CorMatrix Cardiovascular (Marietta, Georgia), which is focused on developing extracellular matrix (ECM Technology) biomaterial devices that harness the body's ability to repair damaged cardiovascular tissue, said it has begun its expansion in Europe following the first use of the CorMatrix ECM Technology in a patient undergoing cardiac surgery.
Following implantation by a surgeon, the CorMatrix ECM Technology acts as a scaffold into which the patient's own cells migrate and integrate, stimulating the body's innate wound-healing mechanisms to repair tissue at the site of implantation.
As the patient's cells populate the matrix, they lay down their own collagen, which matures over time to form a functional tissue repair. The implanted ECM material is gradually replaced and reabsorbed by the body as the patient's tissue is remodeled.
The first procedure in Europe was completed in March by Stephan Jacobs, MD, and Volkmar Falk, MD, both of University Hospital Zurich in Switzerland, who utilized the CorMatrix ECM Technology to close the pericardium of a 70-year-old patient following triple coronary artery bypass graft surgery.
Jacobs hailed the ease of use of CorMatrix ECM, adding: "This is an advancement in cardiac surgery to restore the patient's normal anatomical structures, which we believe is in the patient's best interest."
"Our European launch further validates the increasing interest and acceptance that our ECM Technology continues to receive among the clinical community," said CorMatrix President/COO Beecher Lewis. "Because our ECM Technology supports native tissue repair, it represents a significant advancement over currently available materials."
The company's chief scientific officer, Robert Matheny, MD, said, "Closure of the pericardium is beneficial as it restores the natural barrier between the heart and the chest wall; it protects the heart, underlying grafts that were applied to the heart, and makes it easier and safer to re-access the heart if a subsequent procedure is required."
Since the launch of the CorMatrix ECM for pericardial closure, the technology has been used at more than 220 hospitals across the U.S. and has been implanted during more than 10,000 cardiac procedures.
CorMatrix Cardiovascular holds an exclusive license from Purdue University (West Lafayette, Indiana) to research, develop, manufacture and market naturally occurring ECM products for cardiovascular applications.
The company currently has U.S. clearance and European CE-mark approval for ECM as an implant for pericardial closure, and clearance in the U.S. for use in cardiac tissue repair.
EMEA issues stent guidance
The publication last year of a coronary stent guidance by the FDA regarding development of drug-eluting stents does not apply to bioresorbable stents, but that is not the case with a guidance published recently by the European Medicines Agency (EMAA; Brussels, Belgium) that deals with clinical development of coronary artery stents.
This guidance covers the entire range, including bare-metal (BMS) and drug-eluting stents (DES), as well as "innovative stents," a group said to include biodegradable stents and stents "incorporating completely new design concepts."
According to the guidance, a clinical trial for a bare-metal stent should run at least six months, whereas trials for drug-eluting and innovative stents should run a year. Follow-up studies should run "for a minimum of three years," and post-market studies may have to include registries that are open to all comers, including patients who have opted for stents outside labeled indications.
The guidance also notes that the resulting data "should be used to feed back directly into device labeling."
Clinical success for the device should be defined in a study as leaving no more than 50% residual stenosis in the affected artery, which can be ascertained by quantitative coronary angiography or by "visual estimation" if the first technique is not possible. The recommended clinical measures include cardiac and non-cardiac death and thrombosis.
Liberté gets Japan reimbursement
Boston Scientific (Natick, Massachusetts) reported the launch of its Taxus Liberté paclitaxel-eluting coronary stent system in Japan. The drug-eluting stent (DES) was approved by the Ministry of Health, Labor and Welfare on Jan. 28, and reimbursement was granted by the National Health Insurance System last month.
The company said Taxus Liberté is the only second-generation DES available in Japan.
It said design improvements over the first-generation Taxus Express2 stent include thinner struts to allow better stent deliverability and conformability, as well as uniform stent geometry for consistent lesion coverage and drug distribution.
"We are ... pleased to launch Taxus Liberté as the only second-generation drug-eluting stent in Japan," said Maulik Nanavaty, president of Boston Scientific Japan. "Boston Scientific has already established a diversified product portfolio in the coronary intervention field, and we are committed to building on these ... treatment options for Japanese patients with coronary artery disease."
Roughly 1,300 medical centers perform cardiac catheterization in Japan. The number of coronary stents implanted annually in the country is estimated at 200,000.
1st MitraClip procedures in Switzerland
Evalve (Menlo Park, California), a developer of devices for the percutaneous repair of cardiac valves, reported that the first series of patients have been treated with the company's MitraClip system at the Cardiocentro Ticino (Lugano, Switzerland).
The MitraClip system is the only medical device commercially available in the European Union that provides a non-surgical mitral valve repair option for patients suffering from the effects of functional and degenerative mitral regurgitation (MR).
Evalve said mitral regurgitation is the most common type of heart valve insufficiency in Europe and the U.S., affecting millions of people worldwide. In most patients, the MR is untreated, requiring the heart to work harder and ultimately leading to heart failure.
The first patients in Switzerland were treated by a team led by T. Moccetti, MD, who said, "Until now, many heart failure patients with associated functional MR had no therapeutic options except medical management when surgery was not possible either because they have already had heart surgery, or presented with important renal insufficiency or lung disease, all of which significantly increase the risk of a second or a third operation."
Evalve initiated commercial sales of the MitraClip system in Europe under the CE mark last September. The company said it is employing a direct sales strategy and is taking a "disciplined and measured approach to the initial commercial roll-out."
