Biotronik launches PK Papyrus covered coronary stent

Biotronik said today that it’s launching the PK Papyrus covered coronary stent system for acute coronary artery perforations in the U.S.

When the FDA granted 510(k) clearance last September, the federal safety watchdog touted it as the first such device to win clearance for that indication in 17 years. About 1% of the 800,000 PCIs performed in the U.S. require a covered stent, according to Lake Oswego, N.Y.-based Biotronik, qualifying PK Papyrus for a humanitarian device exemption.

“The availability of PK Papyrus marks a long-overdue advancement in the field of interventional cardiology,” president Ryan Walters said in prepared remarks. “Clinicians can now rely on a low-profile covered stent during critical cardiac emergencies. In situations where every second counts, physicians can trust PK Papyrus to deliver quickly. Biotronik’s covered stent is designed to save more lives and to help avoid emergency bypass surgeries, which come with increased risk for patients and can be costly for hospitals. This is innovation that matters for hospital administrators, physicians and their patients, who deserve the best outcomes.”

from MassDevice http://bit.ly/2USTPCB

Bio-Rad loses bid to re-hear $8m loss to former GC

The U.S. Court of Appeals for the Ninth Circuit late last month shot down a bid from Bio-Rad Laboratories(NYSE:BIO) to rehear a decision to affirm a loss to a former general counsel in a whistleblower retaliation suit, according to recently released court documents.

Bio-Rad and its CEO had appealed a jury verdict in favor of former GC Sanford Wadler in which he alleged that the company terminated his employment after he blew the whistle on allegations that the company violated the Foreign Corrupt Practices Act in China.

A jury later ruled in Wadlers favor, finding that Bio-Rad violated the Dodd-Frank Act and the Sarbanes-Oxley Act, according to court documents.

In its decision, the appeals court vacated in part, affirmed in part and remanded the case, finding that the district court erred in specific jury instructions related to the Sarbanes-Oxley Act, but rejected an argument from Bio-Rad that a jury could not return a verdict related to the claims in Wadler’s favor.

The court did reverse a decisions related to a Dodd-Frank claim, and vacated approximately $3 million in damages attributable to the claim, according to court documents.

The case was sent back to the appeals court in February.

from MassDevice http://bit.ly/2U92ZWU

Admedus deals vaccines biz to Constellation Therapeutics

Admedus (ASX:AHZ) said today that it agreed to sell its vaccines business to Constellation Therapeutics in a deal that will see it own nearly 30% of the Chinese company.

Other shareholders in the vaccines would own another 11%, Queensland, Australia-based Admedus said. Sun Bright Holdings will own the remainder and put in $18 million until November 2022, in five $3.6 million installments pegged to “certain milestones,” the company said. Failure to pay an installment would trigger the conversion of 12% of Constellation shares to the Admedus bloc of vaccine business shareholders. Admedus CEO Wayne Patterson is slated to become chairman of Constellation Therapeutics as part of the transaction.

Last month Admedus won CE Mark approval in the European Union for its CardioCel 3D and VascuCel products.

from MassDevice http://bit.ly/2U5oY17

Angel Medical’s Guardian implantable heart monitor fails on efficacy endpoint

A clinical trial of the Guardian implantable heart attack monitor made by Angel Medical Systems failed to meet its efficacy endpoint, but suggested that the device could be used to help detect “silent” heart attacks.

Wilmington, Del.-based AngelMed won FDA clearance a year ago for the Guardian device for patients with prior acute coronary syndrome events including myocardial infarctions or unstable angina at high risk for further ACS events. Its 907-patient Alerts study randomized patients implanted with Guardian to either six months with the alert function active for the treatment group or six months without activation for the control arm; both groups had the alert function activated after the six-month randomized stage.

The primary efficacy endpoint, a confirmed occlusive event within 7 days, was not significantly reduced for the treatment arm at 3.8%, compared with 4.9% for the control arm. The primary safety endpoint was met a 96.7% rate of freedom from device-related complications, according to the study, published in the Journal of the American College of Cardiology and presented last month at the annual Cardiovascular Research Technologies conference in Washington, D.C., by principal investigator Dr. Michael Gibson.

However, the Guardian device cut detection-to-arrival-time from 30.6 hours to 51 minutes and an expanded analysis showed a higher predictive value and lower false positive rate for the treated cohort.

“Although the trial did not meet its pre-specified primary efficacy endpoint, results suggest that the device may be beneficial among high-risk subjects in potentially identifying asymptomatic events,” wrote the study’s authors, all of whom received research grants from AngelMed, including one who owns a stake in the company.

“As Dr. Gibson discussed in his presentation, the Guardian has shown that it can get patients to the ER even if they do not have symptoms of ACS events, including silent heart attacks. This is a first-ever capability for any product and allows the Guardian to fill an unmet medical need by providing more effective diagnosis of a life-threatening condition compared to relying on patient symptoms alone,” AngelMed CEO David Fischell said in prepared remarks.

