CoreMedic launches first-in-human study of ChordArt mitral repair device

German medtech developer CoreMedic this week announced the launch of a first-in-man trial of its ChordArt mitral valve repair device, touting the trial as the first of its kind to treat patients with ruptured or elongated mitral chords.

The company’s ChordArt implant is designed to replace ruptured or elongated mitral chordae and to re-establish the connection of the valve leaflets with the papillary muscle to restore functionality. In the trial, researchers will explore the use of the system in up to 40 patients at six European centers, CoreMedic said.

“The first clinical use of ChordArt is a major milestone in our path towards developing the best in class transfemoral mitral valve chordal repair system,” CEO Thomas Bauer said in a prepared release.

“In 2017 we invested in CoreMedic to advance the development of ChordArt. We look forward to the results of clinical trials that will validate the applications of this breakthrough device,” SHS managing partner Hubertus Leonhardt said in a prepared statement.

The first patient in the trial has already been treated by Dr. Kęstutis Ručinskas at Lithuania’s Vilnius University Hospital. The patient has reportedly recovered “very well” from the intervention and has shown no signs of complications at a 30-day follow-up.

“Using the ChordArt reduced the invasiveness and duration of the procedure by repairing the valve in a fast, precise and safe way. This allowed the Heart Team to focus on the procedure and timing rather than manually placing the artificial chords to resolve the mitral insufficiency. Thanks to the ease of the ChordArt deployment technique, this was the fastest mitral valve chordal repair I have ever witnessed,” Dr. Alberto Weber of Zurich, Switzerland, who proctored the procedure, said in a press release.

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Boston Scientific touts safety, effectiveness in Rhythmia mapping study

Boston Scientific‘s (NYSE:BSX) Rhythmia mapping system and catheter was found to be safe and effective in procedures to treat arrhythmias, according to a Healio summary of a newly released study from the company.

Researchers in the study examined 572 patients, with 519 patients undergoing procedures with the Rhythmia system and IntellaMap Orion catheter, according to the report. A total of 504 patients had a complete mapping procedure and were followed for one month post-procedure.

Findings from the study were presented at the EHRA 2018 meeting, according to Healio.

The primary endpoint of the trial was acute procedural success as defined by assessing the ability to map an arrhythmia or its substrate, completion of ablation applications and arrhythmia termination where applicable, with validation through appropriate techniques, according to the report.

Investigators reported that 83.3% of patients treated had successful procedures confirmed by arrhythmia-specific validation techniques. They also reported 96% success rate in treating cavotricuspid isthmus-dependent atrial flutter, 83% for non-cavotricuspid isthmus-dependent macro re-entrance atrial tachycardia, 81% for non-macro re-entrance atrial tachycardia, 80% for AF, 64% for ventricular arrhythmias and 94% for other arrhythmias, Healio reported.

Median time or map acquisition during procedures was 29 minutes and 41 seconds, with 73% of patients who had maps collected requiring additional ablation after validation mapping, according to the report.

A total of 61 adverse events in 49 patients were document, with 4% being ablation-related complications and 0.6% related to the mapping catheter, Healio reports.

“In most patients with substrate-based cardiac arrhythmias, electrophysiologic information about the properties of the substrate is key for the development of an appropriate treatment strategy. Currently, substrate-based arrhythmias constitute approximately 75% of all indications in interventional electrophysiology. This technology focuses on the key challenges in interventional and curative treatment of cardiac arrhythmias. However, until the True-HD study was completed, large-scale, multicenter data with more solid information on the mapping ability and properties, safety aspect and outcome, workflow and process effects had not been available,” Dr. Gerhard Hindricks of Germany’s Leipzig University Heart Center said, according to the report.

Yesterday, Boston Scientific released data from the Ranger SFA trial that showed that treatment with its drug-coated balloon succeeded in the femoropopliteal segment after one year and resulted in greater rates of patency, with fewer interventions, compared to standard balloon angioplasty.

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Medtronic launches study of drug-eluting stent as treatment for bifurcation lesions

Medtronic (NYSE:MDT) today launched a study to evaluate the safety and efficacy of its Resolute Onyx drug-eluting stent for the treatment of bifurcation lesions in patients with coronary artery disease.

The medtech giant said that bifurcation lesions make up nearly 20% of all percutaneous coronary interventions. The assessment of DES tech in this patient group is part of Medtronic’s post-approval study of its Resolute Onyx device.

