which requires two surgeries: one to remove healthy vessels from the patient’s legs or arms for use in the bypass, and another which is the actual open-heart procedure to bypass the clogged artery with the harvested vessel.

Villafaña’s latest company, CABG Medical Inc., which stands for Coronary Artery Bypass Graft, seeks to bring this primitive procedure into the 21st century by developing the technologies and therapies of coronary heart disease by advancing conventional bypass surgery.

CABG’s first product, the Holly Graft System, is designed to eliminate the second surgery required to harvest healthy vessels, improving the patient’s experience by eliminating the wound pain, complications, and scarring to the legs and arms. Traditional vessel harvesting is highly invasive and painful, requiring an incision from the patient's ankle to groin.

Many companies have tried developing artificial grafts in the past, but now it’s Villafaña’s turn at bat. "This is no easy challenge. We’re swinging for the fences on this one. This is Mickey Mantle time," stated the Yankees fan, who could see the stadium from his apartment window in the Bronx, to a healthcare industry publication.

With bypass surgery representing a market that is 10 times the size of valve replacement and five times that of pacemakers, Villafaña’s latest venture is expected to be his biggest hit.

In June, CABG announced it has received approval from regulatory authorities to evaluate the Holly Graft System in clinical trials at various centers in Germany. "The approval to begin clinical trials in Germany allows us to begin the evaluation of our technology in what we believe will be the third-largest worldwide market for the Holly Graft System," said the Chairman & CEO of CABG Medical.

"The approval to begin clinical trials represents a tremendous opportunity for CABG to begin working with some of the largest hospitals in the world and an expanded base of qualified physicians."

"Our first patient implanted in November 2004 continues to experience life symptom-free," Villafaña says with pride.

Trials & Tribulations of an Entrepreneur

Despite his busy schedule, Manuel "Manny" Villafaña still finds time to travel all over the world teaching others how to succeed as an entrepreneur. In a lecture series called "The Trials & Tribulations of Being an Entrepreneur," Villafaña provides valuable advice for entrepreneurs.

"To be successful, there are many things you have to remember," Villafaña explained. "The first is you’ve got to have a spark, and I present a slide as part of my lecture that reads ‘The greatest pleasure in life is doing the things people say can’t be done.’"

Villafaña also presents a slide bearing a quote from Charles Duvell, who headed the U.S. Patent Office over 100 years ago. "Back in 1899, Duvell publicly said everything that can be invented already has been invented."

As part of his presentation, Villafaña urges those in attendance to look under their shirts or blouses and see if there is a big "S" (for Superman) underneath.

"If you are just an ordinary man or woman, you aren’t going to make it. You have to believe you are better than the average Joe or Jane to get started."

Villafaña advises would-be entrepreneurs to be prepared to swim with the sharks, "because when you start forming a company, many times you have to raise your capital, and there are going to be many sharks trying to take a piece of you while you’re doing it."

The successful entrepreneur also says honesty and teamwork are an integral part of success. "You can’t do this by yourself. You have to form a team of people; surround yourself with good people, not necessarily with your friends, but with good people."

Finally, Villafaña advises entrepreneurs to remain focused. "Don’t get distracted by other things, stay focused and go forward."

"These are the key things I discuss in my lectures," Villafaña said, adding that you have to be gentle with the people around you.

"The people you meet on the way up the ladder will be the same ones you will see if you have to come down the ladder. That’s my philosophy."

This Caribbean Business article appears courtesy of Casiano Communications.
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