Late mortality rates ‘inadvertently reversed’ in 5-year study of paclitaxel-eluting stent

Cook Medical - updated logoThe journal Circulation said this week that the all-cause mortality rates in a study comparing a paclitaxel stent and percutaneous transluminal angioplasty in people with peripheral artery disease were “inadvertently reversed” by the authors.

In the first version of the paper, originally published in 2016, researchers reported that the 5-year all-cause mortality rate for people treated with Cook Medical‘s Zilver PTX stent was 10.2% and 16.9% for the PTA group. But the correction reversed those numbers.

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Hancock Jaffe launches first-in-human VenoValve study

Hancock Jaffe Labs

Hancock Jaffe Laboratories (NSDQ:HJLI) said today that it launched the first-in-human study of its VenoValve device, touting its successful implantation in the first subject in the study.

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.

Hancock Jaffe said that the first patient in the Bogota, Colombia-based trial was walking a day after surgery and that the VenoValve appears to “be functioning as it should” with no early signs of thrombosis, reflux or other adverse events.

The trial aims to enroll an initial 5 to 10 patients with severe, deep venous chronic venous insufficiency. Patients in the trial will be implanted with the VenoValve and monitored out to six months with duplex scans to measure reflux time.

Endpoints for the study, which were announced last month, 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.

“We are so excited to get our VenoValve study underway and are thrilled that the first patient is doing so well. We will continue to monitor the patient for the next few weeks and then proceed with additional VenoValve implantations,” CEO Robert Berman said in a press release.

Hancock Jaffe said it plans to release preliminary data from the first group of VenoValve recipients during the second quarter of 2019, with patients continuing to be monitored out to six months.

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Medtronic: Patient deaths left out of paclitaxel-coated balloon analysis

Medtronic logo updatedMedtronic (NYSE:MDT) said last week that it inadvertently omitted an undisclosed number of patient deaths from recent studies of its paclitaxel-coated balloons.

The company noted that the mistake ultimately does not affect the conclusion that there was no statistically significant difference in all-cause mortality between its In.Pact Admiral drug-coated balloon and plain balloon angioplasty at five years.

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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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FDA expands indications for Medtronic’s Pipeline Flex embolization device

Medtronic logo updated

Medtronic (NYSE:MDT) said today it won expanded FDA approval for its Pipeline Flex embolization device.

The device is now indicated for patients with small or medium, wide-necked brain aneurysms in the territory from the petrous to the terminus of the internal carotid artery, the Fridley, Minn.-based company said.

The Pipeline Flex was previously cleared for the endovascular treatment of adults with large or giant wide-necked intracranial aneurysms from the petrous to the superior hypophyseal segments, Medtronic said.

Clearance came based on data from the 141-patient PREMIER trial of the device, which reported a one-year average occlusion rate of 76.7% with the use of 1.1 device per subject on average and an average 2.2% rate of major stroke or neurological death, the company said.

“Premier is another landmark study with Pipeline and moves the bar on the safe treatment of wide-necked brain aneurysms. This data changes the way we, as physicians, think about using Pipeline Flex to treat our patients,” principal trial investigator Dr. Ricardo Hanel of Jacksonville, Fla.’s Baptist Health said in a prepared statement.

The Pipeline Flex device is designed to divert blood away from aneurysms and features a braided cylindrical mesh tube intended to be implanted across the base of the neck of the aneurysm, which cuts off blood flow and reconstructs the diseased section of the parent vessel.

“Working hand-in-hand with physicians to develop new technology and clinical data is at the core of our mission. The Premier study not only demonstrated excellent safety and efficacy outcomes but also delivered on our commitment to broadening access to innovative therapies for new groups of patients requiring aneurysm treatment,” neurovascular biz GM Stacey Pugh said in a press release.

Late last month, Medtronic said that new study data indicated that its thoracic stent graft, intended for the treatment of a potentially deadly blunt-force chest injury, performed well at five years post-implantation.

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FDA doubles down on warfarin test strip recall

FDA-logo-newThe FDA this week alerted patients and doctors about test strips used to monitor levels of the blood thinner warfarin, expanding and reiterating its warning that the products shouldn’t be used to adjust a person’s drug dosage.

The agency’s latest notice is related to the Class I recall of Roche‘s CoaguChek meters and test strips, which the FDA issued in November last year. The initial recall involved more than 1.1 million packages of CoaguChek XS PT test strips that were distributed across the U.S. from Jan. 12 – Oct. 29 of 2018.

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

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Teleflex wins FDA PMA for Manta large bore vascular closure device

Teleflex

Teleflex (NYSE:TFX) said today that it won FDA premarket approval for its Manta vascular closure device, touting it as the first such device specifically designed for large bore femoral access site closures.

The newly cleared Manta device won indications for closing femoral arterial access sites while reducing time to hemostasis following the use of 10-20F devices or sheaths in endovascular catheterization procedures, the Wayne, Penn.-based company said.

“Our team has been working hard to obtain FDA premarket approval and were confident they would recognize the benefits that the Manta Device can provide to the patient. We have had great success with the device in Europe over the last two years with over 10,000 units sold, and are thrilled to bring this innovative solution to patients in the U.S. and further fulfill this significant and previously unmet clinical need in the structural heart and endovascular space,” device co-inventor & acess and closure division VP Greg Walters said in a press release.

Clearance of the device came supported by data from the SAFE MANTA IDE clinical trial of the device, which Teleflex touted as the largest US prospective multi-center, single-arm trial of such a large bore femoral access site closure device.

Results from the trial, which met its primary and secondary endpoints, indicated that the Manta device was able to produce fast reliable biomechanical closure and rapid hemostasis.

“I am very encouraged by the results of the SAFE MANTA IDE Clinical Trial. The clinically proven major complication rate (as defined by the study protocol) of 5.3% and VARC-2 major vascular complications rate of 4.2% compare very favorably to suture mediated devices and the 24 second median time (65 second mean time) from deployment to hemostasis was impressive. We have been patiently waiting for this approval, are eager to use the Manta Device commercially and look forward to the efficiencies it can provide,” co-principal investigator Dr. Zvonomir Krajcer of Houston’s Texas Heart Institute said in a prepared statement.

“FDA premarket approval is another important milestone for the Manta vascular closure device. Our commercial efforts in 2019 will include a measured launch of the Manta device to ensure strong initial outcomes with key thought leading physicians as we further invest in building the commercial infrastructure to support the long-term growth of Manta device revenues,” prez & interventional biz unit GM Stewart Strong said in prepared remarks.

Last November, Teleflex reported third-quarter earnings that topped the consensus on Wall Street and raised its earnings outlook for the rest of the year, sending share prices up.

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Reva Medical cuts 44% of workforce

Reva MedicalReva Medical (ASX:RVA) said this week that it plans to cut its workforce by 44%, leaving 22 employees at the San Deigo-based company.

In a statement, Reva CEO Reggie Groves cited current market conditions as the primary reason for the staffing reduction.

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Cook Medical wins FDA nod for Zenith aortic dissection repair stent

Cook Medical Logo

Cook Medical said today that it won FDA approval for its Zenith Dissection endovascular system intended to treat Type B aortic dissections.

The Bloomington, Ind.-based company’s newly cleared system consists of a proximal stent-graft component and bare stent distal component and is intended to prove a less invasive alternative to open surgery for repairing Type B dissections of the descending thoracic aorta.

“We’re pleased to provide another minimally invasive option for aortic repair. The approval of this product gives us an opportunity to have a positive impact on the lives of patients with aortic dissections. Cook Medical is committed to developing a variety of treatment options for aortic disease –from the arch to the iliacs, in order to help physicians fit a device to each patient’s unique disease state,” Cook Medical vascular division VP Mark Breedlove said in a press release.

Cook Medical said that it plans to launch the device in the U.S. in the coming months.

Last month, Cook Medical said that it inked a deal to buy a former cigarette manufacturing plant in North Carolina.

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