Medical Device Daily
On the one hand is the “winged chariot” of time, a vehicle that the FDA can slow rather substantially – and often does. On the other hand is initial public offering (IPO) money that fuels the machine and expects accelerated results.
Those are the contending forces facing cardiovascular device maker Cardica (Redwood City, California) – and, of course, many other device makers – as it reports launch of a new study that it hopes will lead to clearance of its PAS-Port Proximal Anastomosis suturing system in coronary artery bypass grafting (CABG) procedures, best-case scenario as early as 2008, according to Bob Newell, company CFO.
In April 2005, Cardica went before the FDA's cardiovascular panel and, while it didn't get a formal vote against recommending the PAS-Port, it was told to go back to the regulatory drawing board and develop more data, the panel pointing to “gaps” in the data that had been pooled from two studies (Medical Device Daily, April 26, 2005).
The result for Cardica: at least a two-year delay in product commercialization.
“After the meeting, we withdrew our 510(k),” and then returned to the agency to win an investigational device exemption for a new study, Newell told MDD.
That has taken some time, working with the FDA on a new protocol, he said.
In the meantime, the company was the first pure device firm in 2006 to launch an IPO, gathering in, with sale of over-allotments, $32.6 million (MDD, Feb. 6/March 1, 2006), a move that helps the company push forward with its study but also puts on some pressure, via public disclosures and the close scrutiny of shareholders, Newell acknowledged.
It's now “life in a fish bowl,” he said. “But for us it's worth it, because the company is [now] capitalized in a way that we can move forward.”
Just launched, the company's new pivotal trial will enroll 220 patients at 10 centers in the U.S. and Europe, with the procedures using both the PAS-Port system and a hand-sewn suturing procedure in each patient to provide the study comparison – the vessels themselves randomly chosen, Newell noted.
The results will be compared using angiograms, with the company hoping to file its new 510(k) application to the agency by late 2007, potentially winning clearance in early 2008.
The PAS-Port system – already commercially available in Japan and Europe – creates a connection between a vein graft and the aorta, the main artery in the body, as part of the CABG procedure.
The current method of performing an anastomosis in a CABG procedure utilizes demanding and time-consuming hand-sewn sutures to connect a bypass graft vessel to the aorta and to small diameter coronary vessels.
Newell noted that besides showing that the PAS-Port provides as good a connection as hand suturing, it cuts a majority of minutes off the procedure time – requiring just two minutes, compared to the seven to 15 minutes for the hand-done procedure, as reported in the literature, he said.
Newell said this additional speed comes from the integration of processes that the system provides – “cutting the hole in the artery, pulling the plug out of the aorta, inserting the implant with vein graft attached, all in a matter of seconds. What really takes up the two minutes is loading and preparation.”
Additionally, according to John Puskas, MD, chief of cardiac surgery at Emory Crawford Long Hospital, associate chief of cardiothoracic surgery at Emory University (Atlanta) and principal investigator of the trial: “The PAS-Port system's ability to facilitate beating heart bypass surgery may reduce the risk of neurological complications and mortality associated with clamping the aorta during beating heart procedures.”
All patients will receive a follow-up angiogram nine months after the procedure to determine patency (openness of the vein graft) of both PAS-Port and the control grafts.
“The PAS-Port system appears to be the most technically advanced, highest-quality, consistently reliable device developed so far to automate and facilitate anastomoses during stopped and beating heart bypass procedures,” said Mark Connolly, MD, of Cathedral Advanced Cardiothoracic Surgeons, Saint Michael's Medical Center (Newark, New Jersey), a trial investigator. “The PAS-Port could prove to be a major step forward in facilitating mechanical anastomoses.”
The team of Connolly and Tyrone Krause, MD, performed the first procedure utilizing the PAS-Port system in the trial.
The company reports more than 3,500 PAS-Port systems sold in Japan and Europe and currently used in more than 10% of all coronary revascularization procedures in Japan.
It reports in previous clinical trials in Europe that the six-month patency rate with anastomoses completed with the PAS-Port system ranged from 87% to 98% compared to an average of 84% reported in the literature for hand-sewn anastomoses.
In 2006, an estimated 250,000 CABG procedures will be performed in the U.S., each requiring about five anastomoses, often considered the critical step of the surgery.
Cardica's C-Port Distal Anastomosis System is marketed in Europe and the U.S. The PAS-Port Proximal Anastomosis System is marketed in Europe and Japan.
Cardica also is developing additional devices to facilitate vascular and other surgical procedures.
Newell noted that because about three of five CABG/anastomoses procedures are done with a distal procedure and the other two done with a proximal procedure, Cardica's C-Port would bring it the larger profits. But he added that there are significant synergies being created by sale of the C-Port system and ongoing training.
Those already using the C-Port will be “the first customers that we would go back to,” he said.
Besides its IPO money, Cardica has received a $4 million investment from Guidant (Indianapolis) (MDD, Aug. 22, 2003) and a $500,000 milestone payment from Cook (Bloomington, Indiana) (MDD, May 9, 2006).