Conformis: Yale study shows customized knee implants save money

ConformisConformis (NSDQ:CFMS) is touting results of a study that found that the average overall cost of care was nearly $1,700 less among Medicare patients treated with the company’s customized individually made knee implants.

Researchers at the Yale School of Medicine and Baker Tilly Virchow Krause conducted the study, which reviewed episode expenditures for all of 2015 among 4,434 Medicare beneficiaries, 739 receiving Conformis customized implants and 3,695 receiving standard off-the-shelf implants.

Results, presented at a recent Knee Society Meeting, found the average overall episode of care was $18,585 for patients with Conformis implants, versus $20,280 for patients with off-the-shelf implants.

Dr. Mary O’Connor, director of the Center for Musculoskeletal Care at Yale School of Medicine and the study’s lead researcher, described the study as the first long-term analysis of the economic impact of Conformis implants among Medicare-funded patients.

“The largest reductions in episode spending were associated with Conformis CIM patients who had overall fewer costs associated with the procedure and hospital stay as well as their post-acute care needs,” O’Connor said in a news release. (Note: O’Connor’s research institute receives support from Conformis, but O’Connor receives no personal compensation from the company.)


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Medtronic risk prediction tool could help prevent opioid deaths: Here’s how

Medtronic logo updatedMedtronic officials continue to hone their arguments for how the company’s capnography and oximetry systems could reduce potentially deadly opioid-induced respiratory compromise.

The medical device giant on Feb. 17 announced preliminary results of its Prodigy study, in which the company’s Microstream and Nellcor monitoring technology provided continuous capnography and oximetry for 1,496 patients across 16 sites in the U.S., Europe and Asia.

The study resulted in what Medtronic says is an easy-to-use risk prediction tool. Called the Prodigy score, it helps identify patients on the hospital general care floor who are taking opioid medications and are at high risk of developing a respiratory compromise.

The score takes into account variables including age, gender, sleep disorders, chronic heart failure and opioid naïvety. During the Prodigy study, it identified more than three-fourths of patients with confirmed respiratory depression.

Overall, opioid-induced respiratory depression occurred in nearly half of the patients in the study.

“Clinical evidence shows that acute and unexpected respiratory compromise on the general care floor is increasingly common. Until now, we have not been successful in predicting which patients are at high risk when recovering on the general care floor,” said Dr. Ashish Khanna, the primary study investigator and an associate professor of anesthesiology and intensivist at the Wake Forest School of Medicine.

“These data validate an easy-to-use [opioid-induced respiratory depression] risk prediction tool to identify patients at the highest risk and guide early intervention using continuous capnography-based monitoring. Early identification and intervention in these high-risk patients has the potential to improve patient safety and decrease the economic and clinical burden of unplanned ICU admissions,” Khanna said in a news release.

Opioid-induced respiratory depression is a “common, costly and deadly but preventable condition,” and Medtronic through the Prodigy study is committed to help, said Vafa Jamali, SVP and president of the Medtronic’s respiratory, gastrointestinal and informatics business.

“We are encouraged by the data demonstrating the use of the Prodigy OIRD risk prediction tool,” Jamali said. “It can help clinicians prioritize resources by identifying those patients at highest risk on the general care floor who should be continuously monitored with capnography and pulse oximetry.”



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Affluent Medical touts results of endovascular aneurysm repair study

Medtech startup Affluent Medical (Paris, France) said a study of its endovascular aneurysm repair (EVAR) system device showed patients had fewer endoleaks and needed fewer secondary interventions, and that their aneurysms shrank in volume and diameter.

The company’s Kardiozis endovascular prosthesis uses thrombogenic fibers to embolize an abdominal aortic aneurism sac during a conventional EVAR procedure to prevent endoleaks and the recurrence of the condition.

The Scope 1 randomized, controlled, multicentric clinical trial enrolled 102 patients at four sites in France, beginning in 2013. With a 24-month follow-up after implant, the study group of 46 patients had an endoleak rate of 47% compared with 78% for the control group. Aneurysm volume was reduced by about 55%, and no complications related to thrombogenic fibers embolization were observed, the company said.

Principal investigator Dominique Fabre, M.D., presented the results at the recent Controversies And Updates in Vascular Surgery congress in Paris.

“This is a long-awaited clinical improvement in EVAR outcome that can be standardized in a ready-to-use thrombogenic fiber-coated prosthesis providing the same functional embolization as in the SCOPE 1 study,” Fabre said in a prepared statement.

The Kardiozis technology can be applied both to existing endoprostheses on the market via corporate partnerships and to Affluent’s own endoprosthesis, which is under development, according to Affluent Medical CEO Daniele Zanotti. The company intends to launch Kardiozis in Europe by 2021.

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HeartFlow publishes findings from consumer survey

HeartFlowHeartFlow this week published the findings of a 1,500-person consumer survey, reporting that just 29% of respondents knew that heart disease is the No. 1 cause of death among adults in the U.S.

Half of the survey’s participants said that breast cancer is the leading cause of death among women, rather than heart disease.

“We are aiming to raise awareness that heart disease is the leading cause of death for both women and men. It’s not just a man’s disease, as commonly thought,” Dr. Campbell Rogers, HeartFlow’s chief medical officer, said in prepared remarks.

“The symptoms for women are often different than the classic ‘clutching of the heart’, so it’s important for both women and men to visit their doctor if something doesn’t seem right,” he added.

In the survey, 77% of respondents said they were worried about their heart health but 67% added that they’ve never sought out diagnosis or treatment.

HeartFlow also reported that 78% of the survey’s participants said they trust technology powered by artificial intelligence to assist doctors and that most respondents believe that a combination of technology and human analysis leads to the most accurate diagnosis.

“At HeartFlow, we firmly believe that technology will play an integral role in changing patient care for the better,” president & CEO Dr. John Stevens said in prepared remarks. “However, the physician’s role in the patient journey is crucial and we expect to see the best care administered only when doctors and technology work hand in hand.”

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Swedish patient receives ‘dexterous, sentient’ prosthetic hand

A researcher instructs the patient on how to move an artificial hand using the new implant.

A Swedish woman with a hand amputation has become the first recipient of an osseo-neuromuscular implant to control a dexterous hand prosthesis, according to Chalmers University of Technology in Gothenburg, Sweden.

Surgeons placed titanium implants in the two forearm bones (radius and ulna), and extended electrodes to nerves and muscle to extract signals to control a robotic hand and provide tactile sensations. Chalmers University and the European Dextrous Transradial Osseointegrated Project (DeTOP) declared it the first clinically viable, dexterous and sentient prosthetic hand usable in real life.

Get the full story and a video on our sister site, Medical Design & Outsourcing.

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Vectorious starts trial of implantable wireless heart monitor

Vectorious Medical Technologies said it has begun a first-in-human trial of its left atrial pressure monitoring device.

Tel Aviv-based Vectorious is developing the V-Lap implantable wireless heart monitor, which is designed to monitor pressure in the heart’s left atrium. The Vector-HF trial will enroll up to 30 patients at six sites across Germany, Israel, Italy and the U.K. The prospective, multicenter, single-arm clinical trial was designed to assess the safety and performance of the V-LAP system in preparation for receiving the CE Mark.

Vectorious said its V-LAP sensory device is the world’s first digital, wireless, battery-less device that can communicate from deep within the body using high-resolution waveform morphology. Because the pressure of the heart’s left atrium is the earliest and most accurate real-time indication of heart failure exacerbation, company officials believe the feedback provided by the V-LAP will enable a significant improvement in heart failure management. Patients implanted with the V-LAP will be able to measure left atrial pressure at home via a non-invasive method using a small, portable, external unit.

Horst Sievert, M.D., director of the CardioVascular Center in Frankfurt, Germany, performed the first implantation, completing it in just six minutes, the company said. Sievert fixated V-LAP within the interatrial septum of the patient’s heart using a standard, minimally-invasive percutaneous procedure under fluoroscopy and echocardiographic guidance, under local anesthesia.

“This technology will really change the way we manage patients with severe heart failure,” Sievert said in a prepared statement. “This is the first device that specifically enables us to monitor pressure within the left side of the heart, and because of its cloud-based system, we can access patient data on-demand, monitoring the atrial pressure and managing dosages, medications and overall quality of life consistently and remotely.”

“Implanting our first patient in the Vector-HF trial is a significant achievement that moves us closer to our goal of enabling optimal management for heart failure patients,” said Vectorious CEO and co-founder Oren Goldshtein. “This is very advanced technology that we hope will improve the future of chronic cardiac disease treatment.”

Investors in Vectorious include Fresenius Medical Care, Broadview Ventures, GoCapital, and China’s GEOC. The company has also received a $2.2 million grant from the European Union’s Horizon 2020 R&D program and the Israel Innovation Authority.

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Could this device replace pacemaker batteries?

Rendering of the two designs of Dartmouth University researchers’ cardiac energy-harvesting device. (Art by Patricio Sarzosa.)

The heart’s motion is so powerful that it can recharge lifesaving cardiac devices, according to new research from Dartmouth College.

Engineers at Dartmouth’s Thayer School of Engineering developed a dime-sized device to convert the heart’s kinetic energy into electricity to power a wide range of implantable devices, according to the Hanover, N.H.-based college.

Get the full story on our sister site, Medical Design & Outsourcing.

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Ortho RTi touts rotator cuff study results at conference

Startup Ortho Regenerative Technologies (CNSX:ORTH) said two new studies have validated its product’s ability to improve the repair of two distinct joint tissues – the rotator cuff tendon and articular cartilage.

The rotator cuff study results were presented yesterday at the Annual Orthopaedic Research Society meeting in Austin, Texas.

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Relievant back-pain device study stopped for positive results

Relievant Medsystems said it has halted enrollment in a clinical trial of its Intracept lower-back pain device due to the device’s superiority over non-surgical management.

The Level I Intracept study found a “highly significant reduction” in the Oswestry Disability Index (ODI) score in patients treated with the Intracept procedure over patients in the non-surgical management arm. The trial’s independent data management committee recommended that investigators stop enrollment and offer Intracept treatment to control-arm patients, according to the Minneapolis, Minn.-based company.

The interim analysis of the primary endpoint 104-participant trial demonstrated a 20.9 point difference in mean ODI reduction at three months between the Intracept arm and the non-surgical management arm. The Intracept-treated patients reported a 25.3 point reduction in ODI from baseline at three months. One-year results from a prior study released in February 2018 showed a statistically significant difference between patients treated with Intracept and a sham treatment cohort.

“This is the second Level I study that has demonstrated clinically significant improvement in pain and function for patients with modic changes on MRI and solidifies the Intracept procedure as a compelling early treatment option for patients with (chronic lower back pain),” said principal investigator Steven Garfin, M.D., interim dean, University of California San Diego School of Medicine, in a prepared statement.

“Stopping a Level I trial early for superiority is an extremely rare event and we are thrilled with this result,” said Relievant Medsystems CEO Kevin Hykes. “The Intracept procedure has demonstrated compelling and consistent clinical results in both sham-controlled and real-world Level I studies. The combined strength of these studies provides convincing evidence of the outcomes that patients and physicians can expect from the Intracept procedure.”

The full results of the Intraceptstudy are expected to be presented and published later in 2019.

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Boston Sci joins cyber-physical R&D collaborative

Boston ScientificBoston Scientific (NYSE:BSX)  has joined PracticePoint, a membership-based, cyber-physical medtech R&D and commercialization alliance founded by Worcester (Mass.) Polytechnic Institute (WPI).

PracticePoint is an agile, scalable collaborative research facility featuring point-of-practice clinical suites — including a residential suite, rehabilitative care suite, controlled care suite, and surgical imaging suite — co-located with engineering and manufacturing capabilities and test equipment, where devices and systems can be researched, developed, and tested.

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