Last last month the company emerged from Chapter 11 bankruptcy protection with a $10 million Series A round.

from MassDevice http://bit.ly/2UsFfCm

FTC grants final approval for Fresenius’s $2B buyout of NxStage

The U.S. Federal Trade Commission said yesterday that it granted a final order of approval to Fresenius Medical Care (NYSE:FMS; ETR:FRE) for its $2 billion acquisition of NxStage Medical.

The approval came with a caveat that the companies divest their assets and rights to research, develop, manufacture, market and sell NxStage’s bloodline tubing sets intended for use during hemodialysis treatment.

To mollify the anti-trust regulators, NxStage last July agreed to deal its Medisystems bloodlines business to B. Braun.

The final order was approved in a three-to-two vote, according to an FTC posting.

The $30-per-share deal for the Lawrence, Mass.-based home hemodialysis pioneer, first announced in August 2017, was initially slated to close by the end of that year. But it was delayed several times by the government shutdown this year and by the FTC.

from MassDevice http://bit.ly/2P2jXFr

Avinger wins FDA nod for Pantheris SV small vessel atherectomy device

Avinger (NSDQ:AVGR) said today that it won FDA 510(k) clearance for its Pantheris SV small vessel image-guided atherectomy system.

The Pantheris SV is an extension of the Redwood City, Calif.-based company’s lumivascular image-guided atherectomy platform which it hopes will expand the available market for its Pantheris devices by up to 50%.

The newly cleared device features a lower profile and longer length than the standard Pantheris, and is indicated for diagnosing and treating peripheral artery disease in small vessels between 2mm and 4mm.

“We are excited to receive U.S. pre-marketing clearance for Pantheris SV, which we believe could expand our addressable market for atherectomy procedures by as much as 50%. With the clearance of this new device, we are well-positioned to build on the positive momentum we have seen in our Pantheris business since the introduction of the next-generation system in 2018. Following our anticipated limited launch of Pantheris SV, we plan on leveraging our growing commercial infrastructure and installed base of Lumivascular accounts to efficiently scale up the introduction of Pantheris SV and drive growth of our Pantheris product family in the second half of 2019,” prez & CEO Jeff Soinski said in a press release.

The company said that it is planning to initiate a limited launch of the Pantheris SV at several U.S. sites, and that it expects distribution to expand as it builds product inventory and gains additional clinical experience.

“This product line extension represents a significant advancement for patients with PAD, in particular those suffering from the complications of small vessel disease. Treating small vessels presents a number of challenges and physicians have had a limited set of minimally invasive tools that can provide safe and effective outcomes for this high-risk patient population. Pantheris SV uses a combination of directional atherectomy with onboard image-guidance to provide several potential clinical advantages, including an enhanced safety profile, the ability to maximize luminal gain without causing vascular injury, and precise vessel measurement capabilities,” chief medical officer Dr. Jaafer Golzar said in a preapred statement.

Avinger said that the Pantheris SV won CE Mark approval in the European Union last October. The company submitted an FDA application for approval for the Pantheris SV last August.

from MassDevice http://bit.ly/2GcrxKN

Conformal Medical launches LAA seal study

Conformal Medical said yesterday that it launched an investigational device exemption trial for a device designed to seal off the heart’s left atrial appendage to help prevent stroke in atrial fibrillation patients.

Nashua, N.H.-based Conformal’s device is designed to adapt to the each patient’s individual physiology, to be easier to implant with less imaging and without general anesthesia. The 45-patient, single-arm study is designed to evaluate the device’s performance, with an estimated primary completion date of April 2020 and a final completion date of June 2025, according to ClinicalTrials.gov.

The primary outcome is freedom from adverse events at 45 days, defined as all-cause mortality, ischemic stroke, systemic thromboembolism, device- or procedure-related adverse events requiring open cardiac surgery or major endovascular intervention. Secondary outcomes include closure success at 45 days, 6 months and a year and major adverse events measured annually out to five years.

Conformal said the first-in-human use of the LAA seal, in a 63-year-old mountain biker with a history of bleeding episodes with anticoagulation drugs, was performed at the New York-Presbyterian/Columbia University Medical Center in New York City by Dr. Robert Sommer. The patient was discharged the day after his successful implantation on dual anti-platelet therapy per the study’s protocol, the company said.

“First-in-human use marks an important milestone for advancing our approach to stroke prevention,” president & CEO Andy Levine said in prepared remarks. “The experienced team at Columbia is providing valuable insights for optimizing the care of their patients.”

“It is exciting to participate in the first-in-human use of the Conformal device. The form-fitting seal is a promising advance in LAA closure for stroke prevention,” Sommer added.

“Columbia is excited to be the first to introduce this technology to patients,” Interventional Vascular Therapy Center director Dr. Martin Leon said. “I applaud Conformal’s commitment to utilize the FDA’s EFS Program. The ability to participate in early feasibility studies is important for the U.S. device ecosystem as we strive to develop new therapies to better serve our patients.”

Last December Conformal raised $9 million in a Series B round led by Catalyst Health Ventures that included some of its Series A investors.

from MassDevice http://bit.ly/2Gcix8t