Lumendi wins FDA nod for DiLumen IS endoscopic scissors

Lumendi said today it won FDA 510(k) clearance for its DiLumen IS endolumenal interventional scissors, now indicated for cutting, dissecting and cauterizing tissue within the digestive tract during endoscopic procedures.

The Westport, Conn.-based company touted the sterile, single-use disposable, monopolar electrosurgical device as the fourth it’s developed, and said that it and its recently cleared DiLumen CT are intended to help improve access and therapy in the colon and reduce the need for surgical interventions.

The recently cleared C2  is a second-gen Endolumenal interventional platform designed to ensure complete positioning of an endoscope in the large intestine while also assisting with optical visualization, diagnosis and endoscopic treatment, the company said.

“The DiLumen platform of devices, now complemented by DiLumen Is, is designed to further facilitate and improve technically difficult and time-consuming endoscopic interventions for colonic lesions, such as polyps, a common condition that affects millions worldwide, and may replace invasive open surgical or laparoscopic procedures for patient benefit and potentially reducing healthcare costs,” CEO Dr. Peter Johann said in a press release.

Lumendi said that to date, its DiLumen EIP system has been used in more than 400 procedures with no reports of serious adverse device related adverse events, and added that three studies of the device have been completed with publication dates in the near future.

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Covalon is on the prowl, posts Q2 earnings

Covalon Technologies yesterday announced it is on the hunt for potential acquisitions alongside second quarter earnings results.

The Ontario-based company said it formed a special board committee looking to evaluate possible strategic alliances, partnerships and acquisitions as a response to a $100 million contract the company recently won.

“The board believes that the capital markets have not yet fully appreciated the impact of the highly transformative recent announcement of $100 million of contracted revenue over the next three years in addition to many other significant initiatives underway,” the company wrote in a press release.

Covalon said that it has already made steps towards a potential acquisition, having identified “a clear set of criteria for potential acquisitions” that would complement its internal growth. The company also announced plans for a potential buy-back of common shares, though the plans are subject to regulatory approval.

In its earnings release, Covalon posted losses of $479,082 on sales of $5.7 million for the three months ended March 31.

“Based on second quarter results and anticipated business in the second half of the fiscal year, the Company is very much on track to achieve year-over-year revenue growth for fiscal 2018, compared to fiscal 2017’s $27.3 million in revenue. Our revenue in the United States has more than doubled in the first six months of fiscal 2018, compared to last year. Our Middle East contracted deliveries are unfolding according to our delivery expectations, without taking into account any of the $100 million of contracted revenue over the following three years. I am very pleased with our performance year-to-date. More importantly, Covalon has never been on better financial and operational footing in its entire history. The Company currently has a clean balance sheet with no debt, has secured significant future contracted revenues, and has more than 150 United States FDA-cleared products and over 30 patents to protect its world-class technology platforms. We are working on many positive initiatives and are exploring many different expressions of interest,” prez & CEO Brian Pedlar said in a press release.

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LuxCath eyes the atrial fibrillation market

One problem with using ablation to treat atrial fibrillation is determining when the resulting lesion is sufficient to block the electric signals underlying the arrhythmia.

LuxCath thinks its OmniView catheter solves the dilemma by using an optical technology to assess metabolic activity in the ablated tissue, CEO Dr. Omar Amirana told MassDevice.com earlier this month during the annual Heart Rhythm Society meeting in Boston.

Amirana, a senior vice president at Allied Minds (LON:ALM), also helms Allied Minds subsidiaries SciFluor and Signature Medical and is a board member at CardioFocus. What drew him to LuxCath, he told us, is its ability to both visualize the ablated tissue and assess its viability.

“I’ve been an electrophysiologist since 1992 and I have not been able to find a technology that actively can see a lesion, in real time,” Amirana said. “This looks into the tissue, whereas everything else we’re looking at is right on the surface of the tissue, so you don’t have an idea of what’s going inside the wall of the muscle, and that’s really where recurrences occur.

“It’s kind of like a stud finder. If you’re looking for where to put the nail, basically, we tell you where the stud is,” he explained.

OmniView uses an optic fiber threaded through the catheter to shine light into the myocardium. If there’s poor contact with the catheter, the device doesn’t return a signature, Amirana explained. But if there’s good contact, the returning light excites a specific molecule that delivers information on tissue composition and lesion quality.

“It tells us whether we’ve got collagen and elastin in the tissue or whether we’ve got a healthy dose of viable myocardium that’s capable of conducting,” he said. “The way we determine that is we’re looking at the fluorescence properties of collagen which fluoresces at one wavelength and the fluorescence of [nicotinamide adenine dinucleotide], which is a molecule that’s inside metabolically active cells that’s required for basic metabolic activity.”

“What we’ve done essentially is added ports to the end of the catheter tip, so that we’re not only interrogating tissue that’s perpendicular, we’re interrogating all angles of contact. The big take-away for that is we’re not only going to assess catheter stability at all angles of contact and assess tissue composition, but also measure progression,” added LuxCath GM Arun Jaganathan.

