Medical Device Daily
Med-tech giant Medtronic (Minneapolis) might have regulatory approval with its Attain family of devices, which include cardiovascular therapies, but that's not stopping it from holding a trial to further test the efficacy and efficiency of the applications.
On Tuesday the company reported it has enrolled its first patient in the Attain Success trial, a prospective; post-market, global trial slated to include nearly 2,000 patients. The trial will evaluate implant success along with complication rates and procedure times in the market-released Attain Family of left-hearts leads and delivery systems portfolio.
The company said that data will be analyzed at baseline, implant and three months post-implant. Implant success and complication rates (up to three months), procedure times, handling feedback and physician survey data also will be captured in the Attain Success trial. A sub-study will assess final left-heart lead placement site. The company added that results are expected in 2.5 years.
In addition, study enrollees will have a Medtronic cardiac resynchronization therapy-defibrillator (CRT) device and use one of the following from the Attain family: Attain Command, Attain Select II, Attain Select, Attain Deflectable, or Attain Prevail catheters; or any other market released Attain model of delivery catheters, left-heart leads or guidewires.
"The study will specifically look at 15 new Attain Family therapy delivery products, which were commercially released in the last two years, including 13 catheters and two Medtronic-exclusive left-heart leads – Attain StarFix and Attain Ability," according to the company.
The company received FDA clearance for the Attain StarFix lead, which provides physicians with a new solution for achieving successful placement and stability of the left-heart lead in heart failure patients receiving a CRT device last year (Medical Device Daily, June 18, 2008).
The device is appealing, Medtronic said, because a patient's vein size or configuration can make it difficult to secure a left-heart lead in the optimal location.
Therefore, stable fixation of the left-heart lead is critical to a successful CRT implantation. Dislodgement of the left-heart lead may require additional surgeries, which could increase the risk of infection, the company noted.
The Medtronic Attain StarFix steroid-eluting unipolar lead has a 5 Fr diameter and is available in 78 cm, 88 cm and 103 cm lengths.
The Attain StarFix's design includes three soft, polyurethane lobes near the lead tip that, when expanded, enable stable lead placement in the target location. The lobes, which can be deployed to up to a 24 Fr diameter – about one-quarter inch – can be relaxed multiple times to allow for acute repositioning of the lead as necessary. Once deployed, the electrode is securely fixed in place, reducing the potential for dislodgement.
The second product that's being evaluated is the Medtronic's Attain Ability, which is reported to have the thinnest lead body of any left-heart lead that's on the market. This small size allows physicians to have a tool to deliver therapy directly to hard-to-reach areas of the heart.
The company received FDA approval of the application last Spring (MDD, May 14, 2009).
This application marks the first time a NASA-developed material has been used in this kind of implantable medical device. NASA's Langley Research Center created an aerospace resin, named Langley Research Center's Soluble Imide, or LaRC-SI. It is highly flexible, resistant to chemicals, and withstands extreme hot and cold temperatures.
The super plastic was determined to be biologically inert, making it suitable for medical use, including implantable devices.
"This broad portfolio of left-heart lead and catheter delivery tools help physicians address the needs of a range of patients, especially those with difficult-to-navigate anatomies," said John Hummel, MD, electrophysiologist with Ohio State University (Columbus), and global principal investigator for Attain Success. "This trial will explore how well these easy-to-use tools work to simplify and reduce the procedure time for physicians."
Omar Ford, 404-262-5546;