FDA approves Intact Vascular’s Tack dissection repair device

Intact VascularThe FDA last week granted pre-market approval to the Tack endovascular repair device developed by Intact Vascular.

The Wayne, Pa.-based company’s Tack system is designed to repair dissection complications during balloon angioplasty for peripheral artery disease. Intact said the federal safety watchdog based the April 11 PMA decision on the results of a pivotal, 213-patient single-arm trial that met both its safety and efficacy endpoints. The Tack device won CE Mark approval in the European Union in January 2017.

The Toba II study‘s rate of freedom from clinically-driven target lesion revascularization, amputation or all-cause death, its primary safety endpoint, was 86.5%. The trial met its efficacy endpoint with a 79.3% primary patency rate at 12 months. And 92.1% of all dissections were completely resolved, according to results presented at last year’s Vascular InterVentional Advances conference in Las Vegas by principal investigator Dr. William Gray.

Intact Vascular said the trial, which it touted as the first to enroll PAD patients with 100% dissected vessels, also showed 0.5% bailout stent rate and zero implant fractures.

“FDA approval of the Tack endovascular system comes at a dynamic time in the PAD market place. The Tack system’s unique combination of minimal metal and highly targeted dissection repair is an ideal fit with today’s focus on minimizing inflammation and improving long term outcomes,” president & CEO Bruce Shook said in prepared remarks. “Now with the Tack endovascular system available in both Europe and the United States, we look forward to expanding our commercialization efforts and continuing to improve the quality of life for PAD patients.”

“I look forward to having the Tack implant available for my patients,” added Gray, of Wynnewood, Pa.’s Lankenau Heart Institute. “Post-angioplasty dissections can significantly impact patient outcomes. Having a minimal metal solution that specifically addresses dissections and improves angioplasty results while preserving future treatment options is extremely exciting.”

Intact said it’s planning a limited U.S. release “that will progress toward broader market commercialization.” The company raised a $20 million Series C round in April 2018.

FDA clears Contego Medical’s Vanguard IEP peripheral balloon

Contego Medical's Paladin balloonContego Medical said today that it won 510(k) clearance from the FDA for its Vanguard IEP peripheral balloon, which features an embolic protection function.

“Securing FDA clearance for Vanguard IEP represents a major milestone for Contego Medical,” founder & CEO Dr. Ravish Sachar said in prepared remarks. “As the patient population with peripheral arterial disease continues to expand and become more complex, we believe our technology will play a critical role in protecting vulnerable patients from embolic events and thus improve procedural outcomes.”

“The Vanguard IEP System is designed to protect patients at high risk for embolization during peripheral angioplasty, such as those with acute limb ischemia, severe calcification, and chronic total occlusions if crossed intraluminally. It is also well suited to protect patients at high risk for complications should embolization occur, such as those with poor distal run-off,” added Dr. Thomas Zeller, of Bad-Krozingen, Germany’s Unversitaets Herzzentrum, and principal investigator of Contego’s Entrap study. “In our experience, the device has performed exactly as intended and we are impressed with the ease of use of the system, with no more exchanges required than in a typical angioplasty procedure.”

The post FDA clears Contego Medical’s Vanguard IEP peripheral balloon appeared first on MassDevice.

Study: Catheter thrombolysis doesn’t lower risk of post-thrombotic syndrome, raises bleeding risk

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thrombolysisA study of catheter-guided thrombolysis in patients with deep-vein thrombosis found no reduction in risk for post-thrombotic syndrome but a higher risk of major bleeding.

The study, published in the New England Journal of Medicine, examined 692 patients with acute proximal deep-vein thrombosis, randomized to receive either anticoagulation drugs alone or anticoagulation plus pharmaco-mechanical thrombolysis. The experimental arm was treated with the intra-thrombus delivery of recombinant tissue plasminogen activator and thrombus aspiration or maceration, with or without stenting. The primary outcome was development of PTS between 6 and 24 months.

The researchers found no significant difference between the groups in terms of PTS, which was found in 47% of the experimental cohort and in 48% of the control group. But there were more major bleeding events in the interventional arm within 10 days (1.7% vs. 0.3%).

However, there were no significant differences in recurrent venous thromboembolism over two yaers, with 12% occurring in the pharmaco-mechanical-thrombolysis group and 8% in the control group. Moderate-to-severe PTS occurred in 18% of patients in the treatment arm versus 24% in the control group.

Severity scores for PTS were lower in the interventional group than in the control group at 6, 12, 18, and 24 months, but “the improvement in quality of life from baseline to 24 months did not differ significantly between the treatment groups,” the study found.

“Among patients with acute proximal deep-vein thrombosis, the addition of pharmaco-mechanical catheter-directed thrombolysis to anticoagulation did not result in a lower risk of the post-thrombotic syndrome but did result in a higher risk of major bleeding,” the authors wrote.

Penumbra’s Q3 results top estimates

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PenumbraPenumbra (NYSE:PEN) yesterday reported third-quarter results that topped the consensus forecast on Wall Street and raised its sales outlook for the rest of the year, despite a nearly 100% profit slide.

The Alameda, Calif.-based medical device company posted profits of $238,000, or 1¢ per share, on sales of $83.9 million for the three months ended Sept. 30, which amounted to a -98.0% bottom-line plunge on sales growth of 24.9% compared with Q3 2016.

Analysts on The Street had predicted losses per share of -6¢ on sales of $79.2 million.

Penumbra said it now expects to report full-year sales of $324 million to $326 million, up from $312 million to $317 million previously.

PEN shares, which closed down -0.1% at $103.80 apiece yesterday, slipped a further -0.3% to $103.47 in after-hours trading yesterday.

In early, July, Penumbra paid $9.4 million (€8.2 million) for Crossmed, its exclusive distributor in Italy, San Marino and the Vatican.

Later that month, the company recalled 155 of its 3D Revascularization thrombectomy devices on the risk that wire breaks and separations could leave fractured wire pieces inside patients’ brains.

FDA clears Nitiloop’s Nova Cross micro-catheters

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NitiloopIsraeli medical device maker Nitiloop said today that it won 510(k) clearance from the FDA for a pair of its micro-catheters.

Netanya, Israel-based Nitiloop said the federal safety watchdog cleared its Nova Cross Extreme coronary micro-catheter and its Nova Cross BTK peripheral device.

“We are very excited at receiving FDA clearance for the Nova Cross Extreme and Nova Cross BTK, which further establishes our Nova Cross product family. We are encouraged by the positive medical community response to our new products bringing solution to one of the last un-met clinical need in the cath lab,” CEO Chana Schneider said in prepared remarks.

“With the continuing rise in CAD prevalence and increasing complexity of lesions requiring recanalization, the Nova Cross Extreme is a significant new addition to our tool box for tackling these lesions,” added Dr. William Nicholsonof Pennsylvania’s  York Hospital.

Nitiloop said it recently closed a 145-patient pivotal study of another micro-catheter, the NovaCross CTO, designed to cross chronic total occlusions in coronary arteries.

“The company submitted study results and is expecting FDA feedback within the next weeks,” Nitiloop said.