With enough funding to carry through to CE Mark approval in the European Union, expected some time next year, and an 11-case first-in-human series under its belt using a prototype, Luxcath is developing the next iteration of OmniView and a clinical program to back the CE Mark bid and a parallel application with the FDA, Amirana said.

Dr. Vivek Reddy, who performed the first-in-human study, told us that although it’s early days yet, the OmniView catheter addresses an important gap in the EP toolbox.

“We assume that we’re ablating tissue based on the fact that electrograms diminish. But that’s a very crude way of interrogating information,” Reddy explained. “LuxCath is using a very clever way. Myocardium has a lot of [nicotinamide adenine dinucleotide]. So when you’re touching tissue, you suddenly see this peak of [nicotinamide adenine dinucleotide] and then when you ablate the tissue, that disappears. It’s an approach that will give you both contact information, as well as following lesion progression. I think it’s a very interesting, exciting one.”

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Getinge touts results from IABP study in MI patients with persistent ischemia

Getinge (PINK:GETI B) late last week released results from a pilot study of its intra-aortic balloon pump exploring its use with patients with extensive myocardial infarction complicated by persistent ischemia following primary percutaneous coronary interventions.

Results from the pilot study were presented by co-principal investigator Dr. Lokien van Nunen of Eindoven, The Netherlands’ Catharina Hospital at the EuroPCR 2018 annual meeting in Paris last week, the company said.

The prospective, randomized, comparative single-center Semper Fi pilot study aimed to evaluate the use of IABP in patients with extensive MI complicated by persistent ischemia after a PCI procedure, and included 100 patients with acute STEMI and insufficient ST-segment resolution as determined by an ECG 10 to 30 minutes after PCI in a cath lab.

Patients in the study were randomized to IABP for 12 to 24 hours or no IABP, and were followed up with at six months, Getinge said.

Results from the study indicated that those who presented with large acute MI trended towards decreased mortality, LVAD use and hospital readmission for heart failure within six months after IABP use. A total of 2% of patietns in the IABP arm experienced the primary endpoint versus 8% in the non-IABP group.

“Determining which STEMI patients will benefit from IABP has been difficult because of varying results from retrospective and prospective studies. We are encouraged by the results of the Semper Fi pilot study, which showed a strong signal that IABP may be beneficial in patients with extensive acute MI who continue to experience ischemia even after stenting. We expect that these results will bear out in a trial adequately powered to demonstrate a statistically significant reduction in the composite endpoint if this trend were to continue,” Dr. van Nunen said in a prepared statement.

“The trend toward a mortality benefit with the use of IABP observed in the Semper Fi pilot study is encouraging because the study was well controlled and did not allow crossover from the conventionally-treated group to IABP, which could have confounded the results. This pilot study is a testament to Getinge’s commitment to support clinical research to increase the body of knowledge for our life-saving therapies,” acute care therapies chief medical officer Dr. Claudius Diez said in a press release.

Earlier this year, Getinge said it won FDA 510(k) clearance for its PulsioFlex Monitoring System and PiCCO Module.

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Report: Trump to sign controversial law granting patients access to experimental drugs

President Donald Trump is slated to approve legislation this week that will give terminally-ill patients access to experimental drugs that haven’t yet been cleared by the FDA.

The “right-to-try” bill has sparked a great deal of controversy among policymakers and patient groups. While some, including the president, describe the effort as offering hope to patients with limited options, others argue that it undermines the FDA’s authority as the regulatory body charged with protecting patients.

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

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MIT researchers send drug-ferrying nanoparticles across the blood-brain barrier

Image courtesy of MIT

Researchers at the Massachusetts Institute of Technology demonstrated in an animal study that nanoparticles shuttling two different cancer drugs could effectively cross the blood-brain barrier and target tumor cells.

The team of scientists evaluated the drug combination in mice that had gliobastoma – an aggressive form of brain cancer that is notoriously hard to treat.

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

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TransEnterix surges on expanded indications for Senhance robot-assisted surgery device

TransEnterix (NYSE:TRXC) said today that it won expanded indications from the FDA for its Senhance robot-assisted surgery device, which is now cleared for hernia and gallbladder procedures.

The federal safety watchdog’s expanded 510(k) decision doubles the Research Triangle Park, N.C.-based company’s addressable market, president & CEO Todd Pope said in prepared remarks.

“These expanded procedures are commonly performed at over 95% of hospitals in the United States. We believe this indication expansion will significantly increase the applicability of Senhance to more institutions, particularly those with a busy general surgery practice,” Pope said.

“We have utilized Senhance broadly across a wide range of general surgery, upper GI surgery and colorectal procedures at our institution,” added Dr. Frank Willeke of Germany’s St. Marien Hospital. “We believe this procedural expansion for the U.S. will allow surgeons there to incorporate the Senhance, as we have, as a highly-efficient, enabling and very promising technology that can impact the vast majority of surgeries commonly performed by general surgeons and their sub-specialties.”

The news sent TRXC shares up 28.8% to $4.03 apiece today in pre-market trading.

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