Study establishes link between coronary artery disease and voice

Beyond Verbal announced the results of a new study on Coronary Artery Disease (CAD) patients, conducted together with the Mayo Clinic. The research shows that voice analysis can be used to identify the presence of CAD by establishing a strong correlation between certain voice characteristics and CAD. The study represents a significant breakthrough in this field, proving that there is a connection between distinct voice features and health conditions, which can significantly improve continuous monitoring and reduce remote healthcare costs.

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St. Jude Launches New PressureWire X Guidewire for Complex Anatomies Patients

St. Jude Medical announced the U.S. clearance and launch of the company’s new PressureWire™ X Guidewire fractional flow reserve (FFR) measurement system. The latest generation of the pioneering PressureWire™ Guidewire system is designed to offer improved shapeability and better shape retention aimed at reducing vessel trauma, with the accuracy and simplicity physicians expect when treating patients during percutaneous coronary intervention (PCI), especially those with complex anatomies.

A PCI procedure, or coronary angioplasty, is a non-surgical procedure designed to open coronary blood flow blockages and restore blood flow to the hearts of patients living with coronary artery disease (CAD)—the most common type of heart disease. PressureWire Guidewire FFR measurements are used by physicians to identify the severity of narrowings in the coronary arteries, which can result in more accurate diagnoses and improved treatment decisions for their patients. Although there are approximately 900,000 PCI procedures performed annually in the United States, only one in five of those are performed using FFR guidance.

“For years, clinical research has confirmed that fractional flow reserve is one of the most important tools available when assessing coronary lesions and making informed treatment decisions during percutaneous coronary intervention,” said Dr. Annapoorna Kini, the director of the cardiac cath lab and the director of the interventional fellowship program at Mount Sinai Medical Center New York, NY. “The improved design and shape retention of the new PressureWire X Guidewire tip allows us to perform FFR measurements in more tortuous anatomies.”

The use of FFR to optimize PCI is supported by strong evidence, and continues to be a topic of multiple clinical studies. In addition to launching the latest PressureWire Guidewire, St. Jude Medical has also launched the PRESSUREwire REGISTRY (Practical Evaluation of Fractional Flow Reserve (FFR) and its Association Alternate Indices During Routine Clinical Procedures), a multicenter clinical trial to determine the routine use of FFR measurement and clinical outcomes of FFR-guided PCI in patients with acute coronary syndrome (ACS), a major cause of global morbidity and mortality.

The PRESSUREwire REGISTRY will build upon clinical trials designed to assess the positive outcomes associated with FFR technology, such as the St. Jude Medical sponsored FAME (Fractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation) trials, which found that St. Jude Medical PressureWire guidewire technology can improve patient outcomes over angiography alone in patients with CAD.

The St. Jude Medical FAME trial body of evidence also demonstrated reductions in the risk of death or heart attack in patients undergoing PCI, as well as reduced health care costs for patients whose treatment was guided by FFR technology. Primary outcome two-year data from the FAME 2 trial showed that in patients with at least one significant coronary blockage with an FFR value of at least .80, FFR-guided PCI plus medical therapy reduced urgent revascularization by 77 percent compared to medical therapy alone. In 2015, five-year data from the FAME study confirmed the sustained, long-term benefits of FFR-guided PCI over angiography-guided intervention.

iBeat and Dr. Mehmet Oz To Launch Lifesaving Smartwatch

Mehmet Oz, called America’s Doctor by many, has joined with health tech startup iBeat to launch a breakthrough heart monitoring smartwatch that empowers people to live longer lives. The partnership with Dr. Oz will kick off with pre-orders for its iBeat Life Monitor – a watch that continuously monitors one’s heart for life threatening emergencies and notifies loved ones and emergency responders in such an event. A world renowned leader in cardiothoracic surgery, a transplant surgeon, and holder of eight patents, Dr. Oz has saved thousands of lives both in the operating room and by educating his millions of viewers. After seeing the massive impact potential of the iBeat technology in their San Francisco headquarters, Oz invested, partnered with, and joined on as Special Advisor to the company.

“The iBeat Life Monitor was designed to continuously measure and monitor one’s heart and potentially prevent fatal heart incidents,” said Dr. Oz, seven-time Emmy Award winning host of the nationally syndicated “The Dr. Oz Show.” “This medical-grade device not only provides users with a sense of safety and control over their own heart health – which is vital in the treatment and prevention of heart failure – but also allows their loved ones and family members to take a more observant role in their care as well. To make a positive impact on the health of others, I’ve learned that we need to make it easy to do the right thing. This device is not only a technological breakthrough that will be more effective than anything on the market, it fits into a person’s wardrobe with style and ease, making it simple to integrate its lifesaving properties in one’s everyday routine. As Special Advisor, I look forward to raising awareness around preventing life-threatening heart issues and highlighting a device that can truly save lives.”

The iBeat Life Monitor differentiates itself from other wearables on the market by continuously monitoring and analyzing user’s heart activity and instantly detecting the signs of oncoming cardiac arrest (a sudden cessation of heart function). If the device detects a life-threatening heart emergency, it will engage the user and ask if he or she is ‘OK.’ If the user selects ‘No’ or is unresponsive, iBeat will instantly alert the user’s loved ones and emergency responders in real-time, helping ensure immediate care delivery and potentially saving the user’s life.

The iBeat Life Monitor does not need a cell phone, mobile app, Bluetooth connectivity, or Wi-Fi to function. The device is fully cellular, while built-in GPS ensures the user’s loved ones and first response teams know exactly where the user is in an emergency. In such an instance, emergency contacts will get a text with a link showing where the user is and where they are in-transit so they can meet them at the hospital or nearby care center. Users will also have access to an online dashboard where they can see their daily, weekly, and monthly overall heart health (beats per minutes, heart pattern changes, etc.) and compare it to others within their age range. The device is also equipped with an Emergency-On-Demand button which, when long-pressed for two seconds, will allow users to reach out to their emergency contacts, or if needed, 911.

While the watch is primarily targeted at baby-boomers, especially those who live alone, and individuals with existing heart conditions, the device is receiving notable interest from younger adults and millennials who have parents and grandparents that could greatly benefit from the device. iBeat has already raised $1.5 million in funding from private investors and is looking to establish the market for the iBeat Life Monitor through pre-orders, as well as support the tooling and production line needed to bring the device to the masses.

“The early interest we’ve seen in iBeat has been remarkable,” said Ryan Howard, founder and CEO of iBeat. “We are excited to bring our device to the Indiegogo platform to drive even more awareness around the product and its ability to potentially save someone’s life. If you suffer a life-threatening heart incident such as sudden cardiac arrest, you have a 90% chance of dying without intervention. There are many devices on the market including diabetic monitors, heart-rate monitors, and other health monitoring solutions, but all these devices only passively monitor you. None of them actively monitor and analyze your heart health around-the-clock like the iBeat Life Monitor. Continual monitoring and quick intervention can mean the difference between life and death in emergency situations.”

Source: iBeat

Edwards INSPIRIS RESILIA Valve Receives CE Mark

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Edwards Lifesciences Corporation announced it received CE Mark for its INSPIRIS RESILIA aortic valve, the first in a new class of resilient heart valves. Incorporating the advanced RESILIA tissue, the INSPIRIS valve leverages features of the trusted PERIMOUNT Magna Ease valve and includes the proprietary VFit technology, which is designed for potential future valve-in-valve procedures.

A key innovation of the INSPIRIS valve is RESILIA tissue, a new, first-of-its-kind tissue platform that has been in development for more than a decade and builds on Edwards’ 40 years of leadership in tissue technology. RESILIA tissue utilizes Edwards’ integrity preservation technology, which preserves the tissue and provides improved anti-calcification properties and sustained hemodynamic performance. In addition, the valve is stored dry and ready to use.

A press release is available from Edwards website.

Boston Scientific Receives CE Mark For LOTUS Edge Valve System

Boston Scientific has received CE Mark for the LOTUS Edge™ Valve System, the company’s next generation transcatheter aortic valve implantation (TAVI) technology. The LOTUS Edge valve system is indicated for aortic valve replacement in patients with severe aortic stenosis who are considered at high risk for surgical valve replacement. Instead of open heart surgery, the replacement valve is delivered via transcatheter percutaneous delivery, a minimally invasive procedure involving a small incision to gain access to a blood vessel.

In comparison to the Lotus™ Valve System, this next iteration incorporates a more flexible, lower profile catheter designed to improve ease of use and accommodate tortuous anatomy. Another differentiating feature of the LOTUS Edge valve system is the inclusion of Depth Guard™, a design element intended to reduce the need for a permanent pacemaker (PPM).

A press release is available from Boston Scientific website.

Sunshine Heart Acquires Aquadex Product Line from Baxter

Sunshine Heart announced it has acquired the Aquadex product line from an indirect subsidiary of Baxter International Inc. The Aquadex system is indicated for temporary (up to eight hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization.

“Aquadex is an important strategic investment, which allows Sunshine Heart to strengthen our presence in the heart failure market,” said John Erb, Sunshine’s Chairman and CEO. “We believe Aquadex is a valuable and highly complementary technology to our expanding heart failure product portfolio. There is a real need for fluid management in patients both before and following any kind of heart failure procedure. Aquadex is used to treat fluid overload in congestive heart failure patients and can help reduce the length of stay while in the hospital and the number of hospital visits in total.”

Under the terms of the agreement, Baxter received $4.0 million in cash and 1.0 million shares of Sunshine Heart common stock. “This is a financially attractive transaction as well,” said Mr. Erb. “We expect this product line to be accretive in the first year with a relatively quick payback period. We plan to strategically leverage our current team of clinical specialists to directly support the existing base of Aquadex customers.”

In connection with the acquisition of this product line, the Company repaid all amounts outstanding under its existing debt facility with Silicon Valley Bank and entered into a new $5.0 millionfacility to finance future working capital needs. Advances under the facility are subject to various conditions precedent, including compliance with financial covenants, which the Company does not currently meet. “This strategic acquisition will allow Sunshine Heart to further drive important advancements to heart failure treatment,” said Ben Johnson, Managing Director of Silicon Valley Bank. “We’re excited to provide the financing to support the company as it matures to the next phase of development.”

A press release can be found from Sunshine Heart website.