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

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GI Dynamics touts insulin resistance improvement, weight loss in EndoBarrier meta-analysis

GI Dynamics (ASX:GID) today released results from a meta-analysis of its EndoBarrier device in helping patients with type 2 diabetes and obesity, touting improvements in insulin resistance and positive changes in weight.

The EndoBarrier device is a plastic gut sleeve designed to prevent the absorption of nutrients from food as it exits the stomach and enters the intestinal tract to treat Type II diabetes and obesity, the Lexington, Mass.-based company said.

Results from the analysis were published in the journal Diabetes Care.

In the analysis, researchers examined data from 17 published studies evaluating the EndoBarrier, with a primary outcome of changes in HbA1c and homeostatic model assessment of insulin resistant. Secondary outcomes were change in weight and change in hormones that are critical to the regulation of metabolic and bariatric disorders.

Results indicated a 1.3% reduction in HbA1c with use of the EndoBarrier, a 0.9% absolute reduction over control-arm patients in the studies being analyzed. At six months post-removal, HbA1c changes were reported at 0.9% with use of the EndoBarrier, while improvements in HOMA-IR were noted at 4.6, the company said.

Average weight loss reductions across the studies were noted at 11.3 kilograms, a decrease in 18.9% of total weight lost, or 36.9% of excess weight, according to the study. At 12 months out, total weight loss in the analysis was reported at 7.2% for patients who used the EndoBarrier.

“The analysis shows that DJBL is effective at treating diabetes in this patient population with a reduction in HbA1c of 1.3%, and with many patients coming off diabetic medication. This reduction in HbA1c is significantly better by 0.9% as compared to optimal medical management alone. In addition, this study demonstrates that patients who receive DJBL experience significant improvements in insulin resistance and weight loss, which persist up to at least six months after device removal. Given a rising pandemic of obesity and diabetes, DJBL may offer a highly effective treatment option for this patient population,” study author Dr. Pichamol Jirapinyo of Boston’s Brigham and Women’s Hospital said in prepared remarks.

“We are pleased to review the results from this comprehensive EndoBarrier meta-analysis that Dr. Jirapinyo and the clinical team at Harvard Medical School and Brigham and Women’s Hospital conducted. The results confirm that EndoBarrier produces a significant reduction in HbA1c and weight, significantly reduces insulin resistance and creates a hormonal effect similar in many respects to gastric bypass. This data clearly shows a very favorable treatment effect with significant treatment durability and a positive benefit-risk profile. This study presents the most comprehensive EndoBarrier meta-analysis we have seen and this type of data is indicative of EndoBarrier’s highly impactful clinical utility,” prez & CEO Scott Schorer said in a press release.

Earlier this week, GI Dynamics announced it inked a binding commitment for a $1.8 million financing deal with Crystal Amber Fund Limited.

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Minerva Surgical seeks retraction of Hologic-backed NovaSure study

Minerva Surgical is seeking the retraction of a study backed by rival Hologic (NSDQ:HOLX) comparing its NovaSure endometrial ablation system to Minerva’s competing device, alleging “material misleading statements” that violate ethics guidelines.

Results from the 189-patient study, published in the International Journal of Women’s Health, found a higher one-year rate of amenorrhea and higher quality of life for women treated with the NovaSure, despite a higher rate of perioperative adverse events.

But Minerva alleged last month that the study’s claim that it enrolled all 92 subjects treated with the Minerva system is demonstrably false, citing evidence that 256 patients were treated with its system at the study sites, “including 169 patients at the lead author’s clinical site alone.”

“Also troubling is Minerva’s understanding, as supported by one of the study site investigator’s, that Hologic personnel were on-site, and conducted the patient selection process. The same Hologic personnel had access to the patient charts (electronic medical records) at the clinics, and selected which Minerva patients and which NovaSure patients were enrolled in the study. This obviously biased patient selection process is not fully disclosed in the paper,” Minerva alleged.

The IJWH-published study also said that post-procedure bleeding was not reviewed or known at enrollment, despite the inclusion of such data in an earlier draft that was rejected by the Journal of Minimally Invasive Gynecology and the Journal of Gynecological Surgery, according to Minerva.

