Johnson & Johnson, Apple ink collab for AFib study

Johnson & Johnson‘s (NYSE:JNJJanssen and Apple (NSDQ:AAPL) said today that the two companies inked a deal to study if an app from J&J in combination with the Apple Watch’s ECG app and irregular rhythm notifications can improve outcomes for people living with atrial fibrillation.

The study is slated to measure the impact of the Apple Watch on the early detection and diagnosis of AFib, as well as the efficacy of a medication adherence program.

Get the full story at our sister site, Drug Delivery Business News.


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Itamar Medical to raise $12m with private placement

Itamar MedicalItamar Medical (TASE:ITMR) said today that it stands to raise nearly $12 million in a private placement with American and Israeli investors.

Caesarea, Israel-based Itamar, which makes sleep apnea and heart failure diagnostic devices, said the round consists of $8 million raised from Deerfield Management, Triple Gate Capital, West Elk Partners, and Alpha Capital Anstalt. Another $3.5 million came from Israel’s More Investment House, the company said.

The placement was priced at ₪1.1693 per share (31.67¢) or $9.55 per American Depositary Share, each of which is worth 30 ordinary shares, Itamar said. The proceeds are earmarked for sales and marketing efforts for its flagship WatchPAT sleep apnea and EndoPAT heart disease devices.

Itamar said that, although the Israeli tranche is slated to close “within the next several weeks,” the U.S. tranche’s timing is uncertain “in light of, among other things, the continuing federal shutdown in the U.S.”

ITMR shares closed down -0.9% today in Tel Aviv, at ₪136.20 apiece (about $36.87).

($1 = ₪3.69187)

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Abbott to acquire mitral valve device maker Cephea Valve Tech


Abbott (NYSE:ABT) said today that it plans to acquire mitral heart valve replacement tech developer Cephea Valve Technologies for an undisclosed amount.

The Chicago-area healthcare giant backed the Santa Clara, Calif.-based valve company in July 2015 and secured an option to purchase it outright, which it has now chosen to exercise.

Cephea is developing mitral valve tech designed to be delivered through a vein in the leg and remove the need for open-heart surgery, Abbott said. Neither company has released any details of the acquisition.

“The acquisition of Cephea builds on Abbott’s strong position in structural heart therapies and is consistent with our strategy to develop comprehensive treatments for people with mitral valve disease. Cephea’s novel approach to replace the mitral valve adds to our other catheter-based technologies and is being developed to provide an additional option for patients who suffer from this difficult-to-treat disease,” structural heart biz VP Michael Dale said in a press release.

The newly acquired tech from Cephea will join other mitral valve-focused devices the company previously scooped up, including its MitraClip tech acquired in 2009 from Evalve and minimally invasive mitral valve systems from Tendyne Holdings, which it acquired when it originally invested in Cephea, Abbott said.

Earlier this week, Abbott won FDA pre-market approval for its Amplatzer Piccolo occluder intended for treating a congenital heart defect in neonatal infants as small as two pounds.

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Medtronic launches MyCareLink Heart pacer-connected smartphone app

Medtronic logo updated

Medtronic (NYSE:MDT) said today that it launched its MyCareLink Heart mobile application intended to connect users’s smartphone devices directly to the company’s portfolio of connected pacemakers, touting it as the first such mobile application of its kind.

The newly launched application is compatible with all of the Fridley, Minn.-based medical giant’s BlueSync technology-enabled pacers, and can wirelessly send device data to the company’s CareLink network, eliminating the need for dedicated bedside monitors and other remote monitoring tech.

“For the first time, pacemakers have the ability to communicate securely and directly with technology that patients use every day like smartphones and tablets. This brings the benefits of remote monitoring seamlessly into patients’ lives, potentially leading to enhanced and more efficient patient engagement with their physicians,” connectivity & insights biz GM Aisha Barry said in a press release.

Data collected by BlueSync-enabled pacers is encrypted and sent to the CareLink network through the mobile app, allowing physicians to monitor patients and receive alerts on clinically-relevant events, the company said.

The newly launched app also features the ability for patients to explore information about transmissions sent to their doctors and to receive confirmations of transmissions, track their vital signs and physical activity, display remaining battery life and catalog symptomatic events to be reviewed by physicians.

“The MyCareLink Heart mobile app is a technological game-changer for people with pacemakers. The introduction of convenient and secure data transmissions and easy access to information like pacemaker battery life changes how patients track and understand their heart health,” Dr. James Allred of Greensboro, N.C.’s Cone Health Medical Group Heartcare said in a prepared statement.

