Spearheading the Next Evolution
It is a ubiquitous fact that surgeries performed to mitigate heart impairments are one of the most risk oriented practices in the medical field. In various cases, the need plunges to go for a heart transplant surgery, which in itself, comes with a string of serious challenges. In the light of this, various medical organizations introduced their LVADs, but many fell short in crafting the appropriate device—one with the right size and resiliency in functionality, monitoring, and power consumption. “It was this stumbling block, which ReliantHeart picked up, studied, molded, and translated into HeartAssist5 (HA5), an LVAD that every surgeon, physician, and patient was waiting for,” says Rodger Ford, CEO, Chairman, and Co-Founder of ReliantHeart. After coming across the features and capabilities of HA5, William “Billy” Cohn, MD, Director of the Cullen Cardiovascular Research Laboratory at the Texas Heart Institute delineated, “when everybody sees the kind of value HA5 provides, I think it’ll be beneath the standard of care to have pumps that don’t have the underlying technology of HA5. I think it is the next evolution in the field of healthcare.”
Symbiotic Relationship with the Human Heart
HA5 is a tiny, lightweight device, positioned at the left ventricle to work in harmony with the human heart. The disparity between this LVAD and other devices comes from its ability to form a symbiotic relationship with the human heart—its performance is highly distinguished, yet equally simple. “HA5 effortlessly passes the pressure from the heart through the pump to produce a pulsatile continuous flow of blood to the body,” explains Ford.
HA5 gauges the flow, speed, and power on pre-defined thresholds, which sends alert messages whenever there is a deviation in these three variables
A prominent LVAD is defined by its capability to measure the rate of blood flow and occurring variations. Most of the approved LVADs calculate the blood flow as a derivative of speed and power—hence, are never accurate. “HA5 gauges the flow, speed, and power on pre-defined thresholds, which sends alert messages whenever there is a deviation in these three variables,” says Ford. Hence, if a set threshold of power is exceeded or a threshold of low blood flow is broken, clinicians are immediately warned and the patient can be evaluated for possible intervention.
Additionally, the data produced by HA5 is stored in the cloud. “The collected information is segregated by transplant centers to assess the condition of patients,” says Ford. Another scintillating feature of ReliantHeart’s LVAD is that it alerts doctors only when there is a breach in pre-defined requisites—assessing the situation before cautioning the authority. “This attribute is very important since remote monitoring can overwhelm doctors, just like the hundreds ofe-mails we receive everyday overwhelm us,” says Ford.
Leaving No Stone Unturned
The space of LVAD is dominated by three global names— ThoratecCorporation, HeartWare, and ReliantHeart. However, as they say, “innovation distinguishes a leader and a follower,”ReliantHeart with its innovative platforms, is trailblazing a new generation of medical devices. The U.S. Food and Drug Administration (FDA), which keeps a close eye on every medical activity, highlighted the complications involved in the practices of Thoratec and HeartWare. In their advisory bulletin, FDA outlined that, “Thoratec’sHeartMate II and HeartWare HVAD showcased an increased rate of pump thrombosis and a high rate of stroke respectively.” ReliantHeart was always vigilant about complications and the demands involved in the fabrication of LVADs. Unlike its competitors, ReliantHeart’s HA5 weighs only 92 Grams, over 100 grams lesser than Thoratec’s and HeartWare’s equipments.
With an effort to leave no stone unturned, ReliantHeart saw the importance of resolving the issues associated with Driveline infection. A dire threat for LVADs, Driveline infection was experienced by 18.9 percent of the 296 patients implanted with the HVAD in the HeartWare Endurance Study and 14.1 percent of the 149 patients supported by ThoratecHeartMate 2. It reveals that Driveline infections lead to the death of 3 percent of the patients implanted with an LVAD per year. To reduce this figure to as low as zero, ReliantHeart is coming up with ‘Disconnectable Driveline’ in this fall. “Disconnectable Driveline will make replacing the infected Driveline a seamless task,” says Ford.
"Disconnectable Driveline will make replacing the infected Driveline a seamless task"
A Window into the Future
Anticipation plays a key part in forging strategies for the future. A look into the forthcoming years provides the confidence to build a solid product foundation that facilitates future innovation. For the LVAD space, a recent study showcased that the potential market for medical heart devices is growing at a notable rate and may exceed 500,000 units per year. Just 5 percent of this surge represents $2.5 billion per year in annual revenue.
To walk parallel with this escalation, ReliantHeart is all set to unveil its latest technologies and innovation, which will further increase the quality of life for individuals suffering from heart impairments. By early 2017, HA5 patients will enjoy life supported by an LVAD without a wire penetrating the body. The implementation will be carried out by Transcutaneous Energy Transfer (TET), which will give patients the liberty to live a normal physical life. “Play and wrestle with the grandchildren without fear of the wire—that once penetrated the skin and body—being entangled in the fun. An HA5 patient can enjoy a walk on the beach or a night out dancing with ‘no wire’ to worry about,” concludes Ford.