A Medical Device Daily

Direct Flow Medical (Santa Rosa, California), a private company developing a next-generation, minimally invasive implant to treat patients with heart valve disease, reported completing its Series B financing and initiating clinical trials in Europe.

The company has developed a catheter-based system to replace the aortic valve percutaneously in patients with valve disease as an option to open surgery. The investigational device is an implantable pericardial tissue valve that allows simple delivery via a transfemoral approach.

Direct Flow said the device’s easy positioning — or repositioning — and retrieval features are intended to enable physicians to correctly size and place the device in its targeted location, “providing a new level of safety for patients.” The design also is intended to allow the physician to obtain full hemodynamic data and imaging prior to final device placement.

The company commenced its European clinical trial with the first device implanted in an 81-year-old, non-operative patient at University Heart Center Hamburg (Hamburg, Germany) under the direction of Joachim Schofer, MD, and Hermann Reichenspurner, MD, chief of cardiac surgery.

Monitoring the initial clinical case were Reginald Low, MD, an interventional cardiologist at the University of California, Davis and Steven Bolling, MD, a cardiac surgeon at the University of Michigan (Ann Arbor).

According to Direct Flow, the attending clinicians “agreed that the most important features of the device were its ability to function immediately upon expansion, allowing the patient to be hemodynamically stable throughout the procedure and that there were no perivalvular leaks with this unique product.”

“The trackability and ease of delivery of the Direct Flow Medical system due to its non-metallic construct will allow true percutaneous delivery in the future,” said Schofer. “We are very excited by the potential of this system and look forward to being involved in the rigorous initial clinical evaluation of the device.”

Johnson & Johnson Development Corp. and Foundation Medical Partners co-led the $27 million second round of financing and were joined by new investors VantagePoint Venture Partners and ePlanet, as well as existing investors, EDF Ventures, New Leaf Venture Partners and Spray Venture Partners.

“The company has a truly unique and proprietary design in what has become one of the most exciting new markets for cardiac device development,” said Lee Wrubel, MD, general partner with Foundation Medical. “The capital raised will allow the team at Direct Flow Medical to expand upon the significant progress they have achieved to date and to complete the clinical feasibility phase of device evaluation.”

Initially funded by EDF Ventures in 2004, Direct Flow completed its Series A round of private equity financing in August 2005 that was co-led by Spray Venture Partners and New Leaf Venture Partners.

Direct Flow was founded in 2004 by Gordon Bishop and Randy Lashinski. The company has 25 employees.

Monoderm sutures receive CE mark

Angiotech Pharmaceuticals (Vancouver, British Columbia), reported receiving CE-mark approval to begin marketing the Quill Self-Retaining System (SRS) Monoderm sutures in Europe. FDA clearance for the sutures was received in August.

The product is made by Quill Medical, a wholly-owned subsidiary of Angiotech.

“We are pleased with our accelerated pace in building out our North American Quill sales force, and we are making good progress in assembling a corresponding team in Europe to support this key catalyst product,” said Chris Dennis, senior VP, global sales & marketing.

“With these approvals, we can now focus on making the Quill SRS product line widely available in the U.S., Europe, Asia, and Latin America. [We] will continue to expand the Quill SRS product line to cover multiple procedures for wound closure and tissue approximation.”

Quill SRS Monoderm sutures, made from a rapidly-resorbing polymer, are intended primarily for superficial wound closure applications and indicated for soft-tissue approximation where use of an absorbable suture is appropriate.

The company said it anticipates that the Monoderm sutures will be available in various lengths and needle configurations, using three different diameters (USP sizes 0, 2-0 and 3-0).

Angiotech said the Quill SRS represents “a revolutionary technology in wound closure made possible by bidirectional fixation within the wound. Its patented design allows the surgeon to begin closure at the midpoint of the wound and suture in two directions from the midpoint.”

Barbs within the Quill SRS distribute tension across the wound and eliminate the need for knots. The company said the “highly efficient, knot-less system” can save “significant” procedural time in the operating room, while also enhancing wound closure.

Italian cancer center orders Mobetron

IntraOp Medical (Sunnyvale, California) said it has received an order to deliver one Mobetron to Centro di Riferimento Oncologico (CRO; Aviano, Italy). CRO is the fourth Italian hospital to have a Mobetron and the 23rd Mobetron ordered worldwide.

Mobetron is an FDA-approved, transportable electron-beam device designed for Intraoperative Electron Radiation Therapy (IOERT), or the direct application of radiation to a tumor while a patient is undergoing cancer surgery.

CRO currently performs IOERT by transporting the patient in the middle of surgery from the operating room to the radiation therapy department to receive treatment. The hospital currently treats primarily sarcoma and pancreatic cancer patients in their IOERT program, but having a Mobetron located in the operating room will allow it to treat a variety of other types of cancer, including IOERT for early-stage breast cancer.

Mobetron was a donation to CRO from a group of local private entrepreneurs that, with the help of Gruppo Oncologico Cooperativo Nord Est and Fondazione CRUP, were able to acquire the advanced IOERT technology. CRO is one of Italy’s leading cancer research centers.

Mauro Trvó, director of the radiation oncology department at the hospital, said, “This will be very important for the future development of IOERT, not only at our institute, but also in Italy. The CRO already performs IOERT with a conventional linear accelerator and this donationoffered us Mobetron, which we consider to be the best IOERT-dedicated treatment unit available at present.”