The MitraClip device is now currently being implanted in Germany, Italy, the UK, the Netherlands and now Switzerland.
Evalve is the first portfolio company from the medical device company incubator, The Foundry (also Menlo Park).
1st enrollees in Perceval S trial
Sorin Group (Milan, Italy), a leading developer of devices for the treatment of cardiovascular diseases, reported the enrollment of the first three patients in a clinical trial aimed at obtaining European market approval for its Perceval S Sutureless Aortic Heart Valve.
In a previous first-in-man pilot study, 30 patients at high surgical risk were enrolled in three European centers. The new Perceval S clinical trial will involve some 150 patients at high surgical risk in nine European centers.
The first three implants of the clinical trial were performed at the Institut Mutualiste Montsouris (IMM) in Paris.
"We successfully implanted the first three patients in this important trial. I was able to appreciate the innovative characteristics of the device in terms of safety, procedural success and clinical outcome," said Fran ois Laborde, MD, chief of cardiac surgery at IMM hospital. "This valve allows the removal of the diseased valve, precise positioning and fast release and implantation, and therefore, ultimately a significant reduction of surgical time."
Sorin Group's Perceval S valve is a bioprosthesis made of a bovine pericardial tissue assembled on a super-elastic metal alloy stent. The valve evolved from the Pericarbon Freedom Valve, a well-established Sorin Group pericardial stentless valve that has been sold in Europe since 1991.
Among the benefits cited by the company for the new valve are reduced implantation time vs. conventional stented aortic valves, well-established bovine pericardial valve design, super-elastic metal alloy stent, optimal aortic wall anchoring and sealing, and exclusive detoxification treatment.
"This ... prosthesis is designed to be implanted using a quick metal stent deployment technique, thus obviating the need for using time-consuming, conventional suturing techniques," said Sorin CEO André-Michel Ballester.
ESC reaffirms advice on VTE risks
Following a review by The Lancet of the medical issues associated with commercial air travel, the European Society of Cardiology (ESC; Sophia Antipolis, France) has reaffirmed its advice about the risks of venous thromboembolism (VTE), whose risk, according to the Lancet article, is increased "up to four-fold" by long-haul flight.
Dr. Steen Kristensen, VP of the ESC, said, "Long-distance flying is associated with an increase in deep venous thrombosis, which in some cases may lead to clotting of the lungs. People who are immobile, pregnant, taking contraceptive pills or have had venous thrombosis in the past are particularly at risk. The use of compression stockings is for some travelers an important way of preventing deep venous thrombosis."
Studies cited by The Lancet suggest that the risk of VTE increases when flight duration exceeds four hours. This raised risk is related to immobility, dehydration, and reduced oxygen in the cabin, as well as to individual risk factors such as obesity, recent surgery and predispositions to thrombosis.
The ESC said it is in the process of preparing a policy statement on the safety of commercial air travel for cardiac patients.
More Thailand training by Cardima
Cardima (Fremont, California) said it has completed its second phase of training for cardiothoracic surgeons in Thailand on the use of the Cardima Surgical Ablation System, a closed-chest procedure for the treatment of atrial fibrillation (AF).
Cardima's electrophysiology product lines and Surgical Ablation System have received product registration approval in Thailand.
The three-day training session was performed under the direction of Li Poa, MD, chief of cardiothoracic surgery and cardiac surgery program director at Stamford Hospital (Stamford, Connecticut) and faculty member of Columbia University College of Physicians and Surgeons (New York).
Poa worked closely with Dr. Suchart Chaiyaroj, chief of cardiothoracic surgery at Ramathibodi Hospital (Bangkok) and a member of the faculty of medicine of Mahidol University, and his associate, Dr. Khanat Kruthkul.
Three patients were treated during this session, bringing the total number to seven patients treated using the Cardima Surgical Ablation System under the Thai training program.
Poa noted, "The Cardima system is capable of creating a fairly complete, complex lesion set for the minimally invasive surgical treatment of lone AF with the establishment of both pulmonary vein and antral isolation, ablation of the right-sided gangliae and posterior inferior vena cava, and a crossing closed-loop lesion of the coronary sinus isthmus."
He added that the Thai physicians who observed the procedures and participated in the training "were very impressed by the minimally invasive nature of the procedure, its ability to create complex and deep lesion sets, the speed at which it can be completed, the visualization available to surgeons and the fact that patients are discharged the following day. They are very supportive of our efforts to establish a strong AF treatment program, as well as an AF Center of Excellence in Thailand."
Several institutions and individuals have provided support for the development of such a Center of Excellence in Thailand.
Suchart is leading the training initiative on behalf of Ramathibodi Hospital, along with the support of Professor Rajata Rajatanavin, dean of the faculty of medicine, and others at both the hospital and university.
"Learning this new minimally invasive procedure for the effective treatment of AF is an exciting development for our surgical team at Ramathibodi," said Suchart. "My surgical team and EP colleagues have been extremely impressed by the procedure developed by Dr. Poa. We believe this very minimally invasive procedure opens a tremendous new treatment option for patients."
Cardima is focused on the treatment of AF with a product line that includes the Cardima Surgical Ablation System and the Revelation line of EP catheters.
German trial nears for Pluristem
Pluristem Therapeutics (New York) said it has completed several key steps in preparation for the upcoming clinical trial in Germany of its placental-derived stem cell product candidate PLX-PAD.
The initiatives included a dry run of PLX-PAD preparation for injection, and verification of the process flow involved cell delivery to the clinical sites. The trial will involve patients with critical limb ischemia.