Signaling what it said is a “new frontier in the use of transcatheter valve technology,” Medtronic (Minneapolis) has received the CE mark for its Melody transcatheter pulmonary valve with Ensemble transcatheter delivery system. The system, the company said, is “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 is designed to benefit patients with congenital heart defects involving the connection between their right ventricle and pulmonary artery. Often, 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 provides 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). “Through the process of obtaining [the Contegra],” she told Cardiovascular Device Update, “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/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 the 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
She noted that the company could have gotten a humanitarian device exemption for the system, but “we 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.”
Medtronic granted Aussie OK for Endeaver DES
Medtronic (Minneapolis) also reported receiving regulatory approval from Australia’s Therapeutic Goods Administration to begin selling the Endeavor drug-eluting coronary stent (DES) system. It said that the first commercial implants occurred at Monash Medical Centre (Melbourne). Monash and several other clinical sites throughout Australia and New Zealand initiated the Endeavor first-in-man experience in early 2003.
Medtronic said that with the approval, the Endeavor DES is commercially available in more than 100 countries, and the device — currently in clinical trials in the U.S. — is anticipated to receive FDA approval next year.
“The approval of the Endeavor drug-eluting stent is an important event for physicians and patients in Australia, as it brings a new medical technology to thousands of patients who suffer from cardiovascular disease,” said Dr. Ian Meredith, professor of medicine at Monash and principal investigator for ENDEAVOR I, the first study in a multi-phase trial evaluating the Endeavor. He performed the first commercial implant, and said: “I have followed the data for Endeavor very closely over the past three years and it has provided impressive clinical outcomes. The stent is effective at reducing restenosis and it has been proven to be among the safest stents on the market.”
He added: “Australia has been at the forefront of cutting-edge medical research for many years and I’m proud of the role the clinical centers have played in the development of this medical technology.” About 38,000 stents are implanted in Australian patients each year.
Max Muhs, vice president of Medtronic’s vascular business in the AsiaPacific region, said that the Endeavor stent would be available immediately. “We’re ready to supply the Australian market and very proud to make the Endeavor stent available to physicians and patients here.”
The Endeavor DES is made of a cobalt alloy and built on the same platform as the Medtronic Drive bare metal stent. In addition to the drug compound zotarolimus (ABT-578), Endeavor is coated with phosphorylcholine, a polymer designed to simulate the outside surface of a red blood cell and mimic the structure of the natural cell membrane, leading to an ideal healing response, according to Medtronic. Long-term data published recently in Circulation showed excellent clinical outcomes for the Endeavor, with sustained efficacy, low rates of adverse events and outstanding deliverability.
Heart attack ‘risk calculator’ in use
Pioneering computer software is helping doctors to decide how best to treat patients admitted to hospital with suspected heart attacks. An international consortium of researchers, led by the University of Edinburgh, has developed a program that enables doctors to swiftly assess the severity of a patient’s condition. The new “risk calculator” is already being used in British hospitals. Doctors using the new system take key data from patients at their bedside, and input it into the specially devised program. Those key facts — such as a patient’s age, medical history and blood pressure — are recorded by doctors, as well as information derived from on-the-spot blood samples and kidney tests.
The patient’s statistical profile is then input into a computer and matched with data derived from thousands of other coronary cases. Using the outcomes of these previous cases as a guide, the computer will not only give an accurate assessment of the new patient’s conditions, but also will recommend possible treatment. Significantly, it will be able to predict the likelihood of patients suffering a heart attack, and even their chances of dying in the next months.
Chest pain accounts for more than a quarter of all emergency medical admissions in the UK. Spotting high-risk heart patients quickly can be difficult, but Professor Keith Fox, of the University of Edinburgh, says the new tool will help: “Identifying those with threatened heart attack from the very many patients with chest pain is a real clinical challenge, but critically important in guiding emergency and subsequent patient care. Higher risk patients need more intensive medical and interventional treatment.”
