ReliantHeart is proposing a better way as it debuts the VAD Maintenance System at the ISHLT meeting. Clinicians will enjoy a close up and personal look at this novel system.
Houston, Texas (PRWEB) April 15, 2015
ReliantHeart, Inc., an innovative supplier of advanced mechanical circulatory assist technologies, and Cathtek, a unique manufacturer of catheters and related accessories, have teamed up to produce the VAD Maintenance System.
Literature review along with a survey of LVAD clinicians conducted in March 2015 reveal that nearly 10% of LVADs occlude with life-threatening thrombus blockage, About 750 to 800 LVADs clotted off in 2014.
LVAD patients suffer greatly from the current treatment options. Two, and only two, approaches are currently available to alleviate thrombus lodged in an LVAD:
(1) Inject a known thrombolytic solution, such as tPA at the inflow of the LVAD. The tPA is delivered via a catheter, however it is not confined to the LVAD and passes through the LVAD. More often than not, tPA causes catastrophic brain bleeds, and any freed thrombus particles may cause stroke.
(2) Exchange the patient’s pump. Pump exchanges are linked to high mortality rates, and are very costly.
“ReliantHeart is proposing a better way as it debuts the VAD Maintenance System at the ISHLT meeting. Not yet in trial, we are presenting what is expected to be the final design. Clinicians will enjoy a close up and personal look at this novel system,” said ReliantHeart COO, Anthony Williams.
The VAD Maintenance System is designed to antiquate existing dangerous and often lethal treatment methods.
Cathtek CEO Todd Cassidy explained: “The VAD Maintenance System includes two co-axial balloon catheters consisting of large inner lumens to aid in evacuating debris. The catheters are introduced through the left and right femoral artery. One catheter will inflate in the inflow side of the LVAD, while the other will inflate in the outflow side. Once the balloons have been properly placed and inflated the LVAD is successfully isolated from the patient’s body.
Once isolation occurs, clinicians have the option of introducing thrombolytic therapies and/or tools that they believe will aid in thrombus removal, all while the LVAD is sequestered from the patient. A final wash out of the LVAD using saline is the last step in restoring the LVAD.”
Clinicians attending ISHLT may visit the ReliantHeart booth for a personal explanation.
IDE Clinical Trial – United States: ReliantHeart Inc. is currently conducting an FDA Investigational Device Exemption (IDE) Clinical Trial on the HeartAssist5® Ventricular Assist Device System. The trial is a prospective, 1:1 randomized, multicenter, clinical trial to evaluate the safety and efficacy of 96 patients implanted with the ReliantHeart HeartAssist5® Ventricular Assist Device (VAD) System compared to 96 patients implanted with either a Thoratec HeartMate II® LVAD or HeartWare HVAD for left ventricular support while awaiting cardiac transplantation. The trial is expected to run through 2016. The HeartAssist5® is a device limited by Federal law to investigational use in the United States.
CE Mark – Europe: ReliantHeart HeartAssist5® Ventricular Assist Device is CE Mark approved for use in patients requiring ventricular support due to end stage heart failure. The HeartAssist5® is approved for bridge to transplant (BTT) patients awaiting cardiac transplantation and for destination therapy (DT) patients who are not candidates for cardiac transplantation.
ReliantHeart, Inc. is an innovative supplier of advanced mechanical circulatory assist technologies that are changing the approach to the treatment of advanced heart failure. It develops and manufactures the HeartAssist5® Ventricular Assist Device. ReliantHeart’s roots are in Houston, Texas, where it has been generously influenced by the transplant centers of Texas Heart, Methodist DeBakey and Memorial Hermann, and its technology originally inspired by NASA, the Johnson Space Center and Baylor School of Medicine.
Cathtek is a medical device manufacturing company founded in 2000, with specialized experience developing catheters and related accessories. Their first hand medical experience influences the design and manufacturing process due to their unique understanding of the needs of the customer and manufacturer , and the ideal choice for the patented ReliantHeart VAD Maintenance System. Cathtek’s experience is broad and runs from product concept, design to prototyping and manufacturing.
Specific areas of experience include insert molding of catheters and components, tipping and various secondary operations associated with catheter manufacturing. Clinical and regulatory experience is a bonus at Cathtek.