Medical Device Daily Associate

CoreValve (Paris) this week reported the milestone of 50 patients treated in trials with its delivery system for percutaneous aortic valve replacement (PAVR).

The 50 patients who were treated underwent the PAVR procedure at seven investigative sites in Germany, Holland, Belgium and Canada, in a beating heart with the percutaneous ReValving System to treat either their aortic stenosis, aortic regurgitation or failed-tissue-valve-prosthesis conditions.

“One hundred percent of the patients discharged from the hospital continue to demonstrate improved cardiac function, zero long-term complications and enjoy substantially enhanced quality-of-life at follow-up out to 14 months,“ said Jacques Seguin, MD, PhD, chairman, CEO and founder of CoreValve, a cardiac surgeon who had performed some 4,000 open-heart surgeries before becoming a medical device entrepreneur.

What is noteworthy, he said, is that all of these patients were considered very high risk and they otherwise would have been left untreated because they were contraindicated for the only other treatment alternative: open-heart surgery.

“Considering that if left untreated, all of these individuals would have experienced a nihilistic quality of life during their remaining time, and that 25% of them faced the certainty of death within 12 months – we are thrilled to have been instrumental in returning these ReValving patients to a normal lifestyle where they can expect to continue enjoying time with their loved ones.“

Rob Michiels, president and COO of CoreValve, told Medical Device Daily that since August 2005, 36 patients have been treated with the company's self-designed, second-generation, 21 Fr-sized system.

He said that the downsizing of the catheter (the first generation was an off-the-shelf 24 Fr catheter that was attributed to four deaths in a group of very sick patients) greatly improved the ease of the procedure and, with the exclusion of prep time, the second-generation system is “now routinely facilitating access, delivery and placement of our porcine pericardial-tissue bioprosthesis in less than 15 minutes. Consequently, our accomplished investigators are scheduling two procedures during the same day.“

The Revalving System consists of four parts: a self-expanding, multi-level nitinol frame, onto which a porcine pericardial tissue valve is mounted. It is then delivered by means of a 21 Fr catheter and a disposable loading system.

The key to the system, said Michiels, is the nitinol frame. It first holds the valve and then “collapses and fits into the catheter for insertion. It's easy to deploy and position, [and] anchors solidly in the anatomy. It adapts itself to the cylindrical anatomy of the annulus and allows blood flow during the deployment phase.“

The frame technology has several functions, he said. Its “very high radial force anchors itself on the aortic annulus while trapping the patient's diseased valve between the frame and the annulus. . . The upper outflow part has the lowest radial strength and it implants itself on the ascending aorta and acts as the prosthesis parallel to the blood flow.“

Michiels said the company's goal is to have two sizes of valves that will fit all patients from 20 mm to 27 mm.

“We would place a 26 mm [self-expanding] frame in any annulus between 20 mm and 23 mm because we want to have anchoring pressure, of course. And then we would place a 29 mm frame in any annulus between 23 mm and 27 mm,“ he said.

Within a few months, Michiels said the company plans to initiate the use of a third-generation system, which has been further downsized to 18 Fr. He believes this will bring added procedural benefits to the interventional cardiologist.

He said both the 24 Fr and 21 Fr catheters require a cutdown – creation of a small incised opening – to allow the catheter to be inserted. The 18 Fr catheter will not require a cutdown and hence will be an even more minimally invasive approach.

The company has stated that its goal is to ultimately get this down to a 14 Fr model for even better ease of delivery of the revalving system.

Seguin has previously pointed out that the open procedure takes about two hours and the time between insertion and retrieval of the ReValving catheter takes less than 15 minutes.

As for U.S. trial plans, Michiels said the company intends to submit an investigational device exemption by the end of the year and hopes to initiate a clinical trial here by the beginning of 2007.

On the organizational side, the company has been very successful, with A- and B-round financing of about $30 million, the $24 million B round coming last year (Medical Device Daily, July 12, 2005). Michiels said that about $20 million of that is still in the bank, enough to support the company through mid-or late-2007, “which would mean that we have money to take us through the CE-marking of the product and the start of U.S. trials, but obviously not through the end of U.S. trials.“

While future financing could be in the form of a C round, Seguin previously told MDD that the company is “strongly considering“ an initial public offering.