Medical Device Daily National Editor
Minimally invasive this, minimally invasive that.
As catch-phrases go, minimally invasive has taken on a life of its own in the world of surgery.
Nowhere is that more true than in the cardiovascular sector. Where once many surgical procedures were done by quite literally cracking open the chest, the push toward doing them in the current decade, well, minimally invasively, has become, if not the norm, at least a very significant part of it.
One of the key players in the minimally invasive cardiovascular sector is the aptly named CardioVations (Somerville, New Jersey), which has just launched its Port Access Precision Series, a new line of surgical instruments for use in minimally invasive heart valve repair procedures.
CardioVations is a division of Ethicon (also Somerville), with both being Johnson & Johnson (J&J; New Brunswick, New Jersey) companies.
Richard Kaeser, director of sales and marketing at CardioVations, told Medical Device Daily in a phone interview that the company's new line of instruments reflects the growing consumer interest in minimally invasive approaches.
"It's incredibly patient-driven," he said of the movement toward minimally invasive approaches.
One of the companies that early on helped spur the interest of patients in demanding less-invasive surgical solutions was Heartport , which was acquired by J&J in April 2001 and made part of CardioVations, a company the medical products giant had formed in the latter part of the last decade to take new, innovative looks at the cardiac surgery field.
Heartport pioneered the Port Access approach to a variety of heart surgery procedures, but, as Kaeser noted while reflecting on that company's legacy, it was a bit ahead of the curve of cardiac surgeons' response to the new type of approaches.
"The original Heartport instruments were so highly regarded by doctors," he said, "they were just amazing." But there simply wasn't a rapid enough response from the rather tradition-bound docs in the sector.
While today it seems like there's a vast amount that is new and widely accepted in the area of cardiovascular advances, the truth is that it is a medical discipline where sticking with the tried and true – coronary artery bypass surgery or angioplasty being high-profile cases in point – is commonplace.
After years of trying to make it in a marketplace that wasn't quite ready to embrace it, the Redwood City, California-based Heartport became part of J&J's push to diversify by building a broader medical device component. For the fire-sale price of $81 million, its intellectual property and the technology emanating from that IP came under the CardioVations umbrella.
The Port Access products being rolled out by CardioVations this month reflect the Heartport heritage. Initially including scissors, forceps and needle holders/drivers in a variety of sizes and a range of surgical functions, the instruments are designed and built for CardioVations by Jakoubek Medizintechnik (Liptingen, Germany), a highly regarded manufacturer of medical instruments.
They are made of titanium and stainless steel, and in CardioVations' words, "are built to withstand the rigors of repeat use and sterilization, while maintaining the same high levels of performance in every procedure."
In announcing the new line, the company cited statistics indicating that something more than one-quarter of the roughly 27,000 mitral valve repair procedures performed each year are done minimally invasively. And Kaeser noted that while the market for mitral valve procedures is growing at something approximating 7% a year, the minimally invasive portion is growing at between two and three times that rate.
The American Heart Association (Dallas) helped spur that growth by adopting new guidelines last year encouraging cardiac surgeons to intervene earlier to resolve heart valve problems.
Port-access valve surgery allows surgeons to operate through small openings, or ports, between the ribs, eliminating the need to cut through the breastbone.
Kaeser said the minimally invasive approach gives surgeons a better view of the surgical site than the traditional approach. "You don't get as good access through the open-chest approach as you do with this," he said. Rather, with the port-access approach, "you're looking right down on the mitral valve."
The data on use of the instruments "is amazing," he said, adding: "We have lots of customers waiting for these products."
One, Dr. J. Alan Wolfe of St. Joseph's Hospital (Atlanta), said in a company statement that the introduction of the Port Access Precision Series is "great news for the growing number of patients undergoing minimally invasive valve repair."
Wolfe said the instruments "position the surgeon to deliver high levels of accuracy and control while also offering important advantages in durability, ease of sterilization and ease of use."
According to CardioVations, the flushport design allows for automated processing and intraoperative flushing, "designed to help maintain a high level of instrument performance."
In rolling out the new instruments, the company noted that minimally invasive valve surgery is performed via one or more small incisions between the ribs. That approach, it said, "typically results in reduced trauma and pain, less scarring and shorter hospital stays for patients."
Kaeser said that nationwide distribution of Port Access Precision instruments was beginning immediately.
"They are literally going out the door as we speak," he said during our interview.
He acknowledged that reimbursement hasn't yet been established yet, but, "we're working on it."