Inside Carbomedics
During my research on the relationship between Carbomedics (CMI) and Manny Villafaña, I received a detailed account from Paul Stein, who generously shared background information and written notes on the evolution of the bi-leaflet valve market.
According to Paul’s material, CMI’s early strategy focused on developing an inexpensive mechanical valve for the rapidly growing Chinese market. The project was initially called the PRC (People’s Republic of China) valve, but it never progressed beyond the concept stage, as Pacific Biomedical had already entered the market.
Paul explained that Carbomedics engineers created two design alternatives—PRC1 and PRC2. PRC1 featured a pivot design similar to the St. Jude Medical (SJM) valve, while PRC2 incorporated an open-pivot configuration.
When Carbomedics and St. Jude later entered into litigation over design similarities, Carbomedics decided to commercialize its own valve. The PRC1 design was chosen and became the company’s proprietary CarboMedics Prosthetic Heart Valve (CPHV). The PRC2 blueprint, meanwhile, was archived.
By the early 1990s, Paul noted, CMI sold the PRC2 valve design concept to Manny Villafaña, who used it as the foundation for the ATS Open Pivot Heart Valve—his effort to re-enter the mechanical valve market and challenge St. Jude’s dominance. However, when negotiating with Carbomedics, Manny underestimated the global traction CMI had already achieved and made sales commitments that later proved unsustainable.
Ultimately, Manny was released from his role at ATS Medical, ushering in the Michael Dale era. Under Dale’s leadership, ATS renegotiated its agreement with Carbomedics and prospered for several years—until its acquisition by Medtronic in 2010.
Companies now had access to a biocompatible, durable material that enabled innovative designs to reduce turbulent blood flow. This lowered the thrombogenicity (the tendency to clot) of MHVs and minimized the formation of emboli (detached thrombi traveling through the bloodstream).
I could easily compose a seductive story to deliver when meeting savvy heart surgeons working under him. Bokros assembled a gifted group of engineers who took design concepts and formatted tools to a new level of excellence. Manufacturing a particular valve model efficiently, without variance, became standard practice.
The St. Jude Medical founder Manny Villafaña was already aware of the Bokros-CMI plan. Paul revealed that CMI’s initial strategy involved developing an affordable valve tailored for the rapidly expanding Chinese market.
Originally called the PRC (People’s Republic of China) Valve, this project did not progress. However, it’s important to note that CMI’s engineers developed two design alternatives: the PRC-1 and PRC-2. The PRC-1 had a pivot design similar to the SJM valve and the PRC-2 went with an open pivot configuration.
When CMI and SJM battled in the courts, CMI decided to commercialize its heart valve, the PRC-1 becoming the company’s proprietary valve —officially the “CarboMedics Prosthetic Heart Valve” (CPHV). Call it the “Carbo” Valve, or whatever you want, but heart surgeons and thought leaders had to be in CMI's camp, whatever the cost. That’s what mattered as the organization gained a position of power in the cardiology and surgical sectors of the industry. Safely living under the Intermedics umbrella challenged Medtronic as a competitor strong in both areas. A pacemaker or heart valve could keep your heart healthy, ticking away for decades —they were an expensive pair of devices that must perform without fail.
The Wada Dilemma
I often ran into Dr. Wada when based in Tokyo for Shiley. The light-hearted but dedicated surgeon, with a mechanical valve bearing his name—the Wada-Cutter—had a good grasp of English, communicating with sarcasm, innuendo, and comedy. The Cutter valve design matched that of the early Shiley spherical-disc model but only stayed on the market from 1967 to 1972. The model was withdrawn due to early disc-occluder wear, disc dislodgment from the valve ring, and massive thrombosis.
An influential and fascinating figure to be around, Dr. Wada performed Japan’s first heart transplant in 1968. Shockingly, he faced a murder charge by the police. At the time, Japan lacked clear legal standards for a patient to be diagnosed as “brain dead.” The donor in this case was officially declared brain dead by an attending doctor and committee, which sparked a mammoth controversy. Since the donor’s heart continued beating, it remained viable to explant and use in transplantation surgery.
This transferred its power and magnificence to a sick recipient, but a brain devoid of activity did nothing for the donor’s viability. I wondered: Why not harvest the power of a beating heart to save a sick individual’s life?
Dr. Wada kept his patients alive and deserved the label of “hero,” not “murderer.”
The Palm Reader
Years earlier, long before Jackie and I met, a Thai palmist named Sombat traced the lines of my hand beneath the faint yellow glow of a single bulb. His finger followed my lifeline as if charting a river.
“You will marry before forty,” he said softly, “and grow rich soon after.”
He got the first part right. The second took its time—though I did win a few thousand dollars on a Super Bowl bet, which he might have counted as partial credit.
When I returned to Bangkok in 1989, curiosity led me back to his small shop. Sombat examined my palm with the same steady focus, his brow furrowing as he leaned closer. Finally, he looked up with something like regret.
“You will lose someone you love,” he murmured, “but you will keep your purpose.”
I stepped back into the street, the smell of incense giving way to exhaust and frying noodles. The city roared, but his words stayed quiet inside me.
He read my future in lines of fate; Asia would teach me the rest in gestures.