Earlier this month, major medtech players Medtronic and Boston Scientific (NYSE:BSX) said they will continue to support the use of their paclitaxel-eluting devices in the legs after a study released last month indicated a link between the devices and an increased mortality rate.

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Shockwave Medical launches U.S. pivotal for coronary lithotripsy

Shockwave MedicalShockwave Medical said today that it launched a U.S. pivotal trial for its coronary lithotripsy device, which is designed to prepare heavily calcified coronary lesions for stenting.

The technology uses sonic pressure waves to fracture intimal and medial calcium without damaging arterial tissue, Santa Clara, Calif.-based Shockwave said. Last April the Shockwave S4 catheter, designed to similarly treat peripheral arteries, won CE Mark approval in the European Union. The company raised $35 million in October 2017.

The two-year, 392-patient Disrupt CAD III study is designed to evaluate the safety and effectiveness of the Shockwave with the Shockwave C2 catheter in de novo, calcified, stenotic coronary arteries prior to stenting. The primary safety outcome is the rate of freedom at 30 days from major adverse cardiac events, defined as cardiac death, myocardial infarction or target vessel revascularization. The primary efficacy endpoint is the procedural success rate, defined as stent delivery with a residual stenosis of less than 50% and without in-hospital MACE, according to the company and

The estimated primary completion date is August 2020, with an estimated study close in July 2022. The co-principal investigators are Drs. Dean Kereiakes of Cincinnati’s Christ Hospital Heart & Vascular Center and Jonathan Hill of London’s King’s College Hospital. The study’s chairman is Dr. Gregg Stone of New York’s Columbia University Medical Center. Disrupt CAD III’s first patient was enrolled last week by Dr. Richard Shlofmitz of Roslyn, N.Y.’s St. Francis Hospital.

“After previously using the peripheral IVL technology – Shockwave M5 – to enable transfemoral access for TAVR as well as for mechanical cardiac support and hearing the enthusiasm from Europe about coronary IVL, we are very excited to investigate the clinical potential of the coronary technology in the United States,” Kereiakes said in prepared remarks. “This therapy holds tremendous potential from a safety perspective for patients and an ease of use perspective for physicians – if coronary IVL is shown to be safe and effective, it could be a game changer for the way we treat calcified arteries today.”

“Having treated nearly 100 patients with IVL since its European launch, the benefits for treating complex patients are evident. I am delighted to be a part of this important global trial to introduce my U.S. interventional colleagues to this novel technology. IVL is easy to use and has been a huge advancement for our management of calcified lesions,” Hill added. “I think U.S. interventionalists will recognize the simplicity and ease of use of the IVL system and will appreciate its ability to be rapidly deployed in any cath lab. I have no doubt that IVL is poised to become the key differentiating technology compared to other calcium modification tools.”

Last month Abiomed (NSDQ:ABMD) revealed plans to invest $15 million in Shockwave and collaborate on a training and education program in the U.S. and Germany.

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Hancock Jaffe sets endpoints for FIH VenoValve study

Hancock Jaffe Labs

Hancock Jaffe Laboratories (NSDQ:HJLI) today announced the endpoints for its planned first-in-human study of its VenoValve device.

The VenoValve is a porcine valve designed to be implanted into the femoral or popliteal vein to treat lower limb chronic venous insufficiency from damage to leg vein valves after deep vein thrombosis, the Irvine, Calif.-based company said.

Endpoints for the study include improvements in reflux time measured by duplex scans and rVCSS, VAS and VEINES scores, which are used as clinical measurements for venous disease. Hancock Jaffe said that patients in the trial will be monitored at regular intervals, with a focus on 90 and 180 day results.

The company has already won clearance in Colombia to launch the trial, looking to enroll five to 10 patients with severe chronic venous insufficiency.

“We have already received more than 100 inquiries from patients in Colombia wanting to participate in our study. Patients will be carefully screened under the supervision of Dr. Jorge Hernando Ulloa, our primary investigator in Bogota, and Dr. Marc H. Glickman, Hancock Jaffe’s chief medical officer.  Because results from the study will come relatively quickly, now is the appropriate time to begin to explain the terminology that we will be using to measure our success,” CEO Robert Berman said in a press release.

Hancock Jaffe said that data from the trial will be used to make design modifications to the VenoValve in preparation for a pivotal trial of the device in the U.S

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Thubrikar Aortic Valve launches Brazilian TAVR trial

Thubrikar Aortic Valve

Privately held medical device developer Thubrikar Aortic Valve said yesterday that it launched a Brazilian trial of its Optimum transcatheter aortic valve using the company’s implantation system.

