Medical Device Daily Associate

Signaling what it said is a "new frontier in the use of transcatheter valve technology," Medtronic (Minneapolis) has reported receiving the CE mark for its Melody transcatheter pulmonary valve and Ensemble transcatheter delivery system.

The system is, the company said, "the first of its kind worldwide" to treat congenital patients with structural heart disease requiring pulmonary heart valve replacement.

The Melody valve and Ensemble delivery system are designed to benefit patients with congenital heart defects involving the connection between their right ventricle and pulmonary artery. Oftentimes, this type of defect requires open heart surgery early in life to implant a prosthetic valved-conduit to establish adequate blood flow from the heart to the lungs. However, the functional life span of these conduits is relatively limited and, as a result, most patients with this type of defect are committed to multiple open heart surgeries.

The Melody valve/Ensemble system provide a non-surgical means to restore effective valve function and prolong the life of prosthetic conduits, thereby reducing the number of open heart surgeries for these patients throughout their lifetime, according to Medtronic.

Vickie Conley, director of market development for transcatheter valves at Medtronic, noted the company's purchase of the assets for a surgical conduit called the Contegra in 2001 from VenPro (Irvine, California) (Medical Device Daily, March 1, 2001).

"Through the process of obtaining [the Contegra]," she told Medical Device Daily, "we also became engaged in the research that Professor [Philipp] Bonhoeffer had with NuMed [Hopkington, New York], a small pediatric catheter company."

Medtronic partnered with Bonhoeffer, chief of cardiology and director of the catheterization lab at Great Ormond Street Hospital for Children (GOSH; London) and NuMed, in the development of the Melody Valve and Ensemble system.

A pioneer in transcatheter valve technology, Bonhoeffer implanted the world's first transcatheter valve in September 2000. To date, more than 150 patients worldwide have been implanted with the Melody transcatheter pulmonary valve.

According to the American Heart Association (Dallas), congenital heart defects are the No. 1 birth defect worldwide. In the U.S., more than 25,000 babies are born each year with a congenital heart defect. About 22% of those born with congenital heart disease have defects disrupting the blood flow from the right ventricle to the pulmonary artery. Patients with this condition tire easily, since the heart over-exerts trying to get oxygenated blood throughout the body.

Medtronic says the transcatheter valve technology represents a less invasive means to treat heart valve disease, meaning that they physician can deliver replacement valves via a catheter through the body's cardiovascular system, rather than via open procedure through the chest.

"To reopen the chest many times is obviously uncomfortable for the patient but also comes with risk. By using the Melody valve and Ensemble system, we can now avoid the open chest procedure and instead perform the same procedure safely, quickly, and more comfortably," Bonhoeffer said.

"While the population that will benefit from this new technology is relatively small, Medtronic is committed to patient-centered lifetime management of congenital heart disease," said Oern Stuge, MD, senior vice president/president of the Cardiac Surgery business at Medtronic. "By providing less invasive options for physicians and therefore eliminating even one open heart procedure for a patient, we improve that patient's quality of life immeasurably."

Conley said that the CE mark approval gives Medtronic the ability to train and educate physicians in Europe in preparation for implanting the Melody and Ensemble system

While the Melody Valve and Ensemble System are not currently available in the U.S., Conley said that Medtronic has been working with the FDA "for a long time" to get a feasibility trial at three sites

While she noted that the company could have gotten a humanitarian device exemption (HDE) for the system, "we as a company chose not to go that route. We chose to go for the full indications and a full clinical. We decided to do that because we really do want to enter this market and we want to have the clinical indications for this product."

CV therapeutics wins Europe, U.S. patents

CV Therapeutics (Palo Alto, California) reported receiving notices of allowance from the European Patent Office and also the U.S. Patent and Trademark Office for its biopolymer stent coating technology.

The company said that preclinical study results suggest that the technology could potentially improve the performance of stents coated with drugs such as paclitaxel or rapamycin, by limiting cracking and peeling following implantation. It said those studies show that the coating "does not entomb the drug and is designed to control drug release rate more precisely and allows for the complete release of drug, leaving a bare metal stent (BMS) in place. It said the inflammatory responses and biocompatibility observed in preclinical studies are similar to results seen with BMS devices.

CV Therapeutics is focused on applying molecular cardiology to the discovery of novel, small molecule drugs for the treatment of cardiovascular diseases.

Conor gets extended shelf life OK

Conor Medsystems (Menlo Park, California), a developer of vascular drug delivery technologies, reported receiving regulatory approval for extending the shelf life of Conor's CoStar cobalt chromium paclitaxel-eluting stent in the European Union to 12 months from the current shelf life of six months.

"We are pleased to provide health care professionals the CoStar stent with this extended shelf life, which we believe will allow hospitals and our distributors to better manage their inventory," said Azin Parhizgar, P.D, chief operating officer of Conor.

Conor says that its stents have been specifically designed for vascular drug delivery by incorporating hundreds of small holes as reservoirs into which drug-polymer compositions can be loaded. In addition, the CoStar stent uses bioresorbable polymers absorbed by the body after the drug is released, leaving behind no residual polymers.