from the December 2016 issue

Startups to compete for cardio invention of 2016

Contestants competing in Tel Aviv for the ICI annual innovation award include a tiny heart pump, and a diagnosis belt for the chronically ill.

Treat heart defects in newborn babies
A new surgical procedure to treat heart defects in newborn babies, the world's smallest heart pump, and a new indicator that makes it possible to know retrospectively if you've had a stroke - these are some of the inventions that took part in the "Cardiology Innovation of the Year" competition, in the framework of the ICI Meeting 2016, an international conference for innovations in cardiovascular systems from December 4 to 6 in Tel Aviv. The meeting directors were Prof. Rafael Beyar, director of the Rambam Health Care Campus in Haifa, and Prof. Chaim Lotan, director of the Heart Institute of The Hadassah-Hebrew University Medical Center in Jerusalem. Eight finalists were selected from among dozens of developments submitted by companies from all over the world.

NuHeart from Norway has developed the world's tiniest heart pump, inserted through the femoral vein. The pump weighs 10-15 grams, which compares with about 200 grams for the smallest pumps currently available, the insertion of which requires risky surgery. The product is especially suitable for children and other patient groups restricted in their ability to undergo surgery.

A patient sometimes feels symptoms that may stem from a slight stroke or heart attack, but existing imaging devices and blood tests are not always sufficiently accurate to tell for certain whether such an event is taking place or has taken place in the past. The information is important in order to know how to treat the patient, for an actual event or to prevent recurrence in the future.

Current practice is to carry out a blood test for a protein called troponin, which is released by damaged heart muscle. A group of researchers from Chile has developed a new test based on other proteins in the blood called circulation ECMVs, which are released as a result of changes in communications between cells. According to the researchers, this test has advantages over the existing one: it diagnoses the damage earlier, and is relevant to brain events as well, not just heart attacks. They estimate that they can produce a testing kit for $30. Heart surgery and catheterization procedures are carried out in conditions of high levels of radiation throughout the procedure. This radiation is damaging both to the patient and to the medical personnel. Ikomed Technologies Inc. of Canada, run by Israeli Eran Elizur, has developed technology that monitors the movements of the surgeon's eyes and instruments to determine where their gaze is focused, and then reduces radiation on the rest of the body by means of a lead shutter. The areas on which the surgeon is not focusing at a given moment receive lower radiation and less frequent pulses, so that an image is still obtained in case of some dramatic development in those regions but it is less sharp. The company estimates that it can obtain a ten-fold reduction in radiation levels to which patients and medical staff are exposed.

The system facilitates automatic focusing using sensors and algorithms developed by the company, or manual operation. The product developed by Haifa-based Vigor Medical Technologies Ltd. is aimed at people who sustain a blow to the chest that leads to blood or air gathering around the lungs in places where they should not accumulate. The correct functioning of the lungs depends upon pressure differences around the lungs, and when the pressure difference is incorrect, it is impossible to breathe and the injured person suffers lung and heart failure.

Irina Kavounovski, the company's director of medical equipment, says that when a person with this kind of injury is encountered in the field, a sealing device is attached to the patient's chest in the area of the injury, but it is hard to make stick because of the blood and dirt. After that, tubes are inserted to draw off the air through the sticker, or via the neck directly into the lung. These tubes tend to become blocked, and they are only a short-term solution, while when they are inserted via the neck they endanger the carotid arteries, and that is sometimes a worse injury than the trauma that required treatment in the first place.

An alternative is to sew a drain with a wider diameter in the injured area, but that requires a doctor and can take lace only under local anesthetic. Vigor has developed a device that is inserted via the wound, (or that can itself make a hole), and that immediately adapts itself to the structure of the wound, seals it, and leaves an opening via which a tube can easily be inserted. The device was designed is such a way as not to require a doctor; a medic can use it in the filed or in an ambulance without prior knowledge. The tubes inserted through it can be replaced more frequently, and narrower tubes can be used, causing less suffering to the patient, without fear that they will become blocked.

"After an injury we have an hour in which it is possible to save 50% of the patients who die from trauma of this kind. When we make the treatment accessible to a non-doctor, we make it possible to give treatment within this critical hour," says Kavounovski.

Kavounovski, relates how her mother suffered from the treatment using existing methods, and in the end died. The company was founded by her father, Igor Waysbeyn, and obtained finance from a US firm called Northlea Partners. It has taken part in the Technion accelerator and in the MassChallenge Accelerator in Boston, and has won various awards in international competitions.

Treating a baby's heart
Congenital heart disorders can dramatically alter the heart's shape, the directions of blood flow and the systems of valves and vessels that regulate the flow. Heart surgeons working in this field are required to show remarkable creativity, in-depth understanding of the flow theory and particularly precise hands, in order to operate on a newborn who is a few days or weeks old and in practice reshape the heart, in a way that will affect any future development, morbidity risks and life expectancy.

One example is the procedure developed by Indian surgeon Sanjib Moskwad as part of his PhD thesis. He treated a rare heart defect that appears in 6 out of 10,000 children in India, which does not enable their hearts to receive blood from the veins. In a healthy heart, after completing oxygen distribution throughout the body, the blood returns from the veins to the heart, is mixed there and then flows to the lungs to be further loaded with oxygen. In these children the heart must be bypassed and the veins connected directly to the lung.

At present, current practice among the few surgeons who operate in this field is to connect the lower vein, transferring blood from the lower part of the body, to one of the lungs, and the upper vein transferring blood from the upper body to the other. This, however, causes one lung to receive blood arriving from the liver, where it undergoes processes that enable it to collect oxygen, while the other receives blood from the brain and the head, where it does not undergo this process, leading to the imbalance between the lungs. Another option is to first connect these two veins in a cross, causing the blood to mix. However, in this case, the two blood flows collide and thereby lose substantial energy.

Moskwad's development is a rubber component inserted in this junction, enabling the blood to flow in a swirl, thereby preventing loss of energy, while dividing the two blood streams, the one from the liver and the one of the brain, equally between the two lungs. This product is inserted in a catheterization. The concept is currently being registered as a patent. A diagnosis belt for the chronically ill

The Indian company Uber Diagnostics has developed a belt worn on the patient's body, monitoring heart pressure, pulse and ECG indices. While there are many other entities developing wearables monitoring these parameters, Uber Diagnostics' product is unique in the way it conceptualizes product use. The company stores this data both on the cloud and in the device itself, turning it into what it defines as a 'mini medical record'. The device accompanies the patient, and could be displayed to any doctor he chooses, both routinely and in an emergency, in order to help monitor patient data and draw conclusions.

The products are earmarked for the Asian market and are aimed at enabling patients to more clearly see the link between the causes and symptoms of the illness and thereby 'take ownership of the disease' and be able to manage themselves better.

Vest for lung fluid monitoring
Lung fluid content constitutes an important indicator in determining whether a chronic heart failure patient is in the middle of seizure. The earlier this is diagnosed, the more quickly and easily that problem can be treated and deterioration in the disease prevented.

Israeli company Cardioset has developed a vest that could help patients monitor lung fluid leveby measuring the level of electrical resistance in a particular area of the lungs, compared with other areas covered by the vest. Trials carried out by the company have shown that the use of this product is capable of dramatically reducing mortality and hospitalization rates of heart failure patients. This monitoring will be carried out on a daily basis at the patient's home.

The electricians of the heart
Arrhythmia disorders cause heart damage and could result in the formation of dangerous blood clots leading to eventual blood vessel obstruction and a stroke. Among other things, arrhythmia is a result of a problem in electrical conductivity between heart nerves. It can be treated similarly to an electrical shortage at home, by applying insulation. The current practice is to cauterize certain areas of the heart muscle, using RF radiation. The cauterization causes controlled damage to tissue in the cauterized area, preventing the damaged tissue from conducting electricity - which is exactly the desired outcome, since reducing conductivity prevents the 'short-circuit' and restores the heart to a regular rate.

A group of researchers from Japan, headed by the Kyorin University surgeon Hiroshi Kubota, propose cauterization using infrared radiation instead of RF radiation. They claim that this will enable reaching into the heart's tissue (while still doing so in an accurate manner), making the insulation complete. Nowadays, the cauterization is not always deep enough, enabling the electrical current to pass through and cause the arrhythmia, even after surgery. That product has already undergone trials in 18 hospitals.

Reprinted from the Israel High-Tech & Investment Report December 2016

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