The Norristown, Penn.-based company touted that the first human implant has been performed in the trial, which is being sponsored by the company’s Brazilian licensee, Labcor Laboratórios, who also manufactured the valve.

“We are very pleased to initiate this clinical trial of the licensed technology from Thubrikar and anticipate completion of the trial in 2019,” Labcor co-founder Dr. Ivan Casagrande said in a prepared statement.

“We are particularly excited to witness the success of the FIH of this important next-gen TAVI system, and we look forward to participating in Labcor’s clinical trial of these devices in Brazil,” Dr. Joaquin Coutinho of Pedro Ernesto said in prepared remarks.

The first implantation in the trial was performed by a team proctored by NYU Langone Health heart valve center director Dr. Mathew Williams, Thubrikar said, and took place at Rio de Janeiro’s Hospital Universitario. The valve was implanted percutaneously through the femoral artery, and the patient experienced no complications, the company said.

“Our system has demonstrated initial clinical feasibility and we look forward to ongoing clinical data of our technologies from Labcor. For a smaller company with less resources than many others in the TAVI field, for us to do FIH in eight years with a resounding success is making history. Furthermore, our preclinical data shows that our valve is comparable to surgical valves in durability, thus overcoming the last road block for TAVI to be used in younger patients,” founder & prez Dr. Mano Thubrikar, who invented the device, said in a press release.

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Villafaña-led vascular dev Medical 21 registers for $21m offering

St. Jude Medical founder Manny Villafaña’s newest medical play, Medical 21, has registered for an upcoming $10 million equity offering, according to a recently posted SEC filing.

The company, which was unveiled in late 2017, is developing an artificial blood vessel as an alternative to harvesting blood vessels for coronary artery bypass surgeries, and has already begun animal testing of the technology.

Medical 21 is using a new material developed by the University of Iowa and licensed to the company to make its artificial vessels. The material consists of cellulose graft conduits supported by a thin nitinol wire, similar to what was used in Villafaña’s previous start-up, Kips Bay Medical, which closed its doors in 2015.

So far, no one is listed as having joined the round, but the company expects that approximately $500,000 of funds raised will be used for paying executives at the firm, according to the SEC filing.

Medical 21 is keeping a low profile and has not yet released any official information on the round or updated on its developments.

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Amgen touts lowered prices for Repatha delivery devices

Amgen updated logoAmgen (NSDQ:AMGN) said today that it lowered the list prices of the drug-delivery devices for its cholesterol drug, Repatha, to $5,850 per year.

The Thousand Oaks, Calif.-based company touted the 60% discount as a way to boost patient affordability and accessibility.

Get the full story at our sister site, Drug Delivery Business News.

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JC Medical touts first U.S. treatment with transfemoral TAVR system

JC Medical logo updatedJC Medical said today that the company’s first U.S.-based patient was treated with its transfemoral transcatheter aortic valve implant system, J-Valve TF.

The FDA approved the use of J-Valve for people with aortic regurgitation through its “compassionate use” pathway. JC Medical also noted that it’s gearing up for a clinical trial of the investigational device in the U.S. this year.

The first U.S. patient to use JC Medical’s J-Valve TF system was treated at The Christ Hospital in Cincinnati, Ohio by Dr. Dean Kereiakes, who serves as the medical co-director of the Lindner Research Center.

“The J-Valve TF system has specific attributes that differentiate it from all other currently available TAVR systems, which I believe will enhance the safety and efficacy of TAVR for the indications of aortic valvular insufficiency (regurgitation) and possibly valve-in valve replacement of failing surgically implanted bioprosthetic valves,” Dr. Kereiakes said in prepared remarks. “J-Valve was clearly the best treatment option for our patient.”

“We are very pleased that our J-Valve could help this patient.  We developed the J-Valve to be reliable and suitable for treating a broad range of heart valve diseases,” Dr. Ji Zhang, founder & chief technical officer at JC Medical, added. “We thank the physician group who has recognized this unique clinical solution. Heart failure due to a defective aortic valve leads to a significant decrease in the quality of life, the loss of life for many, and costs the healthcare system billions of dollars annually. We look forward to further exploring the promise of J-Valve and its role in treating failing aortic heart valves.”

JC Medical’s investigational system is designed to restore normal blood flow out of the heart and into the body for people suffering from heart failure. The device includes an anchor mechanism that is linked to a self-expanding stent frame, which attaches to the failing native heart valve. The J-Valve also doesn’t necessitate calcification of the native valve, JC Medical noted.

In May last year, doctors in Vancouver performed the first clinical procedure using JC Medical’s J-Valve TF implant.

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