Cook Medical re-launches Beacon Tip caths in US, Canada

Cook Medical said today that it is re-launching its Beacon Tip Torcon NB advantage catheters in the US and Canada, after having recalled the devices due to complaints related to device tips on the items degrading and fracturing.

The Bloomington, Ind.-based company recalled all catheters that used its Beacon Tip locating technology in May 2016 over complaints of tip splitting, affecting a total of approximately four million devices.

The company 1st noticed the problem in early 2015, initially recalling only the smallest size Beacon Tip angiography catheter.

Cook Medical said its engineering team completed significant testing after the recall, and that the devices are now shipped with a new foil outer packaging to provide a barrier against environmental factors it identified as contributing to the recall.

“When we saw the catheters acting in unexpected ways without a clear root cause, we knew we had to recall. We knew the product was in high demand, and how heavily physicians relied on this product. But, patient safety comes first, period,” Cook Medical vascular division VP Mark Breedlove said in a press release.

Last month, Cook Medical said it won the second of three bellwether cases brought against it alleging that its inferior vena cava filters designed to capture and contain blood clots were defective.

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ReShape Lifesciences raises $6m in private placement

ReShape Lifesciences (NSDQ:RSLS) said today it inked a $6 million private placement of Series D convertible preferred stock and warrants with an institutional investor, with funds slated to support further product development and commercialization.

Units of the Series D convertible preferred stock are convertible into an aggregate of 8 million shares of common stock at a conversion price of 75¢ per share, while warrants offered will have a one-year term and will be exercisable for 35 million shares at an exercise price of 75¢ per share.

San Clemente, Calif.-based ReShape Lifesciences said it expects to receive $5.3 million after fees and expenses, but could be eligible for an additional $26.3 million in gross proceeds if warrants are exercised in full.

Exercising of the warrants would require shareholder approval, ReShape Lifescience specified, which it will request at its 2018 annual shareholder’s meeting, according to a press release.

Last month, ReShape Lifesciences said it plans to cut operating expenses by roughly 25%.

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Halyard Health dodges one suit, sees damages slashed in another

Halyard Health (NYSE:HYH) said late last week that it was granted a motion to dismiss a suit claiming it artificially inflated its stock prices, and that damages in another case were slashed by over 90%.

The Alpharetta, Ga.-based company said that it, along with a number of its executives, were facing a case claiming violations of the Securities Exchange Act. In the case, a group of shareholders alleged that Halyard misrepresented or failed to disclose information about the safety and effectiveness of its MicroCool gowns to inflate stock prices.

The company said it moved to dismiss the case in February, and that the court granted its motion on March 30.

Halyard Health said that in a separate case, in which it was facing punitive damages of approximately $100 million, those damages were reduced to $1.3 million. In the same case, punitive damages faced by its former parent company Kimberly-Clark were reduced from $350 million to $19.5 million, according to an SEC filing.

Total compensatory damages and punitive damages, alongside pre-judgement interest, was reduced to $1.6 million for Halyard health, and $24.4 million for Kimberly Clark, the company said.

In early March, Halyard said it was suing its former parent company Kimberly-Clark seeking to clear Halyard’s responsibility to pay for damages in a fraud case decided last April.

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Abiomed wins FDA nod for Impella CP with SmartAssist, taps Trapp as CFO

Abiomed (NSDQ:ABMD) said today it won FDA pre-market approval for its next-gen Impella CP heart pump with the SmartAssist optical sensor, and announced late last week that it named Todd Trapp its new CFO.

The newly cleared Impella CP with SmartAssist features improvements intended to simplify patient management, integrate clinical data informatics including left ventricular pressure, end-diastolic pressure and cardiac power output, and improve ease of use during set up and monitoring, the Danvers, Mass.-based company said.

“The ability to view fundamental hemodynamic data such as LVP, EDP and CPO directly on the Impella console provides critical information for clinical decision-making. Additionally, access to data and real-time pump position improves efficiency for nurses and physicians in the ICU and CCU,” William O’Neill of the Henry Ford Hospital said in a prepared statement.

Abiomed said it has already received CE Mark approval in the European Union for its Impella CP with SmartAssist, and added that more than 60 patients at three sites have been treated with the next-gen Impella CP.

“Abiomed would like to thank our physicians, technologists and nurses for their feedback on how to improve the Impella platform. Our scientists, engineers and clinical team are always looking for ways to improve our ease of use, training and clinical performance. Through innovation and research, our clinical team will utilize SmartAssist to help our customers achieve our goal to improve outcomes and enable heart recovery for every patient,” chair & CEO Michael Minogue said in a press release.

The company also announced that former Watts Water Tech CFO Trapp is joining as its new CFO. Prior to working with Watts Water Tech, Trapp spent 13 years with Honeywell International as financial planning and analysis VP and airlines biz unit CFO.

“I am very excited to join Abiomed, a company that has and continues to revolutionize patient care with its world class Impella technology. I am committed to working closely with the employees and shareholders to further grow the company and continue Abiomed’s tradition of strong execution,” Trapp said in prepared remarks.

“After an extensive search, we are pleased to welcome Todd Trapp to our executive team at Abiomed. Todd’s impressive proven record of accomplishment as a global CFO exemplifies his financial expertise, operational discipline and leadership. Todd will help Abiomed rise to the next level for the patients that we serve and our shareholders,” CEO Minogue said in a prepared release.

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Intersect ENT launches Sinuva steroid-releasing sinus implant

Intersect ENT (NSDQ:XENT) launched its steroid-releasing sinus implant, Sinuva, in the U.S. today. The company’s drug-eluting device is designed to treat nasal polyp disease in patients who have undergone previous sinus surgery.

Sinuva is placed during a routine doctor’s office visit and releases an anti-inflammatory steroid, mometasone furoate, directly to the patient’s nasal polyps for up to 90 days.

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

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Myriad’s breast cancer diagnostic wins approval in Japan

Myriad Genetics (NSDQ:MYGN) subsidiary Myriad Genetics Laboratories said today that the Japanese Ministry of Health, Labor & Welfare approved its Bracanalysis Diagnostic System to be used with Lynparza – a breast cancer drug marketed by AstraZeneca (NYSE:AZN) and Merck (NYSE:MRK).

Lynparza is a PARP inhibitor designed to target deficiencies in DNA damage response pathways. AstraZeneca and Merck are working to get the drug cleared in Japan to treat patients with BRCA-mutated metastatic breast cancer. Myriad’s Bracanalysis test is the first test approved in Japan for use with a PARP inhibitor, the company touted.

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

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Dexcom CEO on ‘treading new ground’ with G6 glucose monitor

Kevin Sayer sold his first glucose sensor in 1994. More than twenty years later, the chief executive of Dexcom (NSDQ:DXCM) still believes that glucose-monitoring technology can transform the way patients manage their diabetes.

This week, Dexcom won FDA approval for its latest continuous glucose monitor. The G6 system is the first of the company’s that does not require a finger-prick for calibration and is also cleared as “fully interoperable” with other medical devices, like insulin pumps and decision support software.

“This Gen 6 system brings to fruition all that I envisioned when I first saw a sensor in the 90’s,” Sayer told Drug Delivery Business News. 

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

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