“Hologic’s access to the patient’s early post-procedure bleeding status, when combined with the study sponsor’s full control over the patient selection process, data collection, and analysis, resulted in a study population that was clearly biased in favor of the NovaSure arm of the study,” the company said. “Minerva believes that failure to disclose the actual methodology of a study constitutes a clear violation of the [Committee of Publication Ethics] guidelines, hides potentially significant selection bias, and distorts any study conclusions.”

The Redwood City, Calif.-based company said it lodged a formal complaint and retraction request with Dove Medical Press, which publishes the IJWH, with copies sent to Hologic and the FDA.

“We trust that Hologic will live up to its Code of Ethics published on their website that commits them to ethical conduct, to honesty, and to being truthful and upfront with customers and shareholders. We also trust that the International Journal of Women’s Health will live up to its commitment to abide by the COPE guidelines. Minerva looks forward to the timely announcement that the Int’l Journal of Women’s Health has retracted this publication,” Minerva president & CEO David Clapper said April 26 in prepared remarks.

Asked about the allegations during Hologic’s fiscal second-quarter earnings call, CEO Steve MacMillan said the IJWH study “will not be retracted.

“We feel very good about the underlying way that that study was done, so feel really, really good about that,” MacMillan said.

“Not only the clinical results that have come out and were published, but also some of the surveys, I think we’ve given our sales organization more tools to be able to be much more competitive in the marketplace,” added CFO Robert McMahon.

Hologic “strongly disputes” Minerva’s accusations, spokeswoman Jane Mazur told Stat.

“We stand by the integrity of the investigators’ data and appreciate the [IJWH‘s] rigorous standards,” Mazur told the website.

Minerva and Hologic are embroiled in an intellectual property spat over endometrial ablation technology that dates back to November 2015, when Hologic sued in the U.S. District Court for Delaware over the alleged infringement of a trio of patents (Hologic later asserted unfair competition, deceptive trade practices and tortious interference and infringement of a fourth patent). Minerva’s counter-claim contained its own allegations of unfair competition, deceptive trade practices and interference, plus breach of contract and trade libel; a trial is slated for July.

Minerva in April 2017 leveled another suit against Hologic and its Cytyc Surgical Products subsidiary, alleging that its NovaSure Advanced device infringes a Minerva patent; a trial in that case is scheduled for July 2020.

Meanwhile, the battle played out at the U.S. Patent & Trademark Office, where Minerva sought inter partes review of two of the Hologic patents and sought a post-grant review of a third. Although review was denied for one of the patents, the Patent Trial & Appeals Board in December 2017 invalidated all claims of the other; Hologic appealed in February, according to a regulatory filing. The post-grant review is still under way, according to the filing.

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OncoSec to combine ImmunoPulse device with Merck’s immunotherapy in breast cancer trial

OncoSec Medical (NSDQ:ONCS) expanded its relationship with Merck (NYSE:MRK) today, announcing a deal to combine its ImmunoPulse IL-12 device with Merck’s anti-PD-1 therapy, Keytruda, in a Phase II trial of patients with triple negative breast cancer.

The trial is slated to study the drug-device combination in patients with inoperable locally advanced or metastatic cancer who have failed at least one systemic chemotherapy or immunotherapy.

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

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J&J’s Janssen touts Ph3 data for antidepressant nasal spray

Johnson & Johnson‘s (NYSE:JNJJanssen revealed data today from two Phase III trials of its investigational esketamine nasal spray in patients with treatment-resistant depression.

The Titusville, N.J.-based company said that if approved by the FDA, esketamine would represent one of the first new approaches designed to treat refractory major depressive disorder in the last 50 years.

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

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Intuitive Surgical touts inguinal hernia study

Intuitive Surgical (NSDQ:ISRG) touted a 1,254-patient study today showing that patients who underwent robotic-assisted surgery using the da Vinci system to repair an inguinal hernia had fewer complications after 30 days compared to patients who had open surgery.

The study, published in Hernia: The World Journal of Hernia and Abdominal Wall Surgery, was characterized by Intuitive as the largest multi-center comparative study of robotic-assisted and open surgery for inguinal hernia repair.

None of the patients in the robotic-assisted surgery group returned for reoperations related to the inguinal hernia repair procedure after 30 days. In contrast, five patients who received open surgery needed reoperations.

Both procedures demonstrated similar rates of intra- and post-operation complications before the patient was discharged, Intuitive noted.

“Results from this study support the adoption of robotic-assisted, minimally invasive repair for inguinal hernia,” Dr. Myriam Curet, EVP & CMO at Intuitive, said in prepared remarks.

“Most inguinal hernia surgeries are still performed via open surgery,” Curet added. “The lower rate of complications after discharge through 30 days—especially the lower reoperation numbers—show that appropriately selected patients may benefit from minimally invasive surgery for this procedure.”

ISRG shares were trading at $455.97 apiece today in mid-morning activity, up +1.7%.

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J&J’s BioSense Webster launches Qdot Micro afib ablation cath trial

Johnson & Johnson’s (NYSE:JNJBiosense Webster said yesterday it launched a European trial of its Qdot Micro novel radiofrequency ablation catheter designed for treating paroxysmal atrial fibrillation.

The Irvine, Calif.-based division said that the first patient in the trial has already been enrolled and treated by Aalst, Belgium’s OLV Hospital.

“The concept of high power, short duration ablation is novel and a potentially groundbreaking advancement for the industry. This new modality could result in improvements in clinical outcomes and procedural efficiencies and I look forward to further investigation,” Dr. Tom De Potter of OLV Hospital said in a prepared statement.

In the Qdot AF study, researchers will examine the delivery of high power, short duration ablation with the Qdot Micro at eight European centers, expecting to enroll a total of 50 patients.

The Qdot Micro is a next-gen cath designed to treat AF in catheter ablation procedures, and can deliver 90 watts of RF power in a four-second temperature-controlled catheter ablation session, the company said. The catheter features optimized temperature control and micro-electrode technology for efficient and consistent lesion creation, the company claims.

The steerable, multi-electrode catheter is only available for investigational use in Europe, BioSense Webster said.

“Qdot Micro will be a significant advancement in catheter ablation technology that has the potential to elevate the standard of care for atrial fibrillation treatment. Biosense Webster has a legacy of leadership in cardiac ablation and we are excited by the prospects this new device may provide for millions of patients,” J&J medical devices cardiovascular and specialty solutions grouop chair Shlomi Nachman said in a press release.

In January, BioSense Webster said that the first patient has been enrolled in an investigational device exemption trial for its WaveCrest system.

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UPDATE: InVivo shares surge on release of 6-month results from cancelled Inspire trial

InVivo Therapeutics (NSDQ:NVIV) today has seen shares rise as much as 75% after it released complete six-month results from the company’s Inspire study of its neuro-spinal scaffold, which it ended in January after halting enrollment last July.

Results were presented by Dr. Stuart Lee of Vidant Health at the 2018 AANS meeting yesterday, the Cambridge, Mass.-based company said. The presentation was the first to include complete six-month data from the cancelled Inspire study.

InVivo’s neuro-spinal scaffold is a novel, biodegradable device designed to be surgically implanted following acute spinal cord injuries to act as a physical substrate for nerve sprouting.

A total of 19 patients in the trial were implanted with the neurospinal scaffold, with three patients dying within two weeks of implantation. Data indicated that 44% of patients who reached the six-month primary endpoint visit in the trial had an ASIA Impairment Scale conversion at six months, which was the primary endpoint of the trial.

The objective performance criterion for the study was a 25% AIS conversion rate based on published conversion rates for thoracic spinal cord injury as reported in literature, which the trial met, InVivo reports.

InVivo also presented results from the Contempo study, which was intended to provide natural history benchmarks for the neuro-spinal scaffold. The trial analyzed neurological recovery data from 170 patients across three registries of patients with spinal cord injuries similar to those in the Inspire trial. Results from the Contempo study “validated the company’s previously established OPC with AIS conversion rates,” the company said.

“I was honored to present these clinical findings at the AANS Annual Scientific Meeting, and I believe the complete six-month Inspire findings encourage future clinical investigation of the Neuro-Spinal Scaffold,” Dr. Lee said in a press release.

Shares in InVivo have risen 72.78% so far today, at $13.65 as of 2:38 p.m. EDT.

In March, InVivo said it won FDA investigational device exemption for a new pivotal trial of its neuro-spinal scaffold. The new trial is slated to enroll 20 patients with acute spinal cord injuries to explore the use of the company’s neuro-spinal scaffold in hopes that results will enhance existing evidence.

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