Medtronic Inc. (NYSE:MDT) announced Tuesday that its CoreValve System, designed to enable the replacement of a diseased aortic valve without open heart surgery, showed health improvements over a two-year period on patients implanted with the device. The CoreValve device won CE Mark approval in 2007.
The two-year study involved 126 patients at nine centers in Europe and Canada. The Fridley, Minn. company released the data at EuroPCR in Paris, France, an annual event that highlights the latest techniques, updates and breakthroughs in cardiovascular science.
Patients reported reduction in pain, discomfort, anxiety and depression, along with other quality-of-life improvements after three, six, 12 and 24 months following the procedure. The quality-of-life data is the largest regarding CoreValve’s performance and also longest-term data available from all transcatheter aortic valve implantation systems.
“… These results offer clear, mounting evidence that CoreValve is a truly transformational therapy for many patients with severe aortic stenosis, resulting in sustained clinical benefits and improved quality of life,” said Dr. Raoul Bonan, professor of medicine and interventional cardiology at Montreal Heart Institute.
While CoreValve is already being sold in Europe, it is only approved for investigational purposes in the U.S. where the product has not been immune from controversy. After Medtronic bought CoreValve in 2009 for $700 million, it inherited a patent infringement lawsuit charged by Edwards LifeSciences Corp. (NYSE:EW). The company’s name also came up in a lawsuit brought by a Mass. doctor against his employer. Dr. David Gossman of the Lahey Clinic Hospital alleged that he was fired because he resisted pressure to use Medtronic stents in exchange for the clinic’s ability to participate in CoreValve trials. At the time, a Medtronic spokesman said that a clinic’s participation in CoreValve trial is independent of the company’s commercial interests.
Medtronic began a U.S. pivotal study of CoreValve in its third fiscal quarter of 2011, which began in November 2010. In the past, Medtronic has said that its CoreValve revenue from international operations “continues to nearly double year-over-year and our share remained stable at approximately 50 percent.”
Here’s a roundup of recent clinical trial and scientific study news:
- Boston Scientific touts success of severe asthma treatment after five-year follow-up
Boston Scientific Corp. (NYSE:BSX) reported that their Alair bronchial thermoplasty system for severe asthma demonstrated stability and an absence of clinical complication in a five-year patient trial. The trial is part of the Research in Severe Asthma Trial, the third in a series of five-year follow-ups for patients with bronchial thermoplasty, a treatment involving the delivery of radiofrequency energy to airway walls.
- Avedro completes 1st U.S. Phase III Corneal Cross-Linking Clinical Trials
Waltham, Mass.-based Avedro Inc. announced completion of all one-year follow-visits for patients who participated in Phase III studies evaluating corneal collagen cross-linking treatment. The procedure treats keratoconus, a degenerative eye diease and leading cause of corniea transplants in the U.S., as well as complications that can occur after several types of eye surgery. Avedro won CE Mark approval for corneal collagen cross-linking in the European Union in April of last year.
- New breast imaging procedure shows promise in preliminary tests
Recent clinical evidence shared by Marcela Bohm-Velez and her colleagues from Associates in Pittsburgh, Pa. showed promise for low-dose breast imaging procedures, suggesting it may be possible to reduce radiation dose by up to 60 percent, from 20-30 mCi to 15, 10, or even five mCi without drastically reducing image quality. Ongoing investigations at the University of Va. could allow doses to be further reduced to between two and four mCi.
- New male circumcision device may help reduce HIV transmission
The Shang Ring, a sutureless male circumcision device, could make circumcision procedures less painful and easier to perform. The device is disposable and offers patients shorter procedure times of three to five minutes instead of the typical 20 to 40 minutes. Evidence has shown that male circumcision can reduce the risk of heterosexual HIV transmission by up to 64%. A study conducted by EngenderHealth and Weill Cornell Medical College found the device is culturally acceptable among African men, and safe for further study.
- Two-year data shows promise for coronary computed-tomography angiography
New data from two-year double-blind studies of 333 patients at Mass. General Hospital showed that computer assisted tomography has prognostic value in predicting risk of major adverse cardiovascular event. At least three larger, prospective clinical trials are currently underway.
- A better way to detect ovarian cancer?
A new study suggests that ovarian cancer could be more accurately detected using a new type of blood test, OVA1, the first test with FDA clearance to aid in pre-surgical evaluation of ovarian mass for cancer. Using the OVA1 blood test, researchers accurately detected 94 percent of cases, compared to 77 perent accuracy with the more common CA 125 test. Vermillion Inc. (NYSE:VRML) developed the test and Quest Diagnostics Inc. (NYSE:DGX) offers testing services.
- New handheld pain care monitoring device slated for testing at NYU
Baeta Corp. (PINK:BAEA) announced plans to initate tests of its MyHealth Trends for Pain handheld device which allows patients to quantify their discomfort and doctors to monitor pain levels. The NYU School of Medicine will conduct the trials to compare current pain care monitoring standards to BAETA’s device.
- Ark Specialty Orthopedics to host trial for iUni custom knee implants
Ark. Speciality Orthopedics. annonced that they will host ten-year follow-up tests for ConforMIS Inc.’s iUni custom knee implant system, which landed 510(k) clearance from the Food & Drug Administration in February.