An international group of cardiologists and statisticians have spent several years producing the Global Registry of Acute Coronary Events (GRACE) calculator. This statistical model has been developed using data derived from a six-year study of more than 40,000 coronary patients worldwide.
Fox added: “The device has recently been introduced into hospitals, following an additional two-year trial on coronary patients admitted to Edinburgh Royal Infirmary. This new risk assessment tool (freely available from http://www.outcome.org/grace) gives doctors a robust way of identifying high risk patients who need specialist treatment.”
St. Jude granted Atlas CE marking
St. Jude Medical (St. Paul, Minnesota) recently reported CE marking of its newest high-powered devices for treatment of patients with potentially lethal heart arrhythmias and heart failure (HF).
The Atlas II implantable cardioverter defibrillator (ICD) and the Atlas II HF cardiac resynchronization therapy defibrillator (CRT-D) devices include features providing more tailored therapy and speed follow-up visits for physicians and patients. The Atlas II devices also take advantage of the company’s newly released QuickOpt feature which helps physicians improve patient outcomes by providing programmer-based optimization in less than two minutes. The QuickOpt feature electrically characterizes the conduction properties of the heart and uses an exclusive algorithm to calculate the optimal timing values, allowing for efficient and frequent optimization during routine device follow-up visits. QuickOpt, the company said, “has proven comparable to a traditional echocardiography (echo) procedure for determining optimal device settings; however, echo optimization can be costly and time-consuming and typically takes between 30 and 120 minutes.
The Atlas II devices offer enhanced telemetry speed for faster communications — up to five times faster than predecessor devices — which results in quicker, more convenient follow-up visits for patients and physicians. Additionally, a “patient notifier” gently vibrates to alert patients, including those who have difficulty hearing, of critical changes in device function so they know to contact their physicians.
Dr. Christian Lampersberger, who implanted an Atlas II+ DR ICD at Landesklinikum (St. P lten, Austria), said, “The DeFT Response feature is very beneficial in that it provides a way to non-invasively manage those who may experience high defibrillation thresholds. Also, the QuickOpt optimization feature is exciting new technology, as it will help to provide more tailored therapy for patients and save clinic time.” Professor Luigi Padeletti implanted an Atlas II HF CRT-D at Careggi Hospital (Florence, Italy).
The Atlas II ICD and Atlas II HF CRT-D devices are two of more than 20 new cardiac rhythm management products that St. Jude Medical plans to introduce this year.
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 healthcare 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, PhD, chief operating officer of Conor.
Conor said 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.
The CoStar stent is still an investigational device in the U.S.
World Blood Market Exceeds $20 billion
Kalorama Information (New York) reported that the worldwide market for human-derived blood products, testing, and typing products, and plasma and blood collection equipment exceeded $20 billion at the end of 2005.
Kalorama said the total global value of blood products alone is just shy of $14 billion in 2005, with the lion’s share attributable to red blood cells (RBCs) at more than $7 billion.
Demand for immunoglobulins or antibodies stood at nearly $3 billion in 2005 and is rising by 6%-8% per year, making it the driving force behind plasma collection. Other human plasma-derived products, such as platelets, clotting factors, and alph-1 proteinase inhibitors, also played a significant role in strong revenues, valued at $2.5 billion, Kalorama said.
At the same time the blood products market escalates, so too are the markets for blood testing and typing products, blood collection equipment, and synthetic blood products. Nucleic acid tests, for example, currently at $953 million, are expected to increase by 11.5% to over $2 billion by 2012. Similarly, the market for recombinant factors, which currently stands at over $4 billion, is expected to rise to more than $7 billion by 2012.
"Global demand for blood products, particularly in developed countries where the technology is readily available and rapidly advancing will continue to rise at a healthy rate as the world population ages and requires increasingly intricate operations and testing," said Alison Sahoo, the report's author. "As they reach the market by 2007, we also anticipate the emergence of hemoglobin-based oxygen carriers and PFC-based products to play a significant role in market growth."
Kalorama Information, a division of MarketResearch.com, supplies independent market research